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Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study
Psychiatry Research 235 (2016) 19–28
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Psychiatry Research journal homepage: www.elsevier.com/locate/psychres
Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study Lorenza Magliano a,n, Marta Puviani b, Sonia Rega c, Nadia Marchesini d, Marisa Rossetti d, Fabrizio Starace d, the Working Group a
Department of Psychology, Second University of Naples, Viale Ellittico 31, 81100 Caserta, Italy “Gulliver” Social Cooperative, Modena, Italy “Aliante” Social Cooperative, Modena, Italy d Mental Health Department of Modena, Italy b c
art ic l e i nf o
a b s t r a c t
Article history: Received 16 July 2015 Received in revised form 23 October 2015 Accepted 8 December 2015 Available online 11 December 2015
This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. & 2016 Published by Elsevier Ireland Ltd.
Keywords: Psychosocial rehabilitation Residential facilities Mental disorders Staff training Psychoeducation Controlled study
1. Introduction Psychosocial rehabilitation is an essential ingredient of care for people with severe and long term mental disorders (Anthony et al., 1990; WHO, 1996; Holloway et al., 2002; Anthony et al., 2003; Juckel and Morosini, 2008). Although many evidence-based rehabilitative interventions exist (Bradshaw, 2000; Marshall et al., 2001; Lucksted et al., 2012; Chien et al., 2013, Gühne et al., 2015), most of them are rarely available in routine settings, even in countries with long experience of community care such as Italy. A study of a representative sample of Italian mental health services (Magliano et al., 2002) revealed that only 35% of users with schizophrenia living in family received rehabilitative interventions, and that such interventions included the setting of personalized goals in 66% of cases, while only 8% of users' families received psychoeducational support. The availability of psychosocial interventions is even scarcer in n
Corresponding author. E-mail address: [email protected] (L. Magliano).
http://dx.doi.org/10.1016/j.psychres.2015.12.009 0165-1781/& 2016 Published by Elsevier Ireland Ltd.
psychiatric residential facilities, where users with poor levels of independent life skills and social resources are housed (De Girolamo et al., 2002; Killaspy, 2014; Stiekema et al., 2015). A survey on the process of care in 265 Italian residential facilities (Santone et al., 2005) found that a standardized assessment was performed in 38% of cases; an individual rehabilitation program was planned in 74% of cases; users were actively involved in written treatment plans in 35% of cases. Staff pessimism regarding the capacities of “chronic” users to successfully attend intensive rehabilitative programs may, in part, explain low turnover rates and the poor provision of structured interventions found in residential facilities. Although a homelike atmosphere was found in many Italian residential facilities, most of them had restrictive rules regarding patients' daily lives and behaviors, which may represent further obstacles to their acquisition of functional autonomy. In many circumstances, residential facilities represent “houses for life” (de Girolamo et al., 2002), where residents become cohabitants related to each other by affective relationships, and have daily contact with staff for years (Ljungberg et al., 2015). Although staff members may have less emotional investment in relationships with residents than relatives do, associations have been found
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between the quality of staff–resident relationships and residents' discharge rates (Berry et al., 2011). Therefore, the quality of therapeutic relationships between residents and staff is of central importance in residential facilities and may constitute a key resource for achieving favorable outcomes in severe mental disorders (Berry et al., 2011; Catty et al., 2011; Ghadiri Vasfi et al., 2015). Regrettably, as reported in a national survey of 1370 nonhospital residential facilities in Italy (de Girolamo et al., 2002), approximately 40% of residential facilities' staff had no specific professional qualification for working with people with severe psychiatric conditions. Literature data shows that it is possible to introduce evidencebased psychosocial interventions in mental health services after a relatively brief staff training (Magliano et al., 2006a; Quee et al., 2014; Stiekema et al., 2015), and that psychosocial interventions may improve functional outcomes of mental disorders when provided in routine settings (Falloon, 2003; Magliano and Fiorillo, 2007; Candini et al., 2013; Ghadiri Vasfi et al., 2015). For instance, a study carried out in 23 Italian mental health services on the implementation and effectiveness of family psychoeducational intervention for schizophrenia (Magliano et al., 2006a, b) found that this intervention, when provided by trained staff, led to significant improvement in patients' functioning at six-month follow up, particularly in social relationships, job interests, and management of social conflicts (Magliano et al., 2006b). Despite the above reported findings, no study has systematically evaluated the effects of psychoeducational group treatments when provided in residential facilities. Furthermore, when structured rehabilitative interventions were provided to users with schizophrenia attending day centers and residential facilities, significant improvement of functioning was achieved (Vittorielli et al., 2003; Gigantesco et al., 2006; Pioli et al., 2006; Velligan et al., 2008; Quee et al. 2014). A randomized controlled trial testing the effectiveness of an individualized cognitive-behavioral approach called VADO (Valutazione di Abilità e Definizione di Obiettivi; in English, Skills Assessment and Definition of Goals; Morosini et al., 1998) on functioning of users with long-term schizophrenia who attended day centers and residential facilities (Gigantesco et al., 2006) reported marked functioning improvement in the VADO group, and minimal changes in controls at six and twelve-month follow up. At twelve-month follow up, the difference in functioning level between the VADO and the control group was both statistically and clinically significant. Taking into account the above-mentioned findings, we developed a rehabilitation program Combining Individual VADO intervention (Morosini et al., 1998) with Falloon's psychoeducational Group Intervention (CIGI) (Falloon et al., 1984) to be introduced in psychiatric residential facilities. The program, in alignment with the World Health Organization's (WHO) psychosocial rehabilitation statement (1996), aimed to both improve competencies of users and introduce environmental changes in residential facilities. Moreover, in order to promote users' empowerment (WHO, 2010), the program was open to patients' voluntary participation in staff training and self-management of several psychoeducational group components. The program was applied from June 2011 to May 2013 in 8 residential facilities of the Department of Mental Health of Modena, Italy, as part of the annual staff training plan. In the same department, further 5 residential facilities not involved in the CIGI program, were used as Treatment-As-Usual (TAU) controls. This study aimed to explore the feasibility of introducing the CIGI in residential facilities and to verify whether, at two-year follow up, users who received the CIGI had better global functioning than those who received the TAU. The study questions were the following:
(a) Is it possible to train residential facilities' staff in a complex rehabilitative intervention, combining an individual evidencebased treatment with a group evidence-based treatment? (b) Are users living in residential facilities able to actively participate in the CIGI training and self-manage some aspects of this intervention? (c) Is the CIGI more effective than the TAU to improve users functioning at two-year follow up?
2. Methods 2.1. Design of the study This was a controlled, non-randomized study carried out from June 2011 to May 2013 in 13 residential facilities of the Department of Mental Health of Modena, Italy. The 13 residential facilities were managed by 3 social cooperatives that committed the study, in collaboration with the Mental Health Department of Modena, as part of the annual training plan for the staff. Therefore, key decision regarding the facilities' selection was taken by the commitments.The study was approved by the Ethics Committee of the Local Health Unit of Modena (No. 155/2011) and carried out in collaboration with the Department of Psychology of the Second University of Naples (SUN), Italy. 2.1.1. Participating sites Of the 13 residential facilities involved in the study, the 8 facilities located in the Central district of the Mental Health Department of Modena were selected to introduce the CIGI (CIGI residential facilities), while the 5 residential facilities located in the Northern and in the Southern district were used as TAU controls (TAU residential facilities). Two (25%) CIGI residential facilities and 2 (40%) TAU residential facilities had staff for 24 h a day, while 6 (75%) CIGI facilities and 3 (60%) TAU facilities had staff for r12 hour a day. 2.1.2. Eligible cases All users living in the 13 residential facilities were considered as eligible for the study. Informed consent for the collection and use of personal data for research purposes was obtained from each user and professional involved in the study. 2.2. Interventions 2.2.1. Combined Individual and Group Intervention (CIGI) The CIGI included an Individual component, the VADO approach (Valutazione di Abilità e Definizione di Obiettivi; in English, Skills Assessment and Definition of Goals), and a Group component, the Falloon's psychoeducational approach. The VADO approach (Morosini et al., 1998) is a manualized, cognitive-behavioral intervention described in a handbook also including several assessment instruments. The VADO, developed in line with WHO psychosocial rehabilitation principles (WHO, 1996) and inspired by the Boston Rehabilitation Center's approach (Anthony et al., 1990), is based on: (a) the assessment of the user's capacities and disabilities, performed by using the VADO's Functioning Assessment interview and the Personal and Social Performance (PSP) scale; (b) the negotiation with the user of realistic goals achievable in 3– 6 months, each planned by using the VADO's Goal Plan form; and (c) the evaluation of progress towards achievement of each planned goal, monitored by using the VADO's Rehabilitative Areas form (in “Description of the Instruments”). In the CIGI, the VADO approach was used to develop individual rehabilitation plans to be revised by the staff with each user, weekly over the study period. The Falloon's psychoeducational approach (Falloon et al., 1984;
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Falloon, 2003) is a well known cognitive-behavioral family intervention. Its basic components are: (a) the assessment of individual and family needs; (b) information sessions about mental disorders, their treatments, and relapse prevention, in which patients are considered experts of their own mental disorders; (c,d) communication and problem solving skills training based on sessions with therapists and relatives' self-managed meetings (without therapists); and (e) exercises to facilitate skills generalization. In the CIGI, the psychoeducational approach was applied with the users as a group. Over the two year study period, professionals held weekly group sessions on psychoeducational components and prompted the users to hold self managed weekly meetings (without professionals) “as if they were family members”, and to do group exercises (Fig. 2). 2.2.2. Treatment-As-Usual (TAU) The TAU was the routine rehabilitation approach used in the other 5 residential facilities. TAU included individual programs developed by the staff for each user, and group activities planned by the staff for all users. The individual programs consisted in staff support to users in performing self-care and care of personal life environment activities, in managing money and using public transports, and in limiting the adoption of at risk health behaviors (i.e., smoking, abuse of alcohol and coffee). Individual programs were not based on negotiation and setting of written individual goals with each user, and they did not include time defined goals. The individual programs were updated yearly by the staff without involving the users. In the TAU residential facilities, users were expected to collaborate in housework activities according to shifts defined by the staff (cleaning the house, tidying things up, cooking), and to participate in several group activities with rehabilitative potentialities, such as art laboratories, parties, excursions and supported holidays.
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module, techniques were revised and difficulties encountered in real world situations were addressed using a problem solving approach. During the year following the course, trainees attended five peer to peer 3 h supervision meetings to share their experiences. In the first module, the 31 selected CIGI professionals were trained in the use of the VADO's Functioning Assessment interview, Personal and Social Performance assessment scale (PSP), Rehabilitation Areas form and Goal Planning form. In the interval between the first and the second module, the CIGI professionals were invited to held a workshop in each CIGI residential facility aimed to: (a) inform all staff and users about the CIGI; (b) invite users to voluntarily participate in the subsequent training modules; and (c) request informed consent to each user. In the same interval, the CIGI professionals were asked to administer the Functioning Assessment interview and the Personal and Social Performance assessment scale (PSP) to each resident staying in the 8 participating facilities at that time, and to set at least one goal with each resident using the VADO planning tools. In the subsequent modules, users who voluntary attended the training course were involved in plenary sessions and working group exercises with the staff. The characteristics of the CIGI training, developed in line with WHO recommendations to promote users' empowerment in mental health (WHO, 2010), are summarized in Fig. 2. 2.4. Outcomes The primary outcome of the study was the improvement in users' functioning, assessed in terms of increase in global score on the Personal and Social Performance scale (PSP). The secondary study outcomes were the reduction of users' disability in the main areas of functioning, as assessed by the Functioning Assessment interview, and the increase in PSP global score for each diagnosis in the CIGI group.
2.3. Training in the CIGI 2.5. Assessment procedures 2.3.1. Participating staff Among all stable staff with permanent employment contract working in the 8 CIGI residential facilities (N ¼ 58), the following professionals were selected to attend the CIGI training course: the psychiatrists (4/31, 12.9%) and the nurses (3/31, 9.7) of the mental health department providing clinical care in the CIGI facilities; the Coordinators (8/31, 25.8%) of each residential facility; all rehabilitators/educators (9, 29.0%), and healthcare assistants (6, 19.3%) directly involved in the development of individual rehabilitative plans. One clinical psychologist attending his post degree training in one of the CIGI residential facilities was also accepted as participant (3.2%). The 31 selected professionals had a mean age of 38.9 79.3(SD) years, 23 (74.2%) were females, 19 (61.3%) were single and 19 (61.3%) were highly educated. Participants had worked in the mental health field for 11.8 78.9 (SD) years on average, and 14 (45.2%) had attended rehabilitation training courses in the past.
At baseline and again at two years from the start of the training course, the Functioning Assessment interview, and the PSP were administered to each resident staying in the 13 participating residential facilities at that time by trained professionals. In the 8 CIGI residential facilities, the assessments were performed by the staff as part of the CIGI package, while in 5 TAU residential facilities, the assessments were performed by the professionals who provided TAU and who had been previously trained in the use of the VADO's Functioning Assessment interview and Personal and Social Performance scale. Over the two year study period, in the CIGI residential facilities the following were registered: (a) the number and type of goals set and achieved by each user; (b) the number and content of group sessions held by professionals; and (c) the number and content of users' self managed meetings. 2.6. Description of Instruments
2.3.2. Training course procedures The training course consisted of five 1.5 day modules (12 h each) with a 30–45 day interval between each one, followed by two one day modules (8 h each), held for the most part at participating residential facilities. In the modules, the VADO techniques and the psychoeducational group techniques were addressed. Guidelines, working group exercises, and ad hoc role- play scenarios developed by a researcher of the Second University of Naples, Italy (L.M.) were used. In line with a “learn and do” approach (Johnson and Johnson, 1974; Kolb, 1984), participants were asked to apply the techniques at the residential facilities immediately after each one was addressed in each module. In each subsequent
The Functioning Assessment interview is a semi-structured interview exploring the user's capabilities and difficulties in 28 functional domains in the past month (described in Gigantesco et al., 2006). Domains are grouped in four main areas of functioning: self-care; socially useful activities, including work and study; social and family relationships; and disturbing behaviors. Each area is rated on a 6-level scale, from 0, “no dysfunction,” to 5, “very severe dysfunction,” using operational criteria (reported in Morosini et al., 2000). The Personal and Social Performance (PSP) scale provides a functioning global score computed on the basis of the main area
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scores explored by the Functioning Assessment interview. The PSP global score ranges from 100, “excellent functioning,” to 1, “extremely severe impairment.” Scores are grouped into ten 10-point levels on the basis of degree of difficulties and number of main areas in which difficulties have been observed. The PSP has been originally developed in Italian as part of the VADO manual (Morosini et al., 1998) and then validated in a sample of patients housed in residential facilities (Morosini et al., 2000). Subsequently, the PSP has been translated and validated in several other languages (Brisson et al., 2008; Srisurapanont et al., 2008; Garcia-Portilla et al., 2011; Wu et al., 2013). The PSP's psychometric properties have been repeatedly tested and found satisfactory in sample of patients with severe mental disorders, both in acute state (Juckel et al., 2008; Patrick et al., 2009) and in stable phase (Morosini et al., 2000; Nasrallah et al., 2008; Schaub and Juckel, 2011; Brissos et al., 2012; Wu et al., 2013). The scale showed good ability to detect changes in patient's functioning (Nasrallah et al., 2008). The PSP can be used reliably, even by staff with a low educational level and limited psychiatric professional background, after a brief training (Morosini et al., 2000). The Rehabilitation Areas (RA) form monitors the interventions in the 28 domains explored by the Functional Assessment interview. For each domain, at the beginning of the intervention and whenever changes in planning intervention are introduced, professional selects one alternative among 0 “absence of disabilities or problems”, 1 “presence of a problem: no planned intervention at present”, 2 “presence of a problem: planning intervention”, 3 “intervention in progress”, 4 “intervention concluded, problem partially/completely solved”. Data from the Rehabilitation Areas form are summarized in the Results section in terms of goals “set” and “achieved” in the 4 main areas of functioning by the CIGI users over the two-year study period. The Goal Planning (GP) form is used to develop written plans for the attainment of specific goals developed in the 28 domains examined by the Functional Assessment interview. Examples of Goal Planning form and data from Rehabilitation Areas form at baseline and at two-year follow up reassessment have been reported in Supplementary Materials.
3.1. Baseline data Most of the 114 residents were single, males, and had long duration of mental disorders and of stay in residential facilities (Table 1). Seventy and three percent had a diagnosis of schizophrenia or schizoaffective disorders, and 14.9% a personality disorder. The PSP mean score was 38.3 713.5 in the CIGI group and 35.6 714.3 in the TAU group, corresponding to “Severe difficulties in one main area and marked difficulties in at least one other main area” (10-point level: 31-40). Compared to users who received CIGI, those who received TAU had longer duration of contact with the mental health department (F¼ 6.6, df 1, 112, po 0.012), and were less frequently admitted to a psychiatric ward in the previous year (F ¼4.2, df 1, 112; p o0.05). 3.2. Provisions of the CIGI over the two-year study period In the CIGI residential facilities, 9.1 77.2 individual goals (mean 7 SD) per user were set, of which 3.6 73.2 goals were achieved over the two-year study period. In particular, 70% of the goals were in the main area of “self-care”, 22.8% were in the area of “family and social relationships”, 6.8% were in “work activities”, and 0.7% were in the area of “disturbing behaviors”. At the two-year follow up, 3.8 73.1 of the goals were ongoing. In the CIGI residential facilities, professionals held a mean number of 77.9 722.4 sessions per facility with 5.2 71.5 users per session. Of these sessions, 24% were on communication skills, whereas 50.9% were focused on the application of problem solving to “real world problems” (Table 2). In 7 out of 8 facilities, users self managed a mean of 78.1 746.6 meetings over the two year period. In one residential facility, self managed meetings were not hold due to cognitive impairment of 3 out of 4 users (medium to severe mental retardation). Most self managed meetings addressed daily activities (19.9%) and living space issues (15.7%), 9.7% focused on interests, and 8.4% on mental health topics; 19.2% had no defined/ reported topic (Table 2). 3.3. Professionals' attendance and users' voluntary participation in the CIGI training course
2.7. Statistical analyses At the baseline assessment, the CIGI and TAU groups were compared with respect to users' sociodemographic and clinical history variables by χ2 and ANOVA, as appropriate. Changes in functioning from baseline to two-year follow up reassessment in relation to the intervention were explored by performing a series of analyses of variance for repeated measures (ANOVAs). In the ANOVAs, the within subjects factor was the PSP global scores and the main areas of functioning scores at baseline and at two-year follow up, and the “between subjects” factor was the intervention (CIGI vs. TAU). In the CIGI group, ANOVA for repeated measures was performed to compare the baseline PSP score with the two-year PSP score in each diagnostic group. Statistical significance was set at p o0.05. Analyses were performed by SPSS 19.0.
Of the 31 selected CIGI professionals, 30 attended six or all training modules (96.8%), and 1 (3.2%) attended 4 training modules, due to other work commitments. Peer to peer supervision was attended by 22 (71.0%) of CIGI professionals. All 31 CIGI professionals applied the intervention for two years in the 8 participating residential facilities. Twenty and nine CIGI users attended at least one training module. In particular, 17 (58.6%) were male, had a mean age of 45.47 7.7 years, 26 (89.6%) were single, 9 (33.3%) had high school/ university degree. Twentyone (72.4%) users had a ICD10 diagnosis of schizophrenia/schizoaffective disorders, 5 (17.2%) of personality disorders, 2 (6.9%) of mood disorders, 1 (3.4%) of mental retardation. Participants had a mean duration of contact with the mental health department of 20.1 77.3 years, a mean staying in residential facilities of 6.1 73.9 years, and a PSP global score of 42.57 11.9 at baseline assessment.
3. Results
3.4. Main outcome
At baseline, all users in the 13 participating residential facilities (64 users in the 8 CIGI residential facilities and 50 users in the 5 TAU residential facilities) were assessed. CONSORT 2010 participant flow (Moher et al., 2010) is reported in Fig. 1. The two-year follow up included 96 users (84.2% of the initial sample), 55 in the CIGI group and 41 in the TAU group (Fig. 1).
The ANOVA for repeated measures showed significant differences for PSP global score (Table 3). The comparison of estimated marginal means showed significant improvement in PSP from baseline to two-year reassessment, and an higher PSP score in CIGI versus TAU group. We found a significant interaction effect between the mean scores of PSP at baseline and
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
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Fig. 1. Participant flow diagram.
follow up assessments and the intervention. In particular, the comparison of estimated marginal means showed that change in PSP global score was higher in the CIGI than in TAU group. In the CIGI group, PSP global score moved from “Severe difficulties in one main area and marked difficulties in at least one other main area” at baseline to “Marked difficulties in two or more main areas […], or severe difficulties in one main area", at two year follow up. In the TAU group, the change in the PSP global score over time was not significant, corresponding to “Severe difficulties in one main area and marked difficulties in at least one other main area”, at both assessments.
3.5. Secondary outcomes The comparison of estimated marginal mean scores of the main areas of functioning showed significant improvement in self-care, socially useful activities and disturbing behaviors from baseline to two-year reassessment, and in the self-care, family and social relationships, and disturbing behaviors main areas of functioning in CIGI versus TAU group (Table 3). A significant interaction effect between the mean scores of socially useful activities main area over time and the intervention was observed. In particular, the comparison of estimated marginal mean scores showed a significant change in socially useful activities in the CIGI group
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Fig. 2. Training course characteristics and use of the CIGI over the two-year study period.
(dysfunction moved from “Severe: the person is unable to perform any role in that area without help or has a harmful influence” at baseline to “Marked: difficulties interfering severely with role performance in that area, at two-year follow up), and no significant change in the TAU group (“Severe” dysfunction at both assessments). The effects of the CIGI in relation to diagnosis was investigated by performing single ANOVAs for repeated measures, given the low number of cases in most diagnostic groups. Statistically
significant changes in functioning from baseline to two-year follow up were observed in CIGI users with schizophrenia and schizoaffective disorders (PSP at baseline: 38.10 710.6 vs. at two-year follow up: 42.9 712.4, F¼7.0, df 1, 38; p o0.01), and in CIGI users with personality disorders, cluster B (PSP at baseline: 41.2 79.5 vs. at two-year follow up: 54.77 3.7, F¼ 16.0, df 1, 3; po 0.05). In users with schizophrenia statistically significant changes were found in the main areas of “self-care” (2.5 71.0 vs. 2.1 71.2, F¼5.1, df 1, 38; p o0.05), and of “socially useful activities” (3.6 70.8 vs.
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Table 1 Socio-demographic and clinical characteristics of the users assessed at baseline in the CIGI and the TAU groups. Variables
Sex Male Female Age, (mean 7SD) Education None Primary school Secondary school High school University Marital status Single Divorced Married Widowed Current occupation Length of staying in RF, yrs, (m 7 sd) Year in contact with MHDb, ys (m 7 sd) Hospital admissionsa in past year, (m 7 sd) Suicide attempts, yes ICD-10 diagnosis Schizophrenia and schizoaffective disorders Personality disorders, cluster A Personality disorders, cluster B Mood disorders Obsessive–compulsive disorders Mental retardation PSP global functioning score (m 7 sd)
CIGI group (N¼64)
TAU group (N¼ 50)
N
N
%
27 54.0 23 46.0 51.1 713.2
2 5 30 15 1
3.7 11.1 55.6 27.8 1.9
1 11 21 16 0
2.0 22.4 42.9 32.7 0
53 9 2 0 12 7.2 7 5.2
82.8 14.1 3.1 0 18.8
39 5 4 1 5 7.6 75.6
79.6 10.2 8.2 2.0 10.0
24.77 8.2
30.3 7 14.7
0.6 71.2
0.2 7 0.7
11
17.2
24
24.0
47
73.4
36
72.0
3 5 3 0
4.7 7.8 4.7 0
6 3 1 1
12.0 6.0 1.0 2.0
3 6.0 35.67 14.3
PSP ¼Personal and Social Performance scale; PSP score ranges from 1 to 100; higher score corresponds to better global functioning; CIGI ¼Combined Individual and Group Intervention; TAU¼ Treatment as Usual. a b
Table 2 CIGI group: sessions held by professionals and meetings self-managed by users in the residential facilities over the two-year period. Variables
Sessions hold by professionals (N ¼623)
Meetings self-managed by usersa (N¼ 547)
Mean 7 sd
Mean 7 sd
77.9 7 22.4
78.1 746.6
5.2 7 1.5
4.9 7 1.2
2.3 7 0.7
Not applicable
%
40 62.5 24 37.5 50.9 79.9
6 9.4 38.3 713.5
25
p o 0.05. p o0.01.
3.2 71.1, F¼5.5, df 1, 38; p o0.05), from baseline to two-year follow up reassessment.
4. Discussion The results of this study suggest that CIGI may improve functioning even in users with a long history of mental disorders. The study also shows that it is feasible to introduce CIGI in residential facilities by using a modular training program, open to users' voluntary participation and based on a “learn and do” approach (Johnson and Johnson, 1974; Kolb, 1984). 4.1. Limitations and strengths The meaningfulness and generalizability of the results of this study should be tempered in line with its methodological flaws. This study has a high risk of bias due to a wide range of issues, including: (a) the lack of blinding; (b) the potential reporting bias since the evaluations were performed by non independent assessors; (c) the non-random allocation of the residential facilities to CIGI or TAU group; and (d) the use of an opportunistic control group. This is the first study exploring the feasibility and effectiveness of combined individual and group rehabilitative interventions in
Sessions/meetings in each residential facility Users in each session/ meeting Professionals in each session Sessions' contents Information Communication skills Problem solving skills Real world problems Daily activities Own living space care Interests Mental health care Friendships Residential participation Self-care Social rules Housing Work Use of money Physical health care Affective life Transport Safety Education Use of telephone Not reported a
N 71 150 85 317
% 11.4 24.1 13.6 50.9 N 109 86 53 46 32 26 20 20 12 9 9 7 4 4 2 2 1 105
% 19.9 15.7 9.7 8.4 5.9 4.7 3.6 3.6 2.2 1.6 1.6 1.3 0.7 0.7 0.4 0.4 0.2 19.2
In 7 residential facilities; CIGI ¼Combined Individual and Group Intervention.
residential facilities carried out in Italy. The voluntary participation of users in the CIGI program is a strength of this study. In particular, the active involvement of users in staff training and in the self-management of some components of the intervention is in line with WHO recommendations (2010) on users' empowerment in mental health (WHO, 2010). Reassessment of functioning after two years of implementation represents a further strength of this study, since rehabilitation in users with long history of severe mental disorders and very poor levels of functional autonomy can be a slow process. Other strengths of the study are the involvement of various professionals, of which only 45% had attended rehabilitation training courses in the past, and the quite large sample enrolled. 4.2. Feasibility All 31 professionals who attended the training course implemented the CIGI in the 8 residential facilities for two years. It is likely that holding information workshops for all staff and users in each residential facility, and the most part of the course at the residential facilities may have facilitated the introduction of the CIGI in routine settings. Despite staff resistance in regard to the voluntary participation of users in the training course, 29 CIGI users attended at least one module, providing first person account of mental disorders. Users' participation in group exercises on communication and problem solving skills made role playing more realistic and closer to real life situations (WHO, 1996, 2010). In contrast to initial skepticism of the staff about the capacity of “chronic” users to provide reliable information about their own functioning and ambitions, Functioning Assessment interviews
and individual goal setting were performed with each user in the CIGI group. Professionals reported that the interviews provided them with undisclosed and unexpected information about users' histories and past abilities to be used in the process of goal negotiation and setting. 4.3. Interpretation of the results The 55 users who received the CIGI for two years showed a significant reduction of disability, mainly related to improvement in the functional area of work activities. It is likely that these successful outcomes are related to the CIGI features, working simultaneously at individual and environmental level (WHO, 1996). Social and cognitive skills learning, also useful to reach individual goals, was facilitated in CIGI group by users' attendance at professional led sessions and self-managed meetings (Johnson and Johnson, 1974; Quee et al., 2014). Participation in self-managed meetings may have prompted users' sense of self competence, connectedness (A dnøy Eriksen et al., 2014; Anthony et al., 1990) and empowerment (WHO, 2010), facilitating achievement of personal goals. In addition, users were prompted to do “homework” on communication and problem solving skills in the intervals between the professional led sessions. Such intensive social activation may have triggered the starting of a virtuous circle in professionals and users, leading to changes in the residential facilities' atmosphere (Berry et al., 2011; Falloon et al., 1984; Ljungberg et al., 2015) and resulting in high goal achievement. Since the CIGI was offered to all users in residential facilities irrespectively to diagnosis, the results of this study may be extended to a large population of users with severe mental disorders and poor functioning. However, the fact that positive outcomes have been found in users with schizophrenia/schizoaffective disorders suggests the clinical relevance of the CIGI for the treatment of these severe mental disorders (Lecomte et al., 2014). The results of this study suggest that CIGI is more effective for personal and social functioning than usual care at two-year follow up. These findings are also supported by the observed transition rates to lower intensity residential care: 30.9% in CIGI vs. 0% in TAU (χ2 ¼ 15.4, df 1, p o0.0001). The relationship between improvement in functioning in users who received the CIGI and subsequent pathways of care (i.e., number of users moving to independent home accommodation after the completion of the study) will be examined in further papers based on data routinely collected by the local Mental Health Department. Despite the methodological limitations listed above require great caution in the interpretation of the results, this study makes a useful contribution towards knowledge in the area of rehabilitation in severe mental disorders. Randomized studies are warranted to test whether the encouraging results of this study are confirmed in large samples of users with mental disorders in other residential settings.
c
b
p o 0.05. p o0.01. po 0.005.
Conflicts of interests
a
a a
PSP=Personal and Social Performance scale; PSP score ranges from 1 to 100; higher score corresponds to better global functioning; main areas of functioning score ranges from 0 to 5; lower score corresponds to lower dysfunction in the area. CIGI=Combined Individual and Group Intervention; TAU=Treatment as Usual; ANOVAs for repeated measures, comparisons based on estimated marginal means; η2 = measure of the effect size
2.4 2.2 6.50 3.61 c
2.4 7 0.1 2.8 7 0.1 3.4 7 0.1 1.0 7 0.1 2.7 7 0.1 2.8 7 0.1 3.6 7 0.1 1.3 7 0.1
5.8 0.3 6.5 4.2
b
0.06 0.003 0.06 0.04 a
2.4 7 0.1 2.6 7 0.1 3.4 7 0.1 0.9 7 0.1
2.8 7 0.1 3.0 7 0.1 3.6 7 0.1 1.4 7 0.1
4.5 9.6 3.1 4.6
a
0.05 0.09 0.03 0.05
2.6 70.1 2.7 70.1 3.6 70.1 1.0 70.1
2.17 0.2 2.5 7 0.1 3.17 0.1 1.0 7 0.1
2.8 7 0.2 2.9 7 0.1 3.6 7 0.1 1.6 7 0.2
2.8 70.2 3.0 70.1 3.6 70.1 1.1 70.2
0.03 0.02 0.06 0.04
a
4.88 0.05 35.8 72.2 34.8 7 2.0 44.0 7 1.9 38.2 71.7 0.05 a
5.3 35.3 7 1.9 41.17 1.6 0.09 c
9.6 39.9 7 1.4
η Baseline
two-year follow up
F (1,94)
η
2
CIGI
TAU
F (1,94) Mean 7SD Mean 7 SD
36.5 7 1.3
PSP global score Main areas of functioning Self-care Family and social relationships Socially useful activities Disturbing behaviors
η2 two-year follow up Baseline
two-year follow up
Baseline
TAU, mean7 SD CIGI, mean 7SD
2
Interactions Effects:Baseline and two-year follow up assessments * Intervention Between-subject factor:Intervention Within-subjects factor: Baseline and two-year follow up assessments Variables
Table 3 PSP and main areas of functioning scores at baseline and two-year follow up in the CIGI (N ¼55) and the TAU group (N ¼41).
b
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
F (1,94)
26
Prof. Lorenza Magliano received honorarium as staff trainer, within the framework of research/training agreements between “Gulliver” social cooperative of Modena, Italy and the Second University of Naples, (Agreement no. 1193/2010 Department of Experimental Medicine, Integration Agreement no. 9.9, 17/09/2012 Department of Psychology). Prof. Lorenza Magliano has financial interest as coauthor of the VADO handbook. Dr. Fabrizio Starace has received advisory panel payment by Lundbeck pharmaceutical company in the previous 36 months. Dr. Sonia Rega, Ms. Nadia Marchesini, and Dr. Marisa Rossetti reported no competing interests.
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Grant The costs of this study was covered by the annual educational plan of “Gulliver “ social cooperative of Modena, Italy (Resolution no. 2, 4/1/2011) within the framework of research/training agreements with the Second University of Naples (Agreement no. 1193/2010 Department of Experimental Medicine, Integration Agreement no. 9.9, 17/09/2012 Department of Psychology).
Acknowledgment Working Group includes the following mental health professionals: C. Adinolfi, M. Bassissi, C. Bertolini, A Bertoni, S. Biagi, E. Bioli, M. Brighenti, R. Campovecchi, S. Carafoli, R. Caselli, L. Donatelli, L. Gervasi, V. Ghezzi, P. Guaitoli, R. Laudante, C. Malorgio, S. Manzoli, R. Massa, E. Melati, A. Morritti, A. Pallari, R. Petocchi, C. Richeldi, R. Rinaldi, F. Romeo, A. Roufki, N. Scaltriti, N. Sirotti, A. Vignudini, S. Zironi. The authors thank: G. Affuso and G. Ruggiero, researchers at the Department of Psychology of the Second University of Naples (SUN) for their statistical advices in the development of the revised version of this paper; and the 114 users for their active participation in the study.
Appendix A. Supplementary material Supplementary data associated with this article can be found in the online version at http://dx.doi.org/10.1016/j.psychres.2015.12.009.
References A dnøy Eriksen, K., Arman, M., Davidson, L., Sundfør, B., Karlsson, B., 2014. Challenges in relating to mental health professionals: perspectives of persons with severe mental illness. Int. J. Ment. Health Nurs. 23, 110–117. Anthony, W., Rogers, E.S., Farkas, M., 2003. Research on evidence based practices: future directions in an era of recovery. Community Ment. Health J. 39, 101–114. Anthony, W.A., Cohen, M., Farkas, M., 1990. Psychiatric Rehabilitation. Centre for Psychiatric Rehabilitation. Boston University, Boston. Berry, K., Barrowclough, C., Haddock, G., 2011. The role of expressed emotion in relationships between psychiatric staff and people with a diagnosis of psychosis: a review of the literature. Schizophr. Bull. 37, 958–972. Bradshaw, W., 2000. Integrating cognitive-behavioral psychotherapy for person with schizophrenia into a psychiatric rehabilitation program: results of a three year trial. Community Ment. Health J. 36, 491–500. Brissos, S., Palhavã, F., Marques, J.G., Mexia, S., Carmo, A.L., Carvalho, M., Dias, C., Franco, J.D., Mendes, R., Zuzarte, P., Carita, A.I., Molodynski, A., Figueira, M.L., 2012. The Portuguese version of the Personal and Social Performance Scale (PSP): reliability, validity, and relationship with cognitive measures in hospitalized and community schizophrenia patients. Soc. Psychiatry Psychiatr. Epidemiol. 47, 1077–1086. Candini, V., Buizza, C., Ferrari, C., Caldera, M.T., Ermentini, R., Ghilardi, A., Nobili, G., Pioli, R., Sabaudo, M., Sacchetti, E., Saviotti, F.M., Seggioli, G., Zanini, A., de Girolamo, G., 2013. Is structured group psychoeducation for bipolar patients effective in ordinary mental health services? A controlled trial in Italy. J. Affect. Disord. 151, 149155. Catty, J., White, S., Koletsi, M., Becker, T., Fioritti, A., Kalkan, R., 2011. Therapeutic relationships in vocational rehabilitation: predicting good relationships for people with psychosis. Psychiatry Res. 187, 68–73. Chien, W.T., Leung, S.F., Yeung, F.K., Wong, W.K., 2013. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr. Dis. Treat. 9, 1463–1481. De Girolamo, G., Picardi, A., Micciolo, R., Falloon, I., Fioritti, A., Morosini, P.L., Group, P.R.O.G.R.E.S., 2002. Residential care in Italy. National survey of non-hospital facilities. Br. J. Psychiatry 181, 220–225. Falloon, I.R.H., Boyd, J., McGill, C., 1984. Family of Care of Schizophrenia: a problem solving approach to the treatment of mental illness. Guildford Press, London. Falloon, I.R.H., 2003. Family interventions for mental disorders: efficacy and effectiveness. World Psychiatry 2, 20–28. Garcia-Portilla, M.P., Saiz, P.A., Bousoño, M., Bascaran, M.T., Guzmán-Quilo, C., Bobes, J., 2011. Validation of the Spanish Personal and Social Performance scale (PSP) in outpatients with stable and unstable schizophrenia. Rev. De. Psiquiatr. Y. Salud Ment. 4, 918.
27
Ghadiri Vasfi, M., Moradi-Lakeh, M., Esmaeili, N., Soleimani, N., Hajebi, A., 2015. Efficacy of aftercare services for people with severe mental disorders in Iran: a randomized controlled trial. Psychiatr. Serv. 66, 373380. Gigantesco, A., Vittorielli, M., Pioli, R., Falloon, I.R., Rossi, G., Morosini, P.L., 2006. The VADO approach in psychiatric rehabilitation: a randomized controlled trial. Psychiatr. Serv. 57, 1778–1783. Gühne, U., Weinmann, S., Arnold, K., Becker, T., Riedel–Heller, S.G., 2015. S3 guideline on psychosocial therapies in severe mental illness: evidence and recommendations. Eur. Arch. Psychiatry Clin. Neurosci. 265, 173–188. Holloway, F., Carson, J., Davis, S., 2002. Rehabilitation in the United Kingdom: research, policy, and practice. Can. J. Psychiatry 47, 628634. Johnson, D.W., Johnson, R.T., 1974. Instructional goal structure: cooperative, competitive, or individualistic. Rev. Educ. Res. 44, 213–240. Juckel, G., Morosini, P.L., 2008. The new approach: psychosocial functioning as a necessary outcome criterion for therapeutic success in schizophrenia. Curr. Opin. Psychiatry 21, 630–639. Juckel, G., Schaub, D., Fuchs, N., Naumann, U., Uhl, I., Witthaus, H., Hargarter, L., Bierhoff, H.W., Brüne, M., 2008. Validation of the personal and social performance (PSP) scale in a German sample of acutely ill patients with schizophrenia. Schizophr. Res. 104, 287293. Killaspy, H., 2014. Contemporary mental health rehabilitation. East Asian Arch. Psychiatry 24, 8994. Kolb, A., 1984. Experiential Learning: Experience as the Source of Learning and Development. Prentice Hall, Englewood Cliffs (NJ). Lecomte, T., Corbière, M., Simard, S., Leclerc, C., 2014. Merging evidence-based psychosocial interventions in schizophrenia. Behav. Sci. 4, 437–447. Ljungberg, A., Denhov, A., Topor, A., 2015. The art of helpful relationships with professionals: a meta-ethnography of the perspective of persons with severe mental illness. Psychiatr. Q., Jan 29 [Epub ahead of print] Lucksted, A., McFarlane, W., Downing, D., Dixon, L., 2012. Recent developments in family psychoeducation as an evidence based practice. J. Marital. Fam. Ther. 38, 101121. Magliano, L., Fiorillo, A., Malangone, C., De Rosa, C., Maj, M., Family Intervention Working Group, 2006a. Implementing psychoeducational interventions in Italy for patients with schizophrenia and their families. Psychiatr. Serv. 57, 266–269. Magliano, L., Fiorillo, A., Malangone, C., De Rosa, C., Maj, M., 2006b. Patient functioning and family burden in a controlled, real-world trial of family psychoeducation for schizophrenia. Psychiatr. Serv. 57, 1784–1791. Magliano, L., Marasco, C., Fiorillo, A., Malangone, C., Guarneri, M., Maj, M., 2002. The impact of professional and social network support on the burden of families of patients with schizophrenia in Italy. Acta Psychiatr. Scand. 106, 291–298. Magliano, L., Fiorillo, A., 2007. Psychoeducational family interventions for schizophrenia in the last decade: from explanatory to pragmatic trials. Epidemiol. Psichiatr. Soc. 16, 2234. Marshall, M., Crowther, R., Almaraz–Serrano, A., Creed, F., Sledge, W., Kluiter, H., Roberts, C., Hill, E., Wiersma, D., Bond, G.R., Huxley, P., Tyrer, P., 2001. Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care. Health Technol. Assess. 5, 1–75. Moher, D., Hopewell, S., Schulz, K.F., Montori, V., Gotzsche, P.C., Deveraoux, P.J., Elbourne, D., Egger, M., Altman, D.G., 2010. CONSORT 2010 Explanation and elaboration: updated guidelines for reporting parallel group randomized trials. Br. Med. J. 340, c896. http://dx.doi.org/10.1136/bmj.c869. Morosini, P.L., Magliano, L., Brambilla, L., Ugolini, S., Pioli, R., 2000. Development, reliability and acceptability of a new version of the DSM IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr. Scand. 101, 323–329. Morosini, P.L., Magliano, L., Brambilla, L., 1998. VADO Valutazione di Abilità e Definizione di Obiettivi. Edizioni Erickson, Trento. Nasrallah, H., Morosini, P.L., Gagnon, D.D., 2008. Reliability, validity and ability to detect change of the personal and social performance scale in patients with stable schizophrenia. Psychiatry Res. 161, 213–224. Patrick, D.L., Burns, T., Morosini, P.L., Rothman, M., Gagnon, D.D., Wild, D., Adriaenssen, I., 2009. Reliability, validity and ability to detect change of the clinician rated personal and social performance scale in patients with acute symptoms of schizophrenia. Curr. Med. Res. Opin. 25, 325338. Pioli, R., Vittorielli, M., Gigantesco, A., Rossi, G., Basso, L., Caprioli, C., Buizza, C., Corradi, A., Mirabella, F., Morosini, P.L., Falloon, I.R., 2006. Outcome assessment of the VADO approach in psychiatric rehabilitation: a partially randomised multicentric trial. Clin. Pract. Epidemiol. Ment. Health 3, 2–5. Quee, P.J., Stiekema, A.P.M., Wigman, J.T.W., Schneider, H., van der Meer, L., Maples, N.J., van den Heuvel, E.R., Velligan, D.I., Bruggeman, R., 2014. Improving functional outcomes for schizophrenia patients in the Netherlands using cognitive adaptation training as a nursing intervention a pilot study. Schizophr. Res. 158, 1205. Santone, G., de Girolamo, G., Falloon, I., Fioritti, A., Micciolo, R., Picardi, A., Zanalda, E., PROGRES Group, 2005. The process of care in residential facilities—a national survey in Italy. Soc. Psychiatry Psychiatr. Epidemiol. 40, 540–550. Schaub, D., Juckel, G., 2011. PSP scale: German version of the personal and social performance scale: valid instrument for the assessment of psychosocial functioning in the treatment of schizophrenia. Nervenarzt 82, 11781184. Srisurapanont, M., Arunpongpaisal, S., Chuntaruchikapong, S., Silpakit, C., Khuangsirikul, V., Karnjanathanalers, N., Samanwongthai, U., 2008. Cross cultural validation and inter rater reliability of the personal and social performance scale, Thai version. J. Med. Assoc. Thai 91, 16031608.
28
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Stiekema, A.P., Quee, P.J., Dethmers, M., van den Heuvel, E.R., Redmeijer, J.E., Rietberg, K., Stant, A.D., Swart, M., van Weeghel, J., Aleman, A., Velligan, D.I., Schoevers, R.A., Bruggeman, R., van der Meer, L., 2015. Effectiveness and costeffectiveness of cognitive adaptation training as a nursing intervention in longterm residential patients with severe mental illness: study protocol for a randomized controlled trial. Trials 16, 49. http://dx.doi.org/10.1186/ s1306301505668. Velligan, D.I., Diamond, P.M., Maples, N.J., Mintz, J., Li, X., Glahn, D.C., Miller, A.L., 2008. Comparing the efficacy of interventions that use environmental supports to improve outcomes in patients with schizophrenia. Schizophr. Res. 102, 312319. Vittorielli, M., Pioli, R., Brambilla, L., Archiati, L., Rossi, G., Sleijpen, C., Magliano, L., Veltro, F., Morosini, P.L., 2003. Efficacy of the “VADO” approach in psychiatric rehabilitation: a controlled study. Epidemiol. Psichiatr. Soc. 12, 43–52.
World Health Organisation (WHO), Regional Office for Europe, 2010. User empowerment in mental health: a statement by the WHO Regional Office for Europe 〈www.euro.who.int/__data/assets/pdf_file/0020/113834/E93430.pdf〉. World Health Organisation (WHO), World Association for Psychosocial Rehabilitation (WAPR), 1996. Psychosocial Rehabilitation Consensus Statement 〈http:// www.wapr.info/World_Association_for_Psychosocial_Rehabilitation_WAPR/ Documents_files/WHO_WAPR_ConsensusStatement_96.pdf〉. Wu, B.J., Lin, C.H., Tseng, H.F., Liu, W.M., Chen, W.C., Huang, L.S., Sun, H.J., Chiang, S. K., Lee, S.M., 2013. Validation of the Taiwanese Mandarin version of the personal and social performance scale in a sample of 655 stable schizophrenic patients. Schizophr. Res. 146, 3439.
Contents lists available at ScienceDirect
Psychiatry Research journal homepage: www.elsevier.com/locate/psychres
Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study Lorenza Magliano a,n, Marta Puviani b, Sonia Rega c, Nadia Marchesini d, Marisa Rossetti d, Fabrizio Starace d, the Working Group a
Department of Psychology, Second University of Naples, Viale Ellittico 31, 81100 Caserta, Italy “Gulliver” Social Cooperative, Modena, Italy “Aliante” Social Cooperative, Modena, Italy d Mental Health Department of Modena, Italy b c
art ic l e i nf o
a b s t r a c t
Article history: Received 16 July 2015 Received in revised form 23 October 2015 Accepted 8 December 2015 Available online 11 December 2015
This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. & 2016 Published by Elsevier Ireland Ltd.
Keywords: Psychosocial rehabilitation Residential facilities Mental disorders Staff training Psychoeducation Controlled study
1. Introduction Psychosocial rehabilitation is an essential ingredient of care for people with severe and long term mental disorders (Anthony et al., 1990; WHO, 1996; Holloway et al., 2002; Anthony et al., 2003; Juckel and Morosini, 2008). Although many evidence-based rehabilitative interventions exist (Bradshaw, 2000; Marshall et al., 2001; Lucksted et al., 2012; Chien et al., 2013, Gühne et al., 2015), most of them are rarely available in routine settings, even in countries with long experience of community care such as Italy. A study of a representative sample of Italian mental health services (Magliano et al., 2002) revealed that only 35% of users with schizophrenia living in family received rehabilitative interventions, and that such interventions included the setting of personalized goals in 66% of cases, while only 8% of users' families received psychoeducational support. The availability of psychosocial interventions is even scarcer in n
Corresponding author. E-mail address: [email protected] (L. Magliano).
http://dx.doi.org/10.1016/j.psychres.2015.12.009 0165-1781/& 2016 Published by Elsevier Ireland Ltd.
psychiatric residential facilities, where users with poor levels of independent life skills and social resources are housed (De Girolamo et al., 2002; Killaspy, 2014; Stiekema et al., 2015). A survey on the process of care in 265 Italian residential facilities (Santone et al., 2005) found that a standardized assessment was performed in 38% of cases; an individual rehabilitation program was planned in 74% of cases; users were actively involved in written treatment plans in 35% of cases. Staff pessimism regarding the capacities of “chronic” users to successfully attend intensive rehabilitative programs may, in part, explain low turnover rates and the poor provision of structured interventions found in residential facilities. Although a homelike atmosphere was found in many Italian residential facilities, most of them had restrictive rules regarding patients' daily lives and behaviors, which may represent further obstacles to their acquisition of functional autonomy. In many circumstances, residential facilities represent “houses for life” (de Girolamo et al., 2002), where residents become cohabitants related to each other by affective relationships, and have daily contact with staff for years (Ljungberg et al., 2015). Although staff members may have less emotional investment in relationships with residents than relatives do, associations have been found
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between the quality of staff–resident relationships and residents' discharge rates (Berry et al., 2011). Therefore, the quality of therapeutic relationships between residents and staff is of central importance in residential facilities and may constitute a key resource for achieving favorable outcomes in severe mental disorders (Berry et al., 2011; Catty et al., 2011; Ghadiri Vasfi et al., 2015). Regrettably, as reported in a national survey of 1370 nonhospital residential facilities in Italy (de Girolamo et al., 2002), approximately 40% of residential facilities' staff had no specific professional qualification for working with people with severe psychiatric conditions. Literature data shows that it is possible to introduce evidencebased psychosocial interventions in mental health services after a relatively brief staff training (Magliano et al., 2006a; Quee et al., 2014; Stiekema et al., 2015), and that psychosocial interventions may improve functional outcomes of mental disorders when provided in routine settings (Falloon, 2003; Magliano and Fiorillo, 2007; Candini et al., 2013; Ghadiri Vasfi et al., 2015). For instance, a study carried out in 23 Italian mental health services on the implementation and effectiveness of family psychoeducational intervention for schizophrenia (Magliano et al., 2006a, b) found that this intervention, when provided by trained staff, led to significant improvement in patients' functioning at six-month follow up, particularly in social relationships, job interests, and management of social conflicts (Magliano et al., 2006b). Despite the above reported findings, no study has systematically evaluated the effects of psychoeducational group treatments when provided in residential facilities. Furthermore, when structured rehabilitative interventions were provided to users with schizophrenia attending day centers and residential facilities, significant improvement of functioning was achieved (Vittorielli et al., 2003; Gigantesco et al., 2006; Pioli et al., 2006; Velligan et al., 2008; Quee et al. 2014). A randomized controlled trial testing the effectiveness of an individualized cognitive-behavioral approach called VADO (Valutazione di Abilità e Definizione di Obiettivi; in English, Skills Assessment and Definition of Goals; Morosini et al., 1998) on functioning of users with long-term schizophrenia who attended day centers and residential facilities (Gigantesco et al., 2006) reported marked functioning improvement in the VADO group, and minimal changes in controls at six and twelve-month follow up. At twelve-month follow up, the difference in functioning level between the VADO and the control group was both statistically and clinically significant. Taking into account the above-mentioned findings, we developed a rehabilitation program Combining Individual VADO intervention (Morosini et al., 1998) with Falloon's psychoeducational Group Intervention (CIGI) (Falloon et al., 1984) to be introduced in psychiatric residential facilities. The program, in alignment with the World Health Organization's (WHO) psychosocial rehabilitation statement (1996), aimed to both improve competencies of users and introduce environmental changes in residential facilities. Moreover, in order to promote users' empowerment (WHO, 2010), the program was open to patients' voluntary participation in staff training and self-management of several psychoeducational group components. The program was applied from June 2011 to May 2013 in 8 residential facilities of the Department of Mental Health of Modena, Italy, as part of the annual staff training plan. In the same department, further 5 residential facilities not involved in the CIGI program, were used as Treatment-As-Usual (TAU) controls. This study aimed to explore the feasibility of introducing the CIGI in residential facilities and to verify whether, at two-year follow up, users who received the CIGI had better global functioning than those who received the TAU. The study questions were the following:
(a) Is it possible to train residential facilities' staff in a complex rehabilitative intervention, combining an individual evidencebased treatment with a group evidence-based treatment? (b) Are users living in residential facilities able to actively participate in the CIGI training and self-manage some aspects of this intervention? (c) Is the CIGI more effective than the TAU to improve users functioning at two-year follow up?
2. Methods 2.1. Design of the study This was a controlled, non-randomized study carried out from June 2011 to May 2013 in 13 residential facilities of the Department of Mental Health of Modena, Italy. The 13 residential facilities were managed by 3 social cooperatives that committed the study, in collaboration with the Mental Health Department of Modena, as part of the annual training plan for the staff. Therefore, key decision regarding the facilities' selection was taken by the commitments.The study was approved by the Ethics Committee of the Local Health Unit of Modena (No. 155/2011) and carried out in collaboration with the Department of Psychology of the Second University of Naples (SUN), Italy. 2.1.1. Participating sites Of the 13 residential facilities involved in the study, the 8 facilities located in the Central district of the Mental Health Department of Modena were selected to introduce the CIGI (CIGI residential facilities), while the 5 residential facilities located in the Northern and in the Southern district were used as TAU controls (TAU residential facilities). Two (25%) CIGI residential facilities and 2 (40%) TAU residential facilities had staff for 24 h a day, while 6 (75%) CIGI facilities and 3 (60%) TAU facilities had staff for r12 hour a day. 2.1.2. Eligible cases All users living in the 13 residential facilities were considered as eligible for the study. Informed consent for the collection and use of personal data for research purposes was obtained from each user and professional involved in the study. 2.2. Interventions 2.2.1. Combined Individual and Group Intervention (CIGI) The CIGI included an Individual component, the VADO approach (Valutazione di Abilità e Definizione di Obiettivi; in English, Skills Assessment and Definition of Goals), and a Group component, the Falloon's psychoeducational approach. The VADO approach (Morosini et al., 1998) is a manualized, cognitive-behavioral intervention described in a handbook also including several assessment instruments. The VADO, developed in line with WHO psychosocial rehabilitation principles (WHO, 1996) and inspired by the Boston Rehabilitation Center's approach (Anthony et al., 1990), is based on: (a) the assessment of the user's capacities and disabilities, performed by using the VADO's Functioning Assessment interview and the Personal and Social Performance (PSP) scale; (b) the negotiation with the user of realistic goals achievable in 3– 6 months, each planned by using the VADO's Goal Plan form; and (c) the evaluation of progress towards achievement of each planned goal, monitored by using the VADO's Rehabilitative Areas form (in “Description of the Instruments”). In the CIGI, the VADO approach was used to develop individual rehabilitation plans to be revised by the staff with each user, weekly over the study period. The Falloon's psychoeducational approach (Falloon et al., 1984;
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Falloon, 2003) is a well known cognitive-behavioral family intervention. Its basic components are: (a) the assessment of individual and family needs; (b) information sessions about mental disorders, their treatments, and relapse prevention, in which patients are considered experts of their own mental disorders; (c,d) communication and problem solving skills training based on sessions with therapists and relatives' self-managed meetings (without therapists); and (e) exercises to facilitate skills generalization. In the CIGI, the psychoeducational approach was applied with the users as a group. Over the two year study period, professionals held weekly group sessions on psychoeducational components and prompted the users to hold self managed weekly meetings (without professionals) “as if they were family members”, and to do group exercises (Fig. 2). 2.2.2. Treatment-As-Usual (TAU) The TAU was the routine rehabilitation approach used in the other 5 residential facilities. TAU included individual programs developed by the staff for each user, and group activities planned by the staff for all users. The individual programs consisted in staff support to users in performing self-care and care of personal life environment activities, in managing money and using public transports, and in limiting the adoption of at risk health behaviors (i.e., smoking, abuse of alcohol and coffee). Individual programs were not based on negotiation and setting of written individual goals with each user, and they did not include time defined goals. The individual programs were updated yearly by the staff without involving the users. In the TAU residential facilities, users were expected to collaborate in housework activities according to shifts defined by the staff (cleaning the house, tidying things up, cooking), and to participate in several group activities with rehabilitative potentialities, such as art laboratories, parties, excursions and supported holidays.
21
module, techniques were revised and difficulties encountered in real world situations were addressed using a problem solving approach. During the year following the course, trainees attended five peer to peer 3 h supervision meetings to share their experiences. In the first module, the 31 selected CIGI professionals were trained in the use of the VADO's Functioning Assessment interview, Personal and Social Performance assessment scale (PSP), Rehabilitation Areas form and Goal Planning form. In the interval between the first and the second module, the CIGI professionals were invited to held a workshop in each CIGI residential facility aimed to: (a) inform all staff and users about the CIGI; (b) invite users to voluntarily participate in the subsequent training modules; and (c) request informed consent to each user. In the same interval, the CIGI professionals were asked to administer the Functioning Assessment interview and the Personal and Social Performance assessment scale (PSP) to each resident staying in the 8 participating facilities at that time, and to set at least one goal with each resident using the VADO planning tools. In the subsequent modules, users who voluntary attended the training course were involved in plenary sessions and working group exercises with the staff. The characteristics of the CIGI training, developed in line with WHO recommendations to promote users' empowerment in mental health (WHO, 2010), are summarized in Fig. 2. 2.4. Outcomes The primary outcome of the study was the improvement in users' functioning, assessed in terms of increase in global score on the Personal and Social Performance scale (PSP). The secondary study outcomes were the reduction of users' disability in the main areas of functioning, as assessed by the Functioning Assessment interview, and the increase in PSP global score for each diagnosis in the CIGI group.
2.3. Training in the CIGI 2.5. Assessment procedures 2.3.1. Participating staff Among all stable staff with permanent employment contract working in the 8 CIGI residential facilities (N ¼ 58), the following professionals were selected to attend the CIGI training course: the psychiatrists (4/31, 12.9%) and the nurses (3/31, 9.7) of the mental health department providing clinical care in the CIGI facilities; the Coordinators (8/31, 25.8%) of each residential facility; all rehabilitators/educators (9, 29.0%), and healthcare assistants (6, 19.3%) directly involved in the development of individual rehabilitative plans. One clinical psychologist attending his post degree training in one of the CIGI residential facilities was also accepted as participant (3.2%). The 31 selected professionals had a mean age of 38.9 79.3(SD) years, 23 (74.2%) were females, 19 (61.3%) were single and 19 (61.3%) were highly educated. Participants had worked in the mental health field for 11.8 78.9 (SD) years on average, and 14 (45.2%) had attended rehabilitation training courses in the past.
At baseline and again at two years from the start of the training course, the Functioning Assessment interview, and the PSP were administered to each resident staying in the 13 participating residential facilities at that time by trained professionals. In the 8 CIGI residential facilities, the assessments were performed by the staff as part of the CIGI package, while in 5 TAU residential facilities, the assessments were performed by the professionals who provided TAU and who had been previously trained in the use of the VADO's Functioning Assessment interview and Personal and Social Performance scale. Over the two year study period, in the CIGI residential facilities the following were registered: (a) the number and type of goals set and achieved by each user; (b) the number and content of group sessions held by professionals; and (c) the number and content of users' self managed meetings. 2.6. Description of Instruments
2.3.2. Training course procedures The training course consisted of five 1.5 day modules (12 h each) with a 30–45 day interval between each one, followed by two one day modules (8 h each), held for the most part at participating residential facilities. In the modules, the VADO techniques and the psychoeducational group techniques were addressed. Guidelines, working group exercises, and ad hoc role- play scenarios developed by a researcher of the Second University of Naples, Italy (L.M.) were used. In line with a “learn and do” approach (Johnson and Johnson, 1974; Kolb, 1984), participants were asked to apply the techniques at the residential facilities immediately after each one was addressed in each module. In each subsequent
The Functioning Assessment interview is a semi-structured interview exploring the user's capabilities and difficulties in 28 functional domains in the past month (described in Gigantesco et al., 2006). Domains are grouped in four main areas of functioning: self-care; socially useful activities, including work and study; social and family relationships; and disturbing behaviors. Each area is rated on a 6-level scale, from 0, “no dysfunction,” to 5, “very severe dysfunction,” using operational criteria (reported in Morosini et al., 2000). The Personal and Social Performance (PSP) scale provides a functioning global score computed on the basis of the main area
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scores explored by the Functioning Assessment interview. The PSP global score ranges from 100, “excellent functioning,” to 1, “extremely severe impairment.” Scores are grouped into ten 10-point levels on the basis of degree of difficulties and number of main areas in which difficulties have been observed. The PSP has been originally developed in Italian as part of the VADO manual (Morosini et al., 1998) and then validated in a sample of patients housed in residential facilities (Morosini et al., 2000). Subsequently, the PSP has been translated and validated in several other languages (Brisson et al., 2008; Srisurapanont et al., 2008; Garcia-Portilla et al., 2011; Wu et al., 2013). The PSP's psychometric properties have been repeatedly tested and found satisfactory in sample of patients with severe mental disorders, both in acute state (Juckel et al., 2008; Patrick et al., 2009) and in stable phase (Morosini et al., 2000; Nasrallah et al., 2008; Schaub and Juckel, 2011; Brissos et al., 2012; Wu et al., 2013). The scale showed good ability to detect changes in patient's functioning (Nasrallah et al., 2008). The PSP can be used reliably, even by staff with a low educational level and limited psychiatric professional background, after a brief training (Morosini et al., 2000). The Rehabilitation Areas (RA) form monitors the interventions in the 28 domains explored by the Functional Assessment interview. For each domain, at the beginning of the intervention and whenever changes in planning intervention are introduced, professional selects one alternative among 0 “absence of disabilities or problems”, 1 “presence of a problem: no planned intervention at present”, 2 “presence of a problem: planning intervention”, 3 “intervention in progress”, 4 “intervention concluded, problem partially/completely solved”. Data from the Rehabilitation Areas form are summarized in the Results section in terms of goals “set” and “achieved” in the 4 main areas of functioning by the CIGI users over the two-year study period. The Goal Planning (GP) form is used to develop written plans for the attainment of specific goals developed in the 28 domains examined by the Functional Assessment interview. Examples of Goal Planning form and data from Rehabilitation Areas form at baseline and at two-year follow up reassessment have been reported in Supplementary Materials.
3.1. Baseline data Most of the 114 residents were single, males, and had long duration of mental disorders and of stay in residential facilities (Table 1). Seventy and three percent had a diagnosis of schizophrenia or schizoaffective disorders, and 14.9% a personality disorder. The PSP mean score was 38.3 713.5 in the CIGI group and 35.6 714.3 in the TAU group, corresponding to “Severe difficulties in one main area and marked difficulties in at least one other main area” (10-point level: 31-40). Compared to users who received CIGI, those who received TAU had longer duration of contact with the mental health department (F¼ 6.6, df 1, 112, po 0.012), and were less frequently admitted to a psychiatric ward in the previous year (F ¼4.2, df 1, 112; p o0.05). 3.2. Provisions of the CIGI over the two-year study period In the CIGI residential facilities, 9.1 77.2 individual goals (mean 7 SD) per user were set, of which 3.6 73.2 goals were achieved over the two-year study period. In particular, 70% of the goals were in the main area of “self-care”, 22.8% were in the area of “family and social relationships”, 6.8% were in “work activities”, and 0.7% were in the area of “disturbing behaviors”. At the two-year follow up, 3.8 73.1 of the goals were ongoing. In the CIGI residential facilities, professionals held a mean number of 77.9 722.4 sessions per facility with 5.2 71.5 users per session. Of these sessions, 24% were on communication skills, whereas 50.9% were focused on the application of problem solving to “real world problems” (Table 2). In 7 out of 8 facilities, users self managed a mean of 78.1 746.6 meetings over the two year period. In one residential facility, self managed meetings were not hold due to cognitive impairment of 3 out of 4 users (medium to severe mental retardation). Most self managed meetings addressed daily activities (19.9%) and living space issues (15.7%), 9.7% focused on interests, and 8.4% on mental health topics; 19.2% had no defined/ reported topic (Table 2). 3.3. Professionals' attendance and users' voluntary participation in the CIGI training course
2.7. Statistical analyses At the baseline assessment, the CIGI and TAU groups were compared with respect to users' sociodemographic and clinical history variables by χ2 and ANOVA, as appropriate. Changes in functioning from baseline to two-year follow up reassessment in relation to the intervention were explored by performing a series of analyses of variance for repeated measures (ANOVAs). In the ANOVAs, the within subjects factor was the PSP global scores and the main areas of functioning scores at baseline and at two-year follow up, and the “between subjects” factor was the intervention (CIGI vs. TAU). In the CIGI group, ANOVA for repeated measures was performed to compare the baseline PSP score with the two-year PSP score in each diagnostic group. Statistical significance was set at p o0.05. Analyses were performed by SPSS 19.0.
Of the 31 selected CIGI professionals, 30 attended six or all training modules (96.8%), and 1 (3.2%) attended 4 training modules, due to other work commitments. Peer to peer supervision was attended by 22 (71.0%) of CIGI professionals. All 31 CIGI professionals applied the intervention for two years in the 8 participating residential facilities. Twenty and nine CIGI users attended at least one training module. In particular, 17 (58.6%) were male, had a mean age of 45.47 7.7 years, 26 (89.6%) were single, 9 (33.3%) had high school/ university degree. Twentyone (72.4%) users had a ICD10 diagnosis of schizophrenia/schizoaffective disorders, 5 (17.2%) of personality disorders, 2 (6.9%) of mood disorders, 1 (3.4%) of mental retardation. Participants had a mean duration of contact with the mental health department of 20.1 77.3 years, a mean staying in residential facilities of 6.1 73.9 years, and a PSP global score of 42.57 11.9 at baseline assessment.
3. Results
3.4. Main outcome
At baseline, all users in the 13 participating residential facilities (64 users in the 8 CIGI residential facilities and 50 users in the 5 TAU residential facilities) were assessed. CONSORT 2010 participant flow (Moher et al., 2010) is reported in Fig. 1. The two-year follow up included 96 users (84.2% of the initial sample), 55 in the CIGI group and 41 in the TAU group (Fig. 1).
The ANOVA for repeated measures showed significant differences for PSP global score (Table 3). The comparison of estimated marginal means showed significant improvement in PSP from baseline to two-year reassessment, and an higher PSP score in CIGI versus TAU group. We found a significant interaction effect between the mean scores of PSP at baseline and
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
23
Fig. 1. Participant flow diagram.
follow up assessments and the intervention. In particular, the comparison of estimated marginal means showed that change in PSP global score was higher in the CIGI than in TAU group. In the CIGI group, PSP global score moved from “Severe difficulties in one main area and marked difficulties in at least one other main area” at baseline to “Marked difficulties in two or more main areas […], or severe difficulties in one main area", at two year follow up. In the TAU group, the change in the PSP global score over time was not significant, corresponding to “Severe difficulties in one main area and marked difficulties in at least one other main area”, at both assessments.
3.5. Secondary outcomes The comparison of estimated marginal mean scores of the main areas of functioning showed significant improvement in self-care, socially useful activities and disturbing behaviors from baseline to two-year reassessment, and in the self-care, family and social relationships, and disturbing behaviors main areas of functioning in CIGI versus TAU group (Table 3). A significant interaction effect between the mean scores of socially useful activities main area over time and the intervention was observed. In particular, the comparison of estimated marginal mean scores showed a significant change in socially useful activities in the CIGI group
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L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Fig. 2. Training course characteristics and use of the CIGI over the two-year study period.
(dysfunction moved from “Severe: the person is unable to perform any role in that area without help or has a harmful influence” at baseline to “Marked: difficulties interfering severely with role performance in that area, at two-year follow up), and no significant change in the TAU group (“Severe” dysfunction at both assessments). The effects of the CIGI in relation to diagnosis was investigated by performing single ANOVAs for repeated measures, given the low number of cases in most diagnostic groups. Statistically
significant changes in functioning from baseline to two-year follow up were observed in CIGI users with schizophrenia and schizoaffective disorders (PSP at baseline: 38.10 710.6 vs. at two-year follow up: 42.9 712.4, F¼7.0, df 1, 38; p o0.01), and in CIGI users with personality disorders, cluster B (PSP at baseline: 41.2 79.5 vs. at two-year follow up: 54.77 3.7, F¼ 16.0, df 1, 3; po 0.05). In users with schizophrenia statistically significant changes were found in the main areas of “self-care” (2.5 71.0 vs. 2.1 71.2, F¼5.1, df 1, 38; p o0.05), and of “socially useful activities” (3.6 70.8 vs.
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Table 1 Socio-demographic and clinical characteristics of the users assessed at baseline in the CIGI and the TAU groups. Variables
Sex Male Female Age, (mean 7SD) Education None Primary school Secondary school High school University Marital status Single Divorced Married Widowed Current occupation Length of staying in RF, yrs, (m 7 sd) Year in contact with MHDb, ys (m 7 sd) Hospital admissionsa in past year, (m 7 sd) Suicide attempts, yes ICD-10 diagnosis Schizophrenia and schizoaffective disorders Personality disorders, cluster A Personality disorders, cluster B Mood disorders Obsessive–compulsive disorders Mental retardation PSP global functioning score (m 7 sd)
CIGI group (N¼64)
TAU group (N¼ 50)
N
N
%
27 54.0 23 46.0 51.1 713.2
2 5 30 15 1
3.7 11.1 55.6 27.8 1.9
1 11 21 16 0
2.0 22.4 42.9 32.7 0
53 9 2 0 12 7.2 7 5.2
82.8 14.1 3.1 0 18.8
39 5 4 1 5 7.6 75.6
79.6 10.2 8.2 2.0 10.0
24.77 8.2
30.3 7 14.7
0.6 71.2
0.2 7 0.7
11
17.2
24
24.0
47
73.4
36
72.0
3 5 3 0
4.7 7.8 4.7 0
6 3 1 1
12.0 6.0 1.0 2.0
3 6.0 35.67 14.3
PSP ¼Personal and Social Performance scale; PSP score ranges from 1 to 100; higher score corresponds to better global functioning; CIGI ¼Combined Individual and Group Intervention; TAU¼ Treatment as Usual. a b
Table 2 CIGI group: sessions held by professionals and meetings self-managed by users in the residential facilities over the two-year period. Variables
Sessions hold by professionals (N ¼623)
Meetings self-managed by usersa (N¼ 547)
Mean 7 sd
Mean 7 sd
77.9 7 22.4
78.1 746.6
5.2 7 1.5
4.9 7 1.2
2.3 7 0.7
Not applicable
%
40 62.5 24 37.5 50.9 79.9
6 9.4 38.3 713.5
25
p o 0.05. p o0.01.
3.2 71.1, F¼5.5, df 1, 38; p o0.05), from baseline to two-year follow up reassessment.
4. Discussion The results of this study suggest that CIGI may improve functioning even in users with a long history of mental disorders. The study also shows that it is feasible to introduce CIGI in residential facilities by using a modular training program, open to users' voluntary participation and based on a “learn and do” approach (Johnson and Johnson, 1974; Kolb, 1984). 4.1. Limitations and strengths The meaningfulness and generalizability of the results of this study should be tempered in line with its methodological flaws. This study has a high risk of bias due to a wide range of issues, including: (a) the lack of blinding; (b) the potential reporting bias since the evaluations were performed by non independent assessors; (c) the non-random allocation of the residential facilities to CIGI or TAU group; and (d) the use of an opportunistic control group. This is the first study exploring the feasibility and effectiveness of combined individual and group rehabilitative interventions in
Sessions/meetings in each residential facility Users in each session/ meeting Professionals in each session Sessions' contents Information Communication skills Problem solving skills Real world problems Daily activities Own living space care Interests Mental health care Friendships Residential participation Self-care Social rules Housing Work Use of money Physical health care Affective life Transport Safety Education Use of telephone Not reported a
N 71 150 85 317
% 11.4 24.1 13.6 50.9 N 109 86 53 46 32 26 20 20 12 9 9 7 4 4 2 2 1 105
% 19.9 15.7 9.7 8.4 5.9 4.7 3.6 3.6 2.2 1.6 1.6 1.3 0.7 0.7 0.4 0.4 0.2 19.2
In 7 residential facilities; CIGI ¼Combined Individual and Group Intervention.
residential facilities carried out in Italy. The voluntary participation of users in the CIGI program is a strength of this study. In particular, the active involvement of users in staff training and in the self-management of some components of the intervention is in line with WHO recommendations (2010) on users' empowerment in mental health (WHO, 2010). Reassessment of functioning after two years of implementation represents a further strength of this study, since rehabilitation in users with long history of severe mental disorders and very poor levels of functional autonomy can be a slow process. Other strengths of the study are the involvement of various professionals, of which only 45% had attended rehabilitation training courses in the past, and the quite large sample enrolled. 4.2. Feasibility All 31 professionals who attended the training course implemented the CIGI in the 8 residential facilities for two years. It is likely that holding information workshops for all staff and users in each residential facility, and the most part of the course at the residential facilities may have facilitated the introduction of the CIGI in routine settings. Despite staff resistance in regard to the voluntary participation of users in the training course, 29 CIGI users attended at least one module, providing first person account of mental disorders. Users' participation in group exercises on communication and problem solving skills made role playing more realistic and closer to real life situations (WHO, 1996, 2010). In contrast to initial skepticism of the staff about the capacity of “chronic” users to provide reliable information about their own functioning and ambitions, Functioning Assessment interviews
and individual goal setting were performed with each user in the CIGI group. Professionals reported that the interviews provided them with undisclosed and unexpected information about users' histories and past abilities to be used in the process of goal negotiation and setting. 4.3. Interpretation of the results The 55 users who received the CIGI for two years showed a significant reduction of disability, mainly related to improvement in the functional area of work activities. It is likely that these successful outcomes are related to the CIGI features, working simultaneously at individual and environmental level (WHO, 1996). Social and cognitive skills learning, also useful to reach individual goals, was facilitated in CIGI group by users' attendance at professional led sessions and self-managed meetings (Johnson and Johnson, 1974; Quee et al., 2014). Participation in self-managed meetings may have prompted users' sense of self competence, connectedness (A dnøy Eriksen et al., 2014; Anthony et al., 1990) and empowerment (WHO, 2010), facilitating achievement of personal goals. In addition, users were prompted to do “homework” on communication and problem solving skills in the intervals between the professional led sessions. Such intensive social activation may have triggered the starting of a virtuous circle in professionals and users, leading to changes in the residential facilities' atmosphere (Berry et al., 2011; Falloon et al., 1984; Ljungberg et al., 2015) and resulting in high goal achievement. Since the CIGI was offered to all users in residential facilities irrespectively to diagnosis, the results of this study may be extended to a large population of users with severe mental disorders and poor functioning. However, the fact that positive outcomes have been found in users with schizophrenia/schizoaffective disorders suggests the clinical relevance of the CIGI for the treatment of these severe mental disorders (Lecomte et al., 2014). The results of this study suggest that CIGI is more effective for personal and social functioning than usual care at two-year follow up. These findings are also supported by the observed transition rates to lower intensity residential care: 30.9% in CIGI vs. 0% in TAU (χ2 ¼ 15.4, df 1, p o0.0001). The relationship between improvement in functioning in users who received the CIGI and subsequent pathways of care (i.e., number of users moving to independent home accommodation after the completion of the study) will be examined in further papers based on data routinely collected by the local Mental Health Department. Despite the methodological limitations listed above require great caution in the interpretation of the results, this study makes a useful contribution towards knowledge in the area of rehabilitation in severe mental disorders. Randomized studies are warranted to test whether the encouraging results of this study are confirmed in large samples of users with mental disorders in other residential settings.
c
b
p o 0.05. p o0.01. po 0.005.
Conflicts of interests
a
a a
PSP=Personal and Social Performance scale; PSP score ranges from 1 to 100; higher score corresponds to better global functioning; main areas of functioning score ranges from 0 to 5; lower score corresponds to lower dysfunction in the area. CIGI=Combined Individual and Group Intervention; TAU=Treatment as Usual; ANOVAs for repeated measures, comparisons based on estimated marginal means; η2 = measure of the effect size
2.4 2.2 6.50 3.61 c
2.4 7 0.1 2.8 7 0.1 3.4 7 0.1 1.0 7 0.1 2.7 7 0.1 2.8 7 0.1 3.6 7 0.1 1.3 7 0.1
5.8 0.3 6.5 4.2
b
0.06 0.003 0.06 0.04 a
2.4 7 0.1 2.6 7 0.1 3.4 7 0.1 0.9 7 0.1
2.8 7 0.1 3.0 7 0.1 3.6 7 0.1 1.4 7 0.1
4.5 9.6 3.1 4.6
a
0.05 0.09 0.03 0.05
2.6 70.1 2.7 70.1 3.6 70.1 1.0 70.1
2.17 0.2 2.5 7 0.1 3.17 0.1 1.0 7 0.1
2.8 7 0.2 2.9 7 0.1 3.6 7 0.1 1.6 7 0.2
2.8 70.2 3.0 70.1 3.6 70.1 1.1 70.2
0.03 0.02 0.06 0.04
a
4.88 0.05 35.8 72.2 34.8 7 2.0 44.0 7 1.9 38.2 71.7 0.05 a
5.3 35.3 7 1.9 41.17 1.6 0.09 c
9.6 39.9 7 1.4
η Baseline
two-year follow up
F (1,94)
η
2
CIGI
TAU
F (1,94) Mean 7SD Mean 7 SD
36.5 7 1.3
PSP global score Main areas of functioning Self-care Family and social relationships Socially useful activities Disturbing behaviors
η2 two-year follow up Baseline
two-year follow up
Baseline
TAU, mean7 SD CIGI, mean 7SD
2
Interactions Effects:Baseline and two-year follow up assessments * Intervention Between-subject factor:Intervention Within-subjects factor: Baseline and two-year follow up assessments Variables
Table 3 PSP and main areas of functioning scores at baseline and two-year follow up in the CIGI (N ¼55) and the TAU group (N ¼41).
b
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
F (1,94)
26
Prof. Lorenza Magliano received honorarium as staff trainer, within the framework of research/training agreements between “Gulliver” social cooperative of Modena, Italy and the Second University of Naples, (Agreement no. 1193/2010 Department of Experimental Medicine, Integration Agreement no. 9.9, 17/09/2012 Department of Psychology). Prof. Lorenza Magliano has financial interest as coauthor of the VADO handbook. Dr. Fabrizio Starace has received advisory panel payment by Lundbeck pharmaceutical company in the previous 36 months. Dr. Sonia Rega, Ms. Nadia Marchesini, and Dr. Marisa Rossetti reported no competing interests.
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Grant The costs of this study was covered by the annual educational plan of “Gulliver “ social cooperative of Modena, Italy (Resolution no. 2, 4/1/2011) within the framework of research/training agreements with the Second University of Naples (Agreement no. 1193/2010 Department of Experimental Medicine, Integration Agreement no. 9.9, 17/09/2012 Department of Psychology).
Acknowledgment Working Group includes the following mental health professionals: C. Adinolfi, M. Bassissi, C. Bertolini, A Bertoni, S. Biagi, E. Bioli, M. Brighenti, R. Campovecchi, S. Carafoli, R. Caselli, L. Donatelli, L. Gervasi, V. Ghezzi, P. Guaitoli, R. Laudante, C. Malorgio, S. Manzoli, R. Massa, E. Melati, A. Morritti, A. Pallari, R. Petocchi, C. Richeldi, R. Rinaldi, F. Romeo, A. Roufki, N. Scaltriti, N. Sirotti, A. Vignudini, S. Zironi. The authors thank: G. Affuso and G. Ruggiero, researchers at the Department of Psychology of the Second University of Naples (SUN) for their statistical advices in the development of the revised version of this paper; and the 114 users for their active participation in the study.
Appendix A. Supplementary material Supplementary data associated with this article can be found in the online version at http://dx.doi.org/10.1016/j.psychres.2015.12.009.
References A dnøy Eriksen, K., Arman, M., Davidson, L., Sundfør, B., Karlsson, B., 2014. Challenges in relating to mental health professionals: perspectives of persons with severe mental illness. Int. J. Ment. Health Nurs. 23, 110–117. Anthony, W., Rogers, E.S., Farkas, M., 2003. Research on evidence based practices: future directions in an era of recovery. Community Ment. Health J. 39, 101–114. Anthony, W.A., Cohen, M., Farkas, M., 1990. Psychiatric Rehabilitation. Centre for Psychiatric Rehabilitation. Boston University, Boston. Berry, K., Barrowclough, C., Haddock, G., 2011. The role of expressed emotion in relationships between psychiatric staff and people with a diagnosis of psychosis: a review of the literature. Schizophr. Bull. 37, 958–972. Bradshaw, W., 2000. Integrating cognitive-behavioral psychotherapy for person with schizophrenia into a psychiatric rehabilitation program: results of a three year trial. Community Ment. Health J. 36, 491–500. Brissos, S., Palhavã, F., Marques, J.G., Mexia, S., Carmo, A.L., Carvalho, M., Dias, C., Franco, J.D., Mendes, R., Zuzarte, P., Carita, A.I., Molodynski, A., Figueira, M.L., 2012. The Portuguese version of the Personal and Social Performance Scale (PSP): reliability, validity, and relationship with cognitive measures in hospitalized and community schizophrenia patients. Soc. Psychiatry Psychiatr. Epidemiol. 47, 1077–1086. Candini, V., Buizza, C., Ferrari, C., Caldera, M.T., Ermentini, R., Ghilardi, A., Nobili, G., Pioli, R., Sabaudo, M., Sacchetti, E., Saviotti, F.M., Seggioli, G., Zanini, A., de Girolamo, G., 2013. Is structured group psychoeducation for bipolar patients effective in ordinary mental health services? A controlled trial in Italy. J. Affect. Disord. 151, 149155. Catty, J., White, S., Koletsi, M., Becker, T., Fioritti, A., Kalkan, R., 2011. Therapeutic relationships in vocational rehabilitation: predicting good relationships for people with psychosis. Psychiatry Res. 187, 68–73. Chien, W.T., Leung, S.F., Yeung, F.K., Wong, W.K., 2013. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr. Dis. Treat. 9, 1463–1481. De Girolamo, G., Picardi, A., Micciolo, R., Falloon, I., Fioritti, A., Morosini, P.L., Group, P.R.O.G.R.E.S., 2002. Residential care in Italy. National survey of non-hospital facilities. Br. J. Psychiatry 181, 220–225. Falloon, I.R.H., Boyd, J., McGill, C., 1984. Family of Care of Schizophrenia: a problem solving approach to the treatment of mental illness. Guildford Press, London. Falloon, I.R.H., 2003. Family interventions for mental disorders: efficacy and effectiveness. World Psychiatry 2, 20–28. Garcia-Portilla, M.P., Saiz, P.A., Bousoño, M., Bascaran, M.T., Guzmán-Quilo, C., Bobes, J., 2011. Validation of the Spanish Personal and Social Performance scale (PSP) in outpatients with stable and unstable schizophrenia. Rev. De. Psiquiatr. Y. Salud Ment. 4, 918.
27
Ghadiri Vasfi, M., Moradi-Lakeh, M., Esmaeili, N., Soleimani, N., Hajebi, A., 2015. Efficacy of aftercare services for people with severe mental disorders in Iran: a randomized controlled trial. Psychiatr. Serv. 66, 373380. Gigantesco, A., Vittorielli, M., Pioli, R., Falloon, I.R., Rossi, G., Morosini, P.L., 2006. The VADO approach in psychiatric rehabilitation: a randomized controlled trial. Psychiatr. Serv. 57, 1778–1783. Gühne, U., Weinmann, S., Arnold, K., Becker, T., Riedel–Heller, S.G., 2015. S3 guideline on psychosocial therapies in severe mental illness: evidence and recommendations. Eur. Arch. Psychiatry Clin. Neurosci. 265, 173–188. Holloway, F., Carson, J., Davis, S., 2002. Rehabilitation in the United Kingdom: research, policy, and practice. Can. J. Psychiatry 47, 628634. Johnson, D.W., Johnson, R.T., 1974. Instructional goal structure: cooperative, competitive, or individualistic. Rev. Educ. Res. 44, 213–240. Juckel, G., Morosini, P.L., 2008. The new approach: psychosocial functioning as a necessary outcome criterion for therapeutic success in schizophrenia. Curr. Opin. Psychiatry 21, 630–639. Juckel, G., Schaub, D., Fuchs, N., Naumann, U., Uhl, I., Witthaus, H., Hargarter, L., Bierhoff, H.W., Brüne, M., 2008. Validation of the personal and social performance (PSP) scale in a German sample of acutely ill patients with schizophrenia. Schizophr. Res. 104, 287293. Killaspy, H., 2014. Contemporary mental health rehabilitation. East Asian Arch. Psychiatry 24, 8994. Kolb, A., 1984. Experiential Learning: Experience as the Source of Learning and Development. Prentice Hall, Englewood Cliffs (NJ). Lecomte, T., Corbière, M., Simard, S., Leclerc, C., 2014. Merging evidence-based psychosocial interventions in schizophrenia. Behav. Sci. 4, 437–447. Ljungberg, A., Denhov, A., Topor, A., 2015. The art of helpful relationships with professionals: a meta-ethnography of the perspective of persons with severe mental illness. Psychiatr. Q., Jan 29 [Epub ahead of print] Lucksted, A., McFarlane, W., Downing, D., Dixon, L., 2012. Recent developments in family psychoeducation as an evidence based practice. J. Marital. Fam. Ther. 38, 101121. Magliano, L., Fiorillo, A., Malangone, C., De Rosa, C., Maj, M., Family Intervention Working Group, 2006a. Implementing psychoeducational interventions in Italy for patients with schizophrenia and their families. Psychiatr. Serv. 57, 266–269. Magliano, L., Fiorillo, A., Malangone, C., De Rosa, C., Maj, M., 2006b. Patient functioning and family burden in a controlled, real-world trial of family psychoeducation for schizophrenia. Psychiatr. Serv. 57, 1784–1791. Magliano, L., Marasco, C., Fiorillo, A., Malangone, C., Guarneri, M., Maj, M., 2002. The impact of professional and social network support on the burden of families of patients with schizophrenia in Italy. Acta Psychiatr. Scand. 106, 291–298. Magliano, L., Fiorillo, A., 2007. Psychoeducational family interventions for schizophrenia in the last decade: from explanatory to pragmatic trials. Epidemiol. Psichiatr. Soc. 16, 2234. Marshall, M., Crowther, R., Almaraz–Serrano, A., Creed, F., Sledge, W., Kluiter, H., Roberts, C., Hill, E., Wiersma, D., Bond, G.R., Huxley, P., Tyrer, P., 2001. Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care. Health Technol. Assess. 5, 1–75. Moher, D., Hopewell, S., Schulz, K.F., Montori, V., Gotzsche, P.C., Deveraoux, P.J., Elbourne, D., Egger, M., Altman, D.G., 2010. CONSORT 2010 Explanation and elaboration: updated guidelines for reporting parallel group randomized trials. Br. Med. J. 340, c896. http://dx.doi.org/10.1136/bmj.c869. Morosini, P.L., Magliano, L., Brambilla, L., Ugolini, S., Pioli, R., 2000. Development, reliability and acceptability of a new version of the DSM IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr. Scand. 101, 323–329. Morosini, P.L., Magliano, L., Brambilla, L., 1998. VADO Valutazione di Abilità e Definizione di Obiettivi. Edizioni Erickson, Trento. Nasrallah, H., Morosini, P.L., Gagnon, D.D., 2008. Reliability, validity and ability to detect change of the personal and social performance scale in patients with stable schizophrenia. Psychiatry Res. 161, 213–224. Patrick, D.L., Burns, T., Morosini, P.L., Rothman, M., Gagnon, D.D., Wild, D., Adriaenssen, I., 2009. Reliability, validity and ability to detect change of the clinician rated personal and social performance scale in patients with acute symptoms of schizophrenia. Curr. Med. Res. Opin. 25, 325338. Pioli, R., Vittorielli, M., Gigantesco, A., Rossi, G., Basso, L., Caprioli, C., Buizza, C., Corradi, A., Mirabella, F., Morosini, P.L., Falloon, I.R., 2006. Outcome assessment of the VADO approach in psychiatric rehabilitation: a partially randomised multicentric trial. Clin. Pract. Epidemiol. Ment. Health 3, 2–5. Quee, P.J., Stiekema, A.P.M., Wigman, J.T.W., Schneider, H., van der Meer, L., Maples, N.J., van den Heuvel, E.R., Velligan, D.I., Bruggeman, R., 2014. Improving functional outcomes for schizophrenia patients in the Netherlands using cognitive adaptation training as a nursing intervention a pilot study. Schizophr. Res. 158, 1205. Santone, G., de Girolamo, G., Falloon, I., Fioritti, A., Micciolo, R., Picardi, A., Zanalda, E., PROGRES Group, 2005. The process of care in residential facilities—a national survey in Italy. Soc. Psychiatry Psychiatr. Epidemiol. 40, 540–550. Schaub, D., Juckel, G., 2011. PSP scale: German version of the personal and social performance scale: valid instrument for the assessment of psychosocial functioning in the treatment of schizophrenia. Nervenarzt 82, 11781184. Srisurapanont, M., Arunpongpaisal, S., Chuntaruchikapong, S., Silpakit, C., Khuangsirikul, V., Karnjanathanalers, N., Samanwongthai, U., 2008. Cross cultural validation and inter rater reliability of the personal and social performance scale, Thai version. J. Med. Assoc. Thai 91, 16031608.
28
L. Magliano et al. / Psychiatry Research 235 (2016) 19–28
Stiekema, A.P., Quee, P.J., Dethmers, M., van den Heuvel, E.R., Redmeijer, J.E., Rietberg, K., Stant, A.D., Swart, M., van Weeghel, J., Aleman, A., Velligan, D.I., Schoevers, R.A., Bruggeman, R., van der Meer, L., 2015. Effectiveness and costeffectiveness of cognitive adaptation training as a nursing intervention in longterm residential patients with severe mental illness: study protocol for a randomized controlled trial. Trials 16, 49. http://dx.doi.org/10.1186/ s1306301505668. Velligan, D.I., Diamond, P.M., Maples, N.J., Mintz, J., Li, X., Glahn, D.C., Miller, A.L., 2008. Comparing the efficacy of interventions that use environmental supports to improve outcomes in patients with schizophrenia. Schizophr. Res. 102, 312319. Vittorielli, M., Pioli, R., Brambilla, L., Archiati, L., Rossi, G., Sleijpen, C., Magliano, L., Veltro, F., Morosini, P.L., 2003. Efficacy of the “VADO” approach in psychiatric rehabilitation: a controlled study. Epidemiol. Psichiatr. Soc. 12, 43–52.
World Health Organisation (WHO), Regional Office for Europe, 2010. User empowerment in mental health: a statement by the WHO Regional Office for Europe 〈www.euro.who.int/__data/assets/pdf_file/0020/113834/E93430.pdf〉. World Health Organisation (WHO), World Association for Psychosocial Rehabilitation (WAPR), 1996. Psychosocial Rehabilitation Consensus Statement 〈http:// www.wapr.info/World_Association_for_Psychosocial_Rehabilitation_WAPR/ Documents_files/WHO_WAPR_ConsensusStatement_96.pdf〉. Wu, B.J., Lin, C.H., Tseng, H.F., Liu, W.M., Chen, W.C., Huang, L.S., Sun, H.J., Chiang, S. K., Lee, S.M., 2013. Validation of the Taiwanese Mandarin version of the personal and social performance scale in a sample of 655 stable schizophrenic patients. Schizophr. Res. 146, 3439.