A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics

Psychiatry Research ∎ (∎∎∎∎) ∎∎∎–∎∎∎

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A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics Wai-Tong Chien n, Daniel Bressington School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong S.A.R, China

art ic l e i nf o

a b s t r a c t

Article history: Received 17 November 2014 Received in revised form 19 May 2015 Accepted 7 July 2015

This study aimed to test the effectiveness of a nurse-led structured psychosocial intervention program in Chinese patients with first-onset mental illness. A single-blind, parallel group, randomized controlled trial design was used. The study involved 180 participants with mild to moderate–severe symptoms of psychotic or mood disorders who were newly referred to two psychiatric outpatient clinics in Hong Kong. Patients were randomly assigned to either an eight-session nurse-led psychosocial intervention program (plus usual care) or usual psychiatric outpatient care (both n ¼90). The primary outcome was psychiatric symptoms. Outcomes were measured at recruitment, one week and 12 months post-intervention. Patients in the psychosocial intervention group reported statistically significant improvements in symptoms compared to treatment as usual. There were also significant improvements in illness insight and perceived quality of life and reduction in length of re-hospitalizations over the 12-month follow-up. The findings provide evidence that the nurse-led psychosocial intervention program resulted in improved health outcomes in Chinese patients with first-onset mental illness. & 2015 Elsevier Ireland Ltd. All rights reserved.

Keywords: Controlled trial First-episode mental illness Insight into illness Nurse-led program Psychosocial intervention Quality of life

1. Introduction People with first-and recent-onset serious mental health problems can experience significant delays in receiving treatment. Some of the reasons for these delays include family and/or patient reluctance to seek treatment and limited or non-accessible mental health services. This is concerning because a longer duration of untreated symptoms has been repeatedly shown to result in high relapse rates and poor long-term outcomes (Frank et al., 2009; Bird et al., 2010; Chen et al., 2011). Therefore, there is a clear need for appropriate early clinical intervention in order to improve prognosis. With this intention, international efforts have been made to reform community mental health services in order to avoid these unnecessary delays in treatment (Larsen et al., 2001). Perhaps one of the best examples of such reforms is the widespread introduction of early intervention services (EIS) for psychosis and other serious mental disorders across much of the developed world (Marshall and Rathbone, 2011; Stafford et al., 2013). Some studies that evaluate EIS delivered by large community-based mental health teams have demonstrated significant reductions in psychiatric symptoms and relapse rates when n

Corresponding author. Fax: þ 852 2364 9663. E-mail address: [email protected] (W.-T. Chien).

compared to standard treatment (Bertelsen et al., 2008; Bird et al., 2010). A Cochrane review of early intervention for psychosis (Marshall and Rathbone, 2011a) also concluded that there was promising evidence of the effectiveness of specialized early intervention services, particularly where treatments were stagespecific and engaged families. Similarly, an earlier Cochrane review of interventions to help people recognize the early warning signs of bipolar disorder (Morriss et al., 2007) reported the benefits of intervening early to prevent hospitalizations and improve functioning. A more recent systematic review and meta-analysis of early interventions to prevent psychosis (Stafford et al., 2013) concurred with the earlier studies in reporting that although the evidence is not conclusive, it is possible that psychological interventions can improve mental health outcomes when applied promptly after the first emergence of symptoms. There is also some limited evidence that services provided by similar specialized multidisciplinary teams in Hong Kong (e.g., Early Assessment Service for Youth) result in improvements in suicide rates, levels of symptoms and gains in employment (Chen et al., 2011). Some health economic studies also show that EIS for psychosis have the potential to reduce costs associated with losses in productivity and other healthcare costs (Mihalopoulos et al., 2009; McCrone et al., 2010, 2011), but regrettably such specialized services are not always in existence or available and therefore many people with first-episode psychosis or other early onset

http://dx.doi.org/10.1016/j.psychres.2015.07.012 0165-1781/& 2015 Elsevier Ireland Ltd. All rights reserved.

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

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W.-T. Chien, D. Bressington / Psychiatry Research ∎ (∎∎∎∎) ∎∎∎–∎∎∎

mental illnesses are referred to usual psychiatric outpatient services. Despite early treatment being essential for people with recentonset mental illness, many developed countries similar to Hong Kong still have long waiting lists for newly referred cases in general psychiatric outpatient services. This can result in delays of four to 12 weeks for service users to receive their first psychiatric consultation and/or subsequent treatment (Aron et al., 2009; Hospital Authority, Hong Kong, 2013). In Hong Kong the period of waiting time is determined by the urgency or priority of care established by initial mental health assessments conducted in outpatient clinics (Chien and Leung, 2013) and therefore patients not deemed as being at significant risk often face considerable delays in accessing psychiatric treatment. To address these gaps in services and provide as early intervention as possible, nurse-led mental health services could be a useful alternative approach when specialist EIS provided by larger multi-disciplinary mental health care teams are not available. However, there is still relatively scant evidence about the efficacy of approaches in the care of people newly referred to psychiatric services with an acute episode of first-onset mental illness (Haddock and Lewis, 2005; Bertelsen et al., 2008; Chien et al., 2012). One of the few studies on a nurse-led self-harm assessment and treatment program in the United Kingdom indicated that the service was potentially cost-effective and resulted in a significant reduction of self-harm behaviors and physical injuries (Griffiths et al., 2001). A similar encouraging pilot study (Chien and Leung, 2013) tested the effects and feasibility of a nurse-led, needs-based psycho-education program for first-onset Chinese schizophrenia sufferers and their families in Hong Kong with a six-month follow-up. The 48 participants in the intervention group reported statistically significant reductions in psychopathology, improved attitudes toward their illness and reduced re-hospitalization rates, when compared to those patients receiving treatment as usual. This earlier study utilized a range of nurse-led psychosocial interventions, which were underpinned by psycho-educational and motivational interviewing approaches. The previous pilot study also used elements of manualized adherence therapy and medication management interventions, which in some settings have been shown to be promising in improving medication adherence, reducing psychopathology and encouraging engagement with services (Maneesakorn et al., 2007; Harris et al., 2009; Gray et al., 2010; Brown et al., 2013). In this study we have built on our earlier work (Chien et al., 2012; Chien and Leung, 2013) and robustly tested a structured psychosocial intervention program using a similar combination of clinical approaches in a larger sample size of people who need to access immediate support. We decided to include patients in this study that had been newly referred with acute psychotic or affective symptoms but who had yet to receive an established psychiatric diagnosis. This choice was based on the fact that delays in accessing a psychiatrist for people not deemed as being at considerable risk are common Hong Kong and Western psychiatric outpatient care services and an early intervention as such provided in this study would be beneficial for people with first-onset mental illness in the absence of a formal psychiatric diagnosis. This approach could also minimize the risk of prolonged duration of untreated illness and enhance the generalisability of the intervention beyond a discreet group of patients. This randomized controlled trial therefore aimed to investigate the effects of a nurse-led psychosocial intervention program (PIP) for newly-referred Chinese patients with mild to moderate–severe symptoms of first-onset mental illness.

2. Methods 2.1. Trial design This study used a single-blind, parallel group randomized controlled trial with repeated-measures, control group design. The primary objective was to investigate the effects of the PIP on patients’ symptoms over a 12-month period compared to usual psychiatric outpatient care. This controlled trial also tested secondary outcomes relating to the effects on patients’ insight into illness and treatment, perceived self-efficacy, quality of life, and re-hospitalization rates over the 12-month follow-up. Assessment of patients’ outcomes was performed by a researcher (first author) blind to group allocation. The procedure of this controlled trial is summarized and presented in Figure 1. The controlled trial was registered at ClinicalTrials.gov Protocol Registration and Results System (ID: NCT02275390). There were no deviations from, or amendments to the original study protocol after the trial commenced. 2.2. Study setting This study was conducted in two regional general psychiatric outpatient clinics (OPDs) serving a population of approximately 800,000 (12% of the total population) in Hong Kong. Recruitment was commenced in December 2011 and ended in August 2012.The intervention was delivered between January and December 2012; and the follow-ups of patient outcomes were completed by the end of December 2013. 2.3. Ethical approval The study was approved by the Human Subject Research Ethics Committee of The Hong Kong Polytechnic University and the outpatient clinics under study (KC/KE-10-0024/ER-7). 2.4. Inclusion criteria The inclusion criteria for patients attending the OPDs were those who were: aged 18–60 years, with capacity to provide informed consent, able to understand Cantonese/Mandarin, having a first-onset of mental illness (psychotic and mood disorders) within the past three months, newly referred to mental healthcare services, and presenting at least mild to moderate–severe levels of psychiatric symptoms (i.e., Brief Psychiatric Rating Scale score of 425 out of 126 and/or Chinese version of the Beck Depression Inventory-II scores of 410 out of 63), but with no history of and low risk of suicide and self-harm (Overall and Gorham, 1962; Wu and Chang, 2008). Patients who did not meet the aforementioned inclusion criteria or who were receiving other psychosocial interventions organized by the clinics or other healthcare organizations, or who were classified as the highest priority of psychiatric consultation and treatment (i.e., starting their treatment and care plan with their attending psychiatrist and clinic nurse within one week) were excluded from the study. The urgency or priority of care was established by the OPD staff from the information included in the referral letters and via the initial mental health assessments conducted in the clinics. 2.5. Recruitment process A total of 480 Chinese patients were referred to and attended the two regional psychiatric outpatient clinics (OPDs) in Hong Kong between December 2011 and August 2012. The potential participants were assessed for suitability for study inclusion as per

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

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Patients with first-onset mental illness over five months of subject recruitment (N=480) Excluded – not able to meet study criteria (n=200) Assessed for eligibility (n=322) BDI-II score >10; BPRS >25

Refused to participate (n=42) mainly due to time inconvenience and lack of interest

Agreed for participation (n=280) Randomly selected (n=180) Sought written consent from patients who were found mentally competent and stable Conducted Pre-test (T1) on BPRS, ITAQ, PSES, WHOQoL-BREF, and socio-demographic data Group allocation by block randomization in terms of two clinics Assessed PIP participants on their priority of topics of interest in psycho-education

Randomly allocated to a 6-session PIP conducted over three months in the two clinics (n=90)

Randomly allocated to a control group, which only received routine psychiatric outpatient care over three months (n=90)

Examined frequency and duration of psychiatric admissions and OPD default followup from during 3-month intervention Entered follow-up (n=90) Completed intervention (n=87) Absented for>3 sessions (n=4) Withdrawn (n=0)

Entered follow-up (n=90) Completed intervention (n=90) Dropped out (n=0) Withdrawn (n=0)

Conducted post-tests at immediately (T2) and 12 months (T3) after completion of the interventions Recorded frequency and duration of psychiatric hospitalizations and default OPD follow-up Included in data analyses (n=90) Completed follow-up (n=87) Declined follow-up at T3 (n=3) Withdrawn (n=0)

Included in data analyses (n=90) Completed follow-up (n=86) Declined follow-up at T3 (n=4) Withdrawn (n=0)

Fig. 1. Flow diagram of study procedure of the randomized controlled trial.

the study protocol by a researcher. Of these potential participants 322 (67.1%) met the study inclusion criteria. These patients were given written information about the study at their first appointment with a nurse in the OPD and given opportunity to discuss the study and time to consider their involvement. After the appointment they were approached for informed consent by a researcher that was independent of the clinical team and not involved in data collection or analysis. Of these patients, two hundred and eighty (87.0%) agreed to participate.. The researcher allocated each consenting patient a unique identification number to maintain anonymity, before passing the list of numbers to a research assistant for selection of participants for baseline assessment and subsequent randomisation. 2.6. Randomization, concealment and blinding From the list of 280 identification numbers a total of 180 (64.3%) consenting patients were then randomly selected by an independent research assistant (not involved in outcome measurements, intervention and data analysis) to participate in this study using two sets of computer-generated random numbers (i.e., one for each clinic). The eligible patients who volunteered to participate were invited to attend the medical consultation and follow-up services, as well as the study interventions in the corresponding clinics.

The baseline measurements were conducted at their next OPD appointment, following this the participants were assigned by a statistician based in our in-house randomization service (who was blind to the subjects’ identity and not involved in any other part of the study) using computer-generated random numbers to either usual psychiatric outpatient care (n ¼90) or the PIP intervention (plus usual care; n ¼90). The randomization schedule was conducted using computer-generated random permuted blocks of six subjects. Due to the nature of the psychosocial intervention it was not possible to blind participants to their treatment allocation. However, to avoid subject biases or potential contamination of treatment effects, the participants were asked not to disclose their study participation to the clinic staff. The participant lists were also locked away and concealed from the clinic staff and researchers over the study period. 2.7. Data collection procedure The first author (who was blind to the group assignment) administered the outcome measures pre-test before randomization and two post-tests (at one week and 12 months after the completion of the interventions). After the initial psychiatric consultations in the OPDs, all participants were asked to complete a demographic data sheet, consisting of selected characteristics such as age, education level, onset of illness, and medication use in a

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

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Table 1 Overview of the purpose, objectives and indicative content of the Structured Psychosocial Intervention Program (PIP). Theme/Session

Purpose/Objectives

Main Content

Theme 1: Orientation, engaging and understanding of mental health/illness, its related behaviors and community support resources; (1 session)

(1) Overview of the intervention program and members’ expected extent of participation (2) Establishing a therapeutic relationship by showing professional knowledge, empathy, understanding, and concern about personal health needs (3) Understanding of mental health and illness and related behaviors (4) Understanding of treatment, medication and community services available according to individual needs

(1) Outlining the services available in the psychiatric outpatient clinic(s), the contents of the PIP intervention, and assessment strategies used; (2) Obtaining a full medical, family and psychiatric history. Mental health, suicide and violence risk assessment, and need for crisis intervention; (3) Education on etiology, clinical features and course of serious mental illnesses (psychotic and mood disorders); (4) Recognizing early warning signs of increased symptom severity and devising practical strategies to access support; (5) Exchanging information about community mental health and physical care services; and potential subsequent need for referral; (6) Overview of medications for mental health (including desired and adverse effects), and discussion about patient’s prescribed treatment; and (7) Agreeing the venue and time schedule of subsequent sessions.

Theme 2: Working collaboratively and empowering patients using motivational interviewing approaches (2 sessions)

(1) Collaborating and empowering patients to take personal choice, responsibility and ownership of a clear agenda for treatment and recovery (2) Facilitating patient to gain family and social support (3) Establishing effective medication management by exploring and enhancing motivation

(1) Ongoing assessment of patient’s mental state, and initial discussion about sleep patterns and sleep hygiene; (2) Discussion about patient’s attitude and insight into his/her illness and the perceived need for treatment; (3) Working collaboratively to set an agenda for treatment with empathy and support; emphasizing personal responsibility for health behaviors, illness management and recovery; (4) Enhancing self-efficacy and minimizing tension and resistance on illness management and inviting new perspectives to their own treatment/care; (5) Exchanging information and mutual support about treatment and rehabilitation; (6) Family relationship and support; advice on medication management with support from family members; and (7) Ongoing encouragement to attend the coming sessions.

Theme 3: Social and interpersonal skills training; (2 sessions)

(1) Learning and practicing effective interpersonal and communication skills (2) Applying these learned skills to family and social situations (3) Continuing motivational interviewing technique in self-management of illness

(1) Effective basic communication skills (2) Rehearsals of interpersonal skills through role playing and practicing the learned skills at home; (3) Discussion about specific psychosocial needs, family issues, and social activities and situations (including traditional Chinese cultural tenets); and (4) Review on the use of communication strategies and resolving tension/conflict in life situations.

Theme 4: Coping strategy enhancement for symptoms of mental illness and anxiety (2 sessions)

(1) Building effective coping skills (2) Instillation of hope and relaxing life attitudes and behaviors (3) Assessing mental status (particularly anxiety, depression and sleep problems) and providing advice about managing individual mental health problems (4) Providing knowledge and skills in stress management and coping (5) Providing channels for reflection and exploration of feelings

(1) Assessment of depression and anxiety, and insight into to the illness and treatment; (2) Exploration of feelings towards mental illness and its self-management, as well as family support; (3) On-going risk assessment and determining need for emergency care (e.g., urgent psychiatric consultation and crisis intervention); (4) Understanding of individual coping strategies used and strengthening the existing or alternative ones as needed; (5) Instillation of hope and sense of well-being; (6) Promotion of sleep hygiene and healthy lifestyle; (7) Discussion about treatment adherence and the potential appropriate use of medication to help cope; (8) Suggestions on ways of coping and social support, and community support services; (9) Stress management and relaxation exercise

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

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Table 1 (continued ) Theme/Session

Purpose/Objectives

Main Content training and practice; and (10) Encouraging follow-up contact via phone before the next session.

Theme 5: Reviewing sessions and establishing a realistic plan for future (1 session)

(1) (2) (3) (4)

Review on skills and knowledge learned Reinforcing benefits of treatment adherence Implementation of program evaluation Establishing a realistic plan for the near future

quiet interview room. Participants’ psychiatric medications used during the intervention and over the 12-month follow-up were also recorded. Their amounts (frequency) and lengths of psychiatric hospitalizations and frequency of OPD default follow-ups in the previous four and 12 months were also recorded at the first and second post-tests, respectively. 2.8. Interventions The nurse-led psychosocial intervention program (PIP) aimed to empower patients to manage their psychiatric symptoms by enhancing their coping skills and improving their understanding of mental illness. The structured programme was modified from interventions previously tested by the research team (Clarke et al., 2002; Yung et al., 2003; Chien et al., 2012; Chien and Leung, 2013; Chien and Thompson, 2014), and from adherence therapy for people with psychotic disorders (Gray et al., 2010). The PIP intervention was provided to participants within faceto-face individual meetings by one psychiatric advanced practice nurse (APN) in each clinic. The intervention comprised of eight 2-hour sessions held every two weeks (i.e. over four months). The APNs coordinated all levels of the intervention program and in partnership with the participants, prioritized the sequences of the topics (in the themes [b]–[d] below) to be delivered according to participants’ individual mental health and educational needs. The five themes that the APNs covered were: (a) orientation, engaging and understanding of mental health/illness, its related behaviors and community support resources; (b) working collaboratively and empowering patients using motivational interviewing approaches; (c) social and interpersonal skills training; (d) coping strategy enhancement for symptoms of mental illness and anxiety; and (e) reviewing sessions and establishing a realistic plan for future. The program also adopted some specific strategies to address traditional Chinese cultural tenets regarding communication and interpersonal relationships. Throughout the intervention participants were required to engage in rehearsals of coping and communication skills which focused on improving interactions and relationships with family members and friends by resolving challenges, conflicts and behavioral disturbances within their daily lives. More details of the program are described in Table 1, indicating its main objectives and content in each of the five themes. No modifications to the interventions were required following the

(1) Reviewing and reinforcing the knowledge and skills learned during the program; (2) Evaluation of personal, community and family resources and coping skills; (3) Exploration of how engagement with future treatment fits in with patients life-goals; (4) Advice about regular follow-up in the outpatient clinic and importance of long-term medication adherence; (5) Liaising with other mental health professionals for appropriate services and psychological support in coping with the illness; and (6) Planning for self-management, work, family and social activities, and other life issues in the coming year.

intervention training, or during the course of the study. 2.9. PIP intervention training The two APNs were trained by the researchers within a two day workshop. In order to improve fidelity to the treatment model the APNs were then supervised whilst they delivered the PIP intervention to five patients with first-onset mental illness before starting this study. 2.10. Clinician fidelity to intervention Two of the eight sessions delivered as part of the trial were randomly selected in one-third of the participants (n¼ 30) in the PIP group and audio-recorded for monitoring of intervention fidelity using a checklist based on the NIH Behavior Change Consortium recommendations (Bellg et al., 2004). The checklist was used to track adherence to topics and instructions by a trained research assistant, as suggested by the NIH Behavior Change Consortium recommendations (Bellg et al., 2004). In addition to checking that the APNs followed the recommended delivery of each intervention in line with the study protocol, the adequacy of APNs skills and overall management of the therapeutic sessions were also scored by one researcher, using a modified version of the Cognitive Therapy Scale (Haddock et al., 2001). A different researcher (the second author) who was blind to the origins of the recordings and ratings compiled/analysed the scores. The analysis revealed intervention fidelity and APN competence scores ranging from 90.3% to 92.8% and a mean of 91.7% and 92.5%, respectively for the PIP delivered by the two APNs. There were no significant differences in fidelity scores between the two APNs and clinics under study (both p values o0.10). 2.11. Usual care The usual care (and PIP) group received routine psychiatric outpatient care provided by the clinics. These services consisted of medical consultation and usual treatment by a psychiatrist (i.e., around every four weeks) and referrals for community mental health and social welfare services available by a psychiatric nurse or medical social worker in each clinic. Once patients had attended their first outpatient consultation, they were offered brief educational sessions (i.e., 3 or 4 one-hour sessions during the course of

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

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the study) about mental illness and its treatment delivered by psychiatric nurses. The APNs involved in the study were not involved in delivering any of this routine care. 2.12. Outcome measures The primary and secondary outcome measures were assessed at recruitment, at one week and at 12 months after completion of their interventions.. 2.12.1. Primary outcome Brief Psychiatric Rating Scale (BPRS) The Chinese language version of 18-item BPRS has been widely used to assess patients’ mental state in psychiatry settings (Xia et al., 2011). This scale has been used globally in mental health services research, with previous studies indicating good content validity and internal consistency (Cronbach’s alpha ¼ 0.88) (Overall and Gorham, 1962; Chien et al., 2006). Its items are rated on a 7-point Likert scale for each item (0 ¼ not assessed, 1 ¼not present to 7¼ extremely severe). A higher score suggests a greater level of psychopathology. 2.12.2. Secondary outcome measures Insight and Treatment Attitudes Questionnaire (ITAQ) The ITAQ (McEvoy et al., 1989) was used to measure patients’ awareness of illness and insight into their needs for treatment. The Chinese version used in this study has satisfactory internal consistency and good inter-rater reliability (Chien and Wong, 2007; Chien and Leung, 2013). Perceived Self-efficacy Scale (PSES) The PSES (Jerusalem and Schwarzer, 1992) is a measure of self perception about competence to manage challenging and stressful encounters in life situations. The Chinese language version (Zhang and Schwarzer,1995) has good internal consistency and content validity. Higher scores suggest better self-efficacy. World Health Organization Quality of Life Measure-Brief version (WHOQoL-BREF) The Chinese version of the WHOQoL-BREF (Leung et al., 1997) was modified from the WHOQoL-100 (World Health Organization, 1995), it has been shown to have satisfactory internal consistency and test-retest reliability among Chinese psychiatric patients (Leung et al., 1997; Fung and Chien, 2002). Hospitalization and default follow-up rates Frequencies and lengths of psychiatric hospitalizations and OPD default follow-up rates of the participants during the intervention and 12 months follow-up were calculated by asking the participants and checking the information against their clinical records. 2.13. Sample size Based on our earlier similar controlled trials of nurse-led psycho-education programs in Chinese populations (Chien and Wong, 2007; Chien et al., 2012; Chien and Leung, 2013) we calculated that a sample size of 180 patients was adequate to detect an average effect size of 0.46 (i.e., 0.42–0.52 in the three cited studies) on both severity of psychiatric symptoms (Brief Psychiatric Rating Scale score) and average length of psychiatric hospitalizations over six months between the PIP and usual care group at a 5% significance level with a power of 90%, and accounting for potential patient attrition of 15% (Stevens, 2002). 2.14. Data analysis Data were analyzed by a researcher who was blind to the treatment group allocation using the IBM SPSS for Windows,

version 20.0. Analysis was conducted on an intention-to-treat basis that maintained the advantages of random allocation (Tabachnick and Fidell, 2001). Attendance to the PIP sessions and attrition rate were recorded and calculated. Differences in demographic characteristics and types and levels (or dosage) of psychiatric medication between two study groups and those eligible non-participants were assessed by one-way analysis of variance (ANOVA) or Chi-square test as appropriate. Four outcome measures (BPRS, ITAQ, PSES, and WHOQoL-BREF) at baseline (T1) between two study groups and between the two clinics under study within each of the two groups were compared by using independent samples t-test (two-tailed). Missing data were filled up by bringing forward the last measurement scores (Stevens, 2002). Without any covariant effect of the baseline mean scores and violation of assumptions of normality identified, repeated-measures analysis of variance (ANOVA) tests were performed for each of the above-mentioned four outcome variables to determine the treatment effects over time (group  time interaction effects). Two-way ANOVA tests were adopted to assess compare the hospitalization and OPD default follow-up rates between groups across two post-tests. Helmert contrasts codes were adopted to test any significant differences between groups on those outcome measures that indicated a significant interactive (group  time) effects in the repeated-measures or two-way ANOVA tests (Tabachnick and Fidell, 2001). Due to multiple comparisons using univariate analyses, we applied Bonferroni’s corrections to reduce Type 2 errors; the level of statistical significance was therefore set at p ¼0.01 (McDonald, 2009).

3. Results Eighty-six of the PIP participants (95.6%) completed the program (i.e., an attendance of at least five sessions); three participants in the PIP (3.3%) and four in the usual care group (4.4%) could not be contacted at 12-month follow-up. Based on intentionto-treat principle, the data of all of the 180 participants (i.e., 90 in each group) were included in final data analysis. Attendance rate of the PIP was 88% (range¼3–8 sessions, median¼5.0 sessions). 3.1. Demographic and illness-related characteristics The socio-demographic and illness-related characteristics of the two groups of participants and consenting eligible non-participants (n ¼ 100) are summarized in Table 2. For the two study groups, more than half of the participants were male and aged 18– 29 years, with a mean age of around 25 years. About 80% of participants had less than three months of mental illness. In addition, 490% of them had mild and moderate levels of depression and a monthly family income of HKD 5000–25,000 (US$ 641–3205). More than 85% of the participants had low to medium dosage of psychiatric medication during the intervention period and were living with one to three family members. As indicated in Table 2, the participants in the two study groups and those non-participants did not indicate any significant differences in their socio-demographic and clinical characteristics between groups (p values Z0.10). There were also not any significant differences on the mean scores of outcome measures between study groups at baseline (refer to Table 3 for mean scores of outcome measures at baseline) and these outcomes between two clinics under study, using independent samples t-test (two-tailed, p values 40.01), indicating homogeneity of the participants in the two study groups and settings at baseline.

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

W.-T. Chien, D. Bressington / Psychiatry Research ∎ (∎∎∎∎) ∎∎∎–∎∎∎ Table 2 Characteristics of participants received PIP, usual psychiatric care only and those eligible non-participants at recruitment. Characteristics

Gender Male Female Age 18–29 30–39 40–49 Duration of illness (months) o2 2–3 4–6 7–9

month months months months

BDI-II (0–63) 9–15 16–23 24–30 Number of family members living with patient One 2–3 4–5 None Monthly household income (HK$) c 5000–10,000 10,001–15,000 15,001–25,000 25,001–35,000 Type of psychiatric medication during intervention Antipsychotics Conventional Atypical Anti-depressants Blended moded Nil medication Dosage of medicatione High Medium Low

PIP (n ¼90)a

Usual care (n ¼90)a

Non-partici pants (n ¼100) a

48 (53.3) 42 (46.7)

50 (55.6) 40 (44.4)

52 (52.0) 48 (48.0)

24.97 8.0, 18–45 51 (56.7) 25 (27.8) 14 (15.6)

25.2 78.7, 19–48 50 (55.6) 30 (33.3) 10 (11.1)

2.87 1.8, 3 weeks–6 months 28 (31.1) 41 (45.6) 20 (22.2) 1 ( 1.1) 18.1 77.5, 10–26 48 (53.3) 34 (37.8) 8 ( 8.9)

Test value

b

1.60

0.23

27.27 10.9, 18–50 53 (53.0) 36 (36.0) 11 (11.0)

1.50

0.24

2.7 72.5, 3 weeks–7 months 32 (35.6) 38 (42.2) 16 (17.8) 4 ( 4.4)

3.47 3.8, 2 weeks–9 months 30 (30.0) 45 (45.0) 18 (18.0) 7 ( 7.0)

2.53

0.08

19.37 7.3, 10–27 47 (52.2) 36 (40.0) 7 ( 7.8)

20.1 7 9.8, 9–30 50 (50.0) 40 (40.0) 10 (10.0)

1.28

0.29

2.30

0.10

46 (51.1) 33 (36.7) 8 ( 8.9) 3 ( 3.3)

44 (48.9) 32 (35.6) 10 (11.1) 4 ( 4.4)

49 (49.0) 36 (36.0) 7 ( 7.0) 8 ( 8.0)

13,100 7 2,983

14,0957 2,798

15,793 7 3,385

22 (24.4) 32 (35.6) 30 (33.3) 6 ( 6.7)

20 (22.2) 34 (37.8) 29 (32.2) 7 ( 7.8)

25 (25.0) 38 (38.0) 31 (31.0) 8 (8.0)

22 (24.4) 21 (23.3) 16 (17.8) 16 (17.8)

21 (23.3) 24 (26.7) 18 (20.04) 12 (13.3)

25 (25.0) 27 (27.0) 17 (17.0) 16 (16.0)

15 (16.7)

15 (16.7)

15 (15.0)

The results of the repeated-measures ANOVA test demonstrated that the participants in the PIP indicated significantly greater improvements over time (Group  Time interactions) in the primary outcome (their BPRS score ). Similarly, insight into the illness and its treatment (ITAQ score) and perceived quality of life (WHOQol-BREF score) also improved when compared with those in usual psychiatric care. In addition, the PIP participants also showed a significant greater reduction of the average duration of psychiatric hospitalisations over the 12-month follow-up. However, the types and average dosage of medication taken in terms of haloperidol-equivalent mean values (Virani et al., 2012) did not differ between the two groups over the 12-month follow-up (p 40.10). Results of Helmert’s contrasts tests indicated that the mean differences of the following outcomes between the two study groups were significant at 0.01 or 0.001, thus contributing to overall significant interactive (group  time) treatment effect on:



 1.98

0.13



0.12

showed significantly greater reduction of BPRS mean score at two post-tests over 12 months, that is, mean difference¼3.2, F (1,178) ¼ 8.9, p ¼0.01 and mean difference ¼6.2, F(1,177)¼12.3, p¼ 0.001, respectively, when compared to those in usual care. Insight into illness and its treatments (ITAQ score) in which the PIP participants improved significantly greater than the usual care group at two post-tests, that is, mean difference¼ 3.6, F (1,178) ¼11.2, p ¼ 0.001 and mean difference¼ 5.4, F(1,177)¼ 14.8, p ¼ 0.001, respectively. Quality of life (WHOQoL-BREF) score in which when compared to those in usual care, the PIP participants indicated significantly greater improvement at two post-tests, mean difference ¼11.6, F(1,178) ¼9.2, p¼ 0.008 and mean difference ¼16.4, F(1,177)¼14.2, p ¼0.001, respectively. Average length of hospitalizations (day/month) in which the PIP participants indicated significantly greater reduction at the second post-test (12 months after intervention), mean difference ¼3.2, F(1,178) ¼11.4 and p ¼ 0.01, when compared to those in usual care; whereas for those in the usual care group, it increased only slightly from the first to the second post-test.

4. Discussion

1.22 12 (13.3) 60 (66.7) 18 (20.0)

3.2. Treatment effects over 12-month follow-up

 Symptom severity (BPRS) score in which the PIP participants

2.01

13 (14.4) 60 (66.7) 17 (18.9)

p

7

0.29

11 (11.0) 64 (64.0) 25 (25.0)

Note: PIP, Nurse-led Psychosocial Intervention Program in two outpatient clinics under study; BDI-II, Beck’s Depression Inventory-II. a Data in each column denotes frequency (f %) or mean7 standard deviation and range. b An analysis of variance (F-test, df ¼ 2, 276) or the Kruskal–Wallis test by ranks (H statistic, df ¼ 2) was used to compare the baseline socio-demographic and clinical characteristics of participants between groups. c US$1 ¼HK$7.8 d Participants were taking more than one type of psychotropic medication, e.g., both conventional and atypical antipsychotics or both atypical antipsychotic and antidepressant. e Dosage levels of psychotropic medications were compared with the average dosage of medication taken in haloperidol-equivalent mean values (Virani et al., 2012).

The findings of this controlled trial provide evidence that the PIP structured psychosocial intervention provided by the APNs significantly improved the psychiatric symptoms of patients with recent-onset psychotic or mood disorders over a 12-month period. In terms of the secondary outcomes; the duration of re-admissions, perceived quality of life, and insight into illness/treatment were also found to have improved. No significant differences were found in number of hospitalizations, perceived self-efficacy, or number of defaulted follow-ups in the outpatient clinics. The PIP program aimed to address multiple important health needs of people at early stages of mental illness who were newly referred to psychiatric services by utilizing clinical interventions designed to equip patients with the knowledge and skills to better manage their symptoms of depression, anxiety and/or psychosis. The psychoeducation components of the PIP intervention which involved the learning of effective coping and problem-solving skills may have had a direct beneficial effect on psychiatric symptoms. These approaches are often considered important therapeutic components in previous studies (Martin et al., 2004; Aron et al., 2009; Chien and Norman, 2009) and have also been

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

W.-T. Chien, D. Bressington / Psychiatry Research ∎ (∎∎∎∎) ∎∎∎–∎∎∎

8

Table 3 Outcome measure scores and results of repeated-measures ANOVA (group  time) for participants in two groups from T1 to T3. Instrument

PIP (n¼ 90) T1

BPRS ITAQ PSES WHOQoL-BREF Default OPD follow-up Hospitalization rate Numbera Duration (days/month)b

Usual care (n¼ 90) T2

T3

T1

T2

F†, p

(Effect size)

(0.56) (0.60) (0.21) (0.42) (0.15) (0.17) (0.45)

T3

Mean

SD

Mean

SD

Mean

SD

Mean

SD

Mean

SD

Mean

SD

14.7 8.1 19.4 50.4

7.9 2.8 7.1 10.8

11.5 12.6 21.2 59.8 0.9

8.9 6.7 7.8 10.2 0.8

9.6 14.8 22.1 68.4 1.0

5.7 4.8 9.0 11.8 0.7

13.5 9.1 19.8 51.8

4.9 1.9 4.8 9.1

14.7 9.0 20.2 48.2 0.9

9.0 3.1 9.5 10.1 1.0

15.8 9.4 20.1 52.0 1.3

10.1 2.3 10.8 1.0

7.52, 0.001, 8.15, 0.001, 3.89, 0.09 10.94.98, 0.01 2.01, 0.14

1.1 4.9

1.2 2.8

1.0 3.8

0.9 3.0

– –

1.4 6.0

1.1 4.3

1.7 7.0

1.5 5.6

3.07c, 0.12 5.79c, 0.01

– –

–

– –

Note. PIP, Nurse-led Psychosocial Intervention Program in the outpatient clinic under study. T1, Pre-test at recruitment; T2, First post-test at immediately after interventions; T3, Second post-test at 12 months after interventions. BPRS, Brief Psychiatric Rating Scale; possible scores range from 0 to 7, with higher scores indicating greater severity of symptoms. ITAQ, Insight and Treatment Attitudes Questionnaire; possible scores range from 0 to 22, with higher scores indicating better insight. PSES, Perceived Self-Efficacy Scale; possible scores range from 10 to 40, with higher scores indicating high competence to manage difficult life situations. WHOQoL-BREF, World Health Organization Quality of Life Measure—Brief Version; possible scores range 28–140, with higher scores indicating better perceived quality of life or general health status. OPD, Outpatient Department a

Average number of readmissions per month to a psychiatric inpatient unit over 3 or 12 months at two post-tests. Average length of readmissions to a psychiatric inpatient unit in terms of average number of days of hospital stay over the past 3 months at T2 or the past 12 months at T3. c F value of two-way ANOVA test between groups across T2–T3. † df ¼ 1, 178 b

shown to improve patients’ engagement with and effective use of mental health services (Bridge and Barbe, 2004). The motivational interviewing techniques used by the APNs were designed to enhance patients’ ability in managing their illness (Laakso, 2011) via improved insight and self-empowerment (Baldessarini et al., 2008; Laakso, 2011). Motivational interviewing was also used to enhance treatment adherence and this might also have improved patients’ perception of the need for treatment by helping them understand that taking medication as prescribed may be necessary in order for them to achieve their life goals. Previous studies that use similar therapeutic approaches targeted at medication adherence have also reported an increased recognition of the need for treatment and associated improvements in patients’ symptoms (Gray et al., 2010; Schulz et al. 2013; von Bormann et al. 2014). As recommended by Eloff and Ebersohn (2001), the latter parts of the program also solicited support from family and healthcare services and could have satisfied some of the cultural doctrines of Chinese patients. The focus on improving familial relationships in a densely populated environment such as Hong Kong where many family members often live together in cramped conditions may have reduced stress in the home environment and therefore might contribute to an improvement in patients’ symptoms and perceived quality of life over the follow-up. These findings are encouraging because although some previous studies have demonstrated reductions in the need for institutionalized care (Lenior et al., 2001), such a significant increase of quality of life has seldom been reported in previous research for people with chronic mental illness (Xia et al., 2011; Harvey and O’Hanlon, 2013). It is interesting to note that the study sample had a later onset of mental illness (average age of 25 or 450% ranged 24–30 years) than those reported in Western developed countries (Kessler et al., 2005). This may suggest that due to fears about social stigmatization towards mental illness many Chinese families might have resisted taking their relatives to seek treatment for some considerable time (Chien et al., 2006, 2012; Chien and Leung, 2013). Cultural influences on the structure, format and process of psychosocial interventions should be carefully considered in future research. In addition to the positive patient outcomes, the majority of

participants (around 96%) completed the PIP (i.e., an attendance of at least five sessions) and remained in this study over the 12month follow-up. The high attendance rate (88%) of the PIP and the very low attrition rates of the study might be due to patients’ positive views about the acceptability of the intervention. It is also possible that high follow-up rate could indicate that the patients may have felt coerced into participating; however, we went to great lengths to avoid this and reiterated throughout that withdrawal from the study would not result in penalization of any kind. Similarly low attrition rates in studies involving Chinese patients have also been reported in other studies (Chien and Chan, 2004; Bressington, Mui and Gray, 2012) and it has been hypothesized that increased retention rates may be related to culturally defined perceptions of a strong relationship between patient and health care provider, and greater patient compliance with study protocols (Yang, 2008). In addition, it is important note that fidelity of the trained APNs’ adherence to the PIP treatment protocol was assured by using a modified version of a validated checklist and NIH guidelines (Haddock et al., 2001; Bellg et al., 2004), resulting in a high fidelity score (4 90%). Some psychoeducation and supportive interventions for community-residing people with serious mental illness in the United States using comparable fidelity checklists have also demonstrated a similar overall fidelity score (Borrelli et al., 2005; Cook et al., 2012). 4.1. Limitations of the study The results of this trial should be considered in light of the study limitations. The patients involved in the study were relatively young (nearly 90% aged o40 years) and had a satisfactory monthly income and family support (or were living with family members), and thus might have been well-motivated to participate in the intervention (i.e., resulting in the very high intervention attendance and low attrition rate). As patients involved in the study presented with mild to moderate–severe psychiatric symptoms, the patterns of socio-demographic and illness characteristics might also not be representative of other Chinese psychiatric patient populations. Due to the inclusion and exclusion criteria the

Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i

W.-T. Chien, D. Bressington / Psychiatry Research ∎ (∎∎∎∎) ∎∎∎–∎∎∎

generalisability of our findings is further limited to patients that have yet to receive a formal psychiatric diagnosis, are not deemed as being a high risk and who are not receiving other psychosocial interventions. Future research with patients with more severe symptoms and over a longer-term follow-up (e.g., at least 18 months) may allow investigation of the relationships between the perceived benefits and the intervention techniques applied in the PIP, as well as potential therapeutic mechanisms of the intervention via individual or group interviews and/or observation studies (Chien et al., 2006). Although we found no difference between the two study groups relating to the types and dosage of medication taken, we did not record data about side-effects, adherence with treatment and changes in medication, which could have influenced patients’ mental state and their insight into illness/treatment. Further research on such medication-related variables within psychosocial intervention trials is recommended. Another potential confounding factor was that we did not enquire about patients’ use of nonprescribed substances or alcohol and future research should therefore consider gathering such data in order to explore any possible relationship between substance use and clinical outcomes. Lastly, the participants and APNs in this study were not blind to the treatment condition and usual outpatient care was chosen as the control condition. Therefore their preconceived benefits of the PIP and the Hawthorne effect could have influenced their responses or efforts in and enthusiasm for the intervention, and thus the study outcomes. 4.2. Conclusions This nurse-led, structured psychosocial intervention program (PIP) for people with recent first-onset mental illness was more effective than usual psychiatric outpatient care in reducing the symptoms of patients newly referred to services. The findings of this study therefore suggest that the intervention may constitute an effective treatment strategy for patients reporting mild to moderate–severe symptoms of mental illness where early intervention services provided by specialized multidisciplinary teams are not available. Further investigation of the intervention’s longterm effects in comparison with other approaches to psychosocial intervention and with patients from different stages and duration of illness, as well as diverse socio-cultural backgrounds or comorbidities of other mental illnesses, is also recommended.

Contributors WTC has contributed to literature review, study design, data collection and analysis and manuscript preparation; and DB has contributed to literature review, study design and manuscript preparation.

Disclosure for conflict of interest The authors declare that they have no potential conflicts of interest for this study.

Acknowledgements This research was supported by The University Competitive Research Grant 2009–10, The Hong Kong Polytechnic University. The authors thank the two outpatient clinics and their staff for their assistance in recruitment of participants and data collection.

9

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Please cite this article as: Chien, W.-T., Bressington, D., A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Research (2015), http://dx.doi. org/10.1016/j.psychres.2015.07.012i