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Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country
SCHRES-06274; No of Pages 6 Schizophrenia Research xxx (2015) xxx–xxx
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Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country Farooq Naeem a,⁎, Sofiya Saeed b, Muhammad Irfan c, Tayyeba Kiran d, Nasir Mehmood d, Mirrat Gul e, Tariq Munshi a, Sohail Ahmad f, Ajmal Kazmi g, Nusrat Husain h, Saeed Farooq i,j, Muhammad Ayub a, David Kingdon k,l a
Department of Psychiatry, Queens University, Kingston, Canada Pakistan Association of Cognitive Therapists, Karachi, Pakistan c Department of Psychiatry and Behavioural Sciences, Peshawar Medical College, Peshawar, Pakistan d Pakistan Institute of Living and Learning, Karachi, Pakistan e Sir Ganga Ram Hospital, Lahore, Pakistan f Department of Psychiatry, Abbasi Shaheed Hospital, Karachi, Pakistan g Department of Psychiatry, Karwan e Hayat Hospital, Karachi, Pakistan h Institute of Brain, Behaviour and Mental Health, University of Manchester, UK i Department of Psychiatry, PGMI Lady Reading Hospital Peshawar, Pakistan j Staffordshire University, UK k Mental Health Care Delivery, University of Southampton, UK l Southern Health NHS Trust, UK b
a r t i c l e
i n f o
Article history: Received 24 November 2014 Received in revised form 17 February 2015 Accepted 21 February 2015 Available online xxxx Keywords: Schizophrenia Positive and negative symptoms Psychopathology Insight
a b s t r a c t Evidence for the effectiveness of Culturally adapted CBT for psychosis in Low And Middle Income Countries (LAMIC) is limited. Therefore, brief Culturally adapted CBT for psychosis (CaCBTp) targeted at symptoms of schizophrenia for outpatients plus treatment as usual (TAU) is compared with TAU. A total of 116 participants with schizophrenia were recruited from 2 hospitals in Karachi, Pakistan, and randomized into two groups with 1:1 allocation (CaCBTp plus TAU = 59, TAU = 57). A brief version of CaCBTp (6 individual sessions with the involvement of main carer, plus one session for the family) was provided over 4 months. Psychopathology was measured using Positive and Negative Syndrome Scale of Schizophrenia (PANSS), Psychotic Symptom Rating Scales (PSYRATS), and the Schedule for Assessment of Insight (SAI) at baseline and end of therapy. Participants in treatment group, showed statistically significant improvement in all measures of psychopathology at the end of the study compared with control group. Participants in treatment group showed statistically significant improvement in Positive Symptoms (PANSS, Positive Symptoms Subscale; p = 0.000), Negative Symptoms (PANSS, Negative Symptoms subscales; p = 0.000), Delusions (PSYRATS, Delusions Subscale; p = 0.000), Hallucinations (PSYRATS, Hallucination Subscale; p = 0.000) and Insight (SAI; p = 0.007). The results suggest that brief, Culturally adapted CBT for psychosis can be an effective treatment when provided in combination with TAU, for patients with schizophrenia in a LAMIC setting. This is the first trial of CBT for psychosis from outside the western world. These findings need replicating in other low and middle income countries. © 2015 Elsevier B.V. All rights reserved.
1. Introduction Cognitive Behavioural Therapy for psychosis (CBTp) is an evidencebased adjunct to medication in treating schizophrenia, and is recommended by National Treatment Guidelines in High Income Countries (APA, 2006; NICE, 2009). Cognitive Behaviour Therapy like other modern therapies was developed in the West, and is therefore underpinned by the Western cultural values. The explanatory models of illness are ⁎ Corresponding author. E-mail address: [email protected] (F. Naeem).
often rooted in local cultural and religious beliefs and values, which need to be addressed in any psychosocial intervention as these play a very important role in help seeking and health-related behaviours (Joel et al., 2003; Kleinman, 1980; Lloyd et al., 1998). There is evidence to suggest that people in Pakistan can attribute spiritual causes to psychotic symptoms (Zafar et al., 2008), and are more likely to consider seeking help from faith healers, compared with their western counterparts (Furnham et al., 2008). Therefore, it has been recommended that CBT needs cultural adaptation before its application in Non Western culture (Hays, 2009; Rathod and Kingdon, 2009). Our work in Pakistan using mixed methods research to culturally adapt CBT for psychosis
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Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
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has shown that numerous adjustments need to be made for CBT to be acceptable, accessible and effective (Naeem et al., 2009a,b, 2010, 2011, 2012). There is currently no published RCT of CBTp from Low and Middle Income Countries (LAMIC). There is at least one study from a High Income Country in which CBTp was culturally adapted for ethnic minority participants (Rathod et al., 2013). There are only two published randomized controlled trials of psycho-social interventions from Pakistan (Farooq et al., 2011; Nasr et al., 2009). We adapted CBT for psychosis in Pakistan (Naeem et al., 2014a,b,c), and found it to be effective in a preliminary study (Habib et al., 2014). The standard CBT for psychosis is normally delivered in 10 to 20 sessions (Naeem et al., 2014b). Through our previous work in Pakistan we know that brief intervention are preferred both by recipients (patients and caregivers) and providers in view of compelling demands on clinicians' time and limited resources in the health system allocated to psychiatric problems. Therefore, we adapted the therapy and developed a brief intervention. This paper describes a Randomized Controlled Trial to evaluate this brief Culturally adapted CBT for psychosis (CaCBTp).
subscales = .70), concurrent validity, and sensitivity to change in participants diagnosed with Schizophrenia. Insight was rated using the Schedule for Assessment of Insight (SAI) (David et al., 1992). The SAI rates three dimensions of insight; Treatment Adherence (SAI–TA), Recognition of Illness (SAI–RI) and Symptom Relabelling (SAI–SR). Symptom Relabelling involves the recognition of a psychotic symptom and the understanding that it is a pathological event. Each dimension comprises two or three questions which are scored on a 3-point scale from 0 (no insight) to 2 (good insight), with a maximum score of 24. The sub-scale totals are summed for a total insight score. 2.3. Setting Participants were recruited from 2 hospitals (Abbasi Shaheed Hospital and Karwan e Hayat Hospital) in Karachi, Pakistan. Karachi is one of the most populous cities in the world with a population of approximately 20 million. The city is divided into 18 towns. 2.4. Procedure
2. Methods 2.1. Trial design This was a randomized controlled trial, in which CaCBTp as an addon to treatment as usual (TAU) was compared with TAU, in participants with schizophrenia and related disorders attending mental health services in Karachi, Pakistan. The design of this study was approved by the Pakistan Association of Cognitive Therapist's (PACT) Ethics Committee (PACT_CAPRCT_120310). The trial was conducted in compliance with the Declaration of Helsinki and is registered at ClinicalTrials.gov Identifier: NCT01876056. 2.2. Instruments Data regarding demographic characteristics was collected. Psychopathology was measured using PANSS (Positive and Negative Syndrome Scale of Schizophrenia), PSYRATS (Psychotic Symptom Rating Scales), and the Schedule for Assessment of Insight (SAI). The above scales have been translated into Urdu using standard methodology and have been used previously (Habib et al., 2014). Independent raters were trained together at the start of the study to ensure inter-rater reliability. Primary outcome measure was reduction in positive symptoms measured by the PANSS Positive Symptoms Scale. Secondary outcome measures included negative symptoms and general psychopathology measured by PANSS, delusions and hallucinations measured by PSYRATS and Insight measured by SAI. The Positive and Negative Syndrome Scale of Schizophrenia (PANSS) (Kay et al., 1987) is a widely used, well established and comprehensive symptom rating scale measuring mental state. It has 30 items, each measured on a seven point rating scale. There are three sub-scales, Positive Symptoms; Negative Symptoms; and General Psychopathology. The Psychotic Symptom Rating Scale (PSYRATS)(Haddock et al., 1999) is a 17 item interviewer scored instrument which consist of 2 subscales (PSYRATS Auditory Hallucination; PSYRAT Delusion) which measures the severity of a number of dimensions of auditory hallucinations and delusions. The 11 item auditory hallucination sub-scale consists of items such as frequency, loudness, negative content, amount & intensity of distress and degree of disruption & control. The six item delusion sub-scale (PSYRATS delusion) consists of items such as amount & duration of pre-occupation, degree of conviction, amount & intensity of distress and disruption. All items are rated on a five point scale of increasing severity (0 = No problem to 4 = Maximum severity). The PSYRATS has demonstrated good inter rater reliability (intra class correlation [ICCS] for most item N .90), test re test reliability (ICCS for both
Participants referred by health professionals at the Hospitals received information about the study from a research assistant. After assessing for inclusion and adequately describing the study to the participants, written informed consent was obtained. Consenting participants were randomly allocated to one arm of the trial. A blind rater interviewed participants at baseline and end of therapy. The raters were psychology graduates that have received training in use of scales. Assessors were blind to allocation and were based in a separate location. 2.5. Participants Participants were eligible for inclusion, if the following criteria were met: (a) age 18–65 years; (b) living within traveling distance of the hospital; (c) having at least 5 years of education or living with a carer with at least 5 years of education; and, (d) with a diagnosis of Schizophrenia or a related disorder according to ICD10, RDC (International Classification of Diseases, 10th Edition, Research Diagnostic Criteria). They were excluded if they met any of the following criteria: (a) comorbid alcohol or substance dependence; (b) severe learning impairment; (c) problems due to an organic condition; and, (d) high levels of disturbed behaviour, or high risk of suicide or homicide. A total of 237 participants were referred (Fig. 1) and 180 fulfilled the criteria for inclusion in the study. We randomized 116 participants; 59 were randomized to the intervention arm (CaCBTp plus TAU) and 57 were randomized to the control (Treatment As Usual, TAU) arm. Each participant in CaCBTp plus TAU group received therapy over approximately 4 months. 2.6. Sample size A previous pilot study (Habib et al, 2014) found a standard deviation for the post-treatment scores of 5.8 in the control group, and 1.8 in the CaCBT plus TAU group. A difference of 15% of the pre-treatment values between groups, in the post-treatment PANSS positive symptoms score, was regarded to be of clinical importance. This equates to a difference of 3 units on the PANNS positive symptoms score scale. Using a 5% significance level and 90% power, it was calculated that 41 subjects per group will be required, 82 in total. It was expected that up to 30% of participants may drop-out of the study. To allow for this, a total of 116 participants were recruited into the study. 2.7. Randomization After completion of the assessment, participants were randomly assigned to either CaCBTp, plus TAU, or TAU group. The random
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
F. Naeem et al. / Schizophrenia Research xxx (2015) xxx–xxx
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Total Referrals (n=237)
Fulfilled Inclusion Criteria (n=180) Excluded (n=49)
Enrollment
Refused to participate (n=15) Randomized to Treatment (n=116)
Allocation
Allocated to treatment
Allocated to control group
group (n=59)
(n=57)
Drop out from Therapy (n=8) Analysis
Returned for follow up
Returned for follow up
assessments (n=53)
assessment (n=49)
Fig. 1. Consort flow diagram of the trial.
allocation lists were generated by a web-based automated randomization system (www.randomization.com). A numeric balance across conditions was guaranteed by performing the randomization separately for each research site, in random-permuted blocks of 6. The allocation list was kept in a remote secure location, and an independent person randomly allocated the included participants after they signed informed consent. In practice, those who performed research assessments were kept blind to randomization. The assessors started each assessment by stating that the participant should not talk about therapy or therapist. 2.8. Dropouts Participants who attended less than 3 sessions were considered to have dropped out from the therapy. More than two third participants of CaCBTp group attended all 6 sessions (n = 42), 5 attended five sessions, while 1 participant attended four, and 3 participant left after three sessions. Of the dropouts from therapy, 5 attended two sessions and 3 left after the first session. All the carers attended additional session for the family. We obtained contact numbers and consent from participants at baseline to contact them for the end of therapy assessments. Fourteen participants, who were unable to return for their final assessments, were contacted over phone (6 from CaCBTp plus TAU and 8 from TAU group) and follow-up assessments were arranged at home. 2.8.1. Interventions Therapy was provided according to a manualized treatment protocol (Kingdon and Turkington, 1994). Therapists were three psychology graduates with more than 5 year experience of working in mental health, who were trained by FN. Brief CBT for psychosis has been defined as CBTp delivered within 4 months using 6 to 10 sessions (Naeem et al., 2014b). An important part of cultural adaptation of the CBT for psychosis is the involvement of the family member (Habib et al., 2014). Families are heavily involved in patient's care, and serve as
the main caregivers to psychiatric patients in Pakistan, and, through our experience of adaptation of CBT for Pakistan, we understand that their involvement can enhance the acceptability of treatment. Therefore, this brief version consisted of 6 sessions for participant plus one session for the family. Every participant was accompanied by a carer who acted as co-therapist. Although therapy was provided flexibly, the sessions typically focused on following; 1. 2. 3. 4. 5. 6.
Formulation and psycho-education Normalization and introduction to stress vulnerability model Working with hallucinations Working with delusions Working with negative symptoms Termination work & relapse prevention
2.9. Cultural adaptation of CBTp Therapy was delivered using guidelines developed for cultural adaptation in Pakistan. These guidelines were developed in our preliminary work, in which CBTp was adapted using a series of qualitative studies. This consisted of series of qualitative studies similar to those we used for cultural adaptation of CBT for depression. During this preliminary work to adapt CaCBTp for use in Pakistan, we conducted a series of qualitative studies to explore the views of patients, their carers and the health professionals in this area. A total of 92 interviews were conducted by 3 psychologists. We conducted qualitative interviews with mental health professionals (n = 29) and patients (n = 33) and their carers (n = 30). The results of the mentioned studies highlighted the barriers in therapy (e.g. lack of awareness of therapy, family's involvement, traveling distance and expenses, and uncooperative family caregivers) as well as strengths while working with this patient group. Patients and their carers in Pakistan use a bio-psycho-spirituo-social model of illness. They seek help from various sources, including faith healers. Therapists
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
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F. Naeem et al. / Schizophrenia Research xxx (2015) xxx–xxx
make minor adjustments in therapy. Findings from these studies have been described in a separate paper (Naeem et al., 2014a,b,c). In our preliminary work, we observed that family members are involved actively in patient care in Pakistan, and therefore we involved the family members in the treatment plan from the beginning. Therapy started with the family's involvement and they shared the information to which the patient agreed, as well as being given the chance to ask questions. During the same session a key carer was identified with whom the therapist worked closely. The carer attended the sessions with the patient's consent and helped in therapy (e.g., with homework, if required). This approach has been found to be effective in delivering CBT for depression and for psychosis in Pakistan (Habib et al., 2014; Naeem et al., 2011, 2014a,b,c). An initial pilot project found this culturally adapted CBT for psychosis to be effective in Pakistan (Habib et al., 2014). In addition to one additional session for the whole family and the involvement of a carer throughout the therapy, other salient cultural adaptations that we incorporated in the CBT manual were: - A spiritual dimension was included in formulation, understanding and in therapy plan. - Urdu equivalents of CBT jargons were used in the therapy. - Culturally appropriate home work assignments were selected and participants were encouraged to attend even if they were unable to complete their homework. - Folk stories and examples relevant to the religious beliefs of the local population were used to clarify issues.
2.10. TAU group The Treatment As Usual (TAU) group received the treatment provided by the consultant psychiatrist in routine clinical care in their practice. This normally consists of prescribing antipsychotic medication as considered suitable by the treating psychiatrist and nursing care. At the completion of the research the participants who had been assigned to the TAU group were given the option of receiving CaCBTp. 2.11. Treatment fidelity Therapists were trained by FN in CBT for psychosis. They received regular online supervision through Skype by FN throughout the project. This supervision was provided weekly to the trained therapists. These therapists also received support locally by MG. This proved to be an effective method of supervision in our previous work. Supervision included discussion of therapy in progress, barriers, clarification of cultural issues and to ensure that therapists are following the therapy protocol. Additionally, randomly selected sessions were audio recorded and digital files were emailed to FN. The progress of the protocol was checked in the supervision sessions. A random selection of the taped therapy sessions was rated with the Revised Cognitive Therapy Scale (Blackburn et al., 2001).
2.12. Statistical analyses We followed the CONSORT guidelines for randomized controlled trials (Moher et al., 2005). Statistical analyses were carried out using an intention to treat, using SPSS v16. Both parametric and non parametric tests were carried out as and when appropriate to compare groups at baseline. A t test was used to compare groups, both paired and unpaired. SPSS frequency and descriptive commands were used to measure descriptive statistics. A linear regression was carried out to measure the differences between the two groups at the end of the therapy.
3. Results 3.1. Participant's description and characteristics A total of 59 participants were randomized to Treatment group and 57 to the Control group. The mean age of the participants was 31.3 years (SD = 7.8). Of the 119 participants, 46 (38.7%) were women; 72 (60.5%) were single, 32 (26.9%) were married and 15 (12.6%) were divorced/ widowed or widower; 55 (46.2%) were living in a joint family; they had received an average of 8.9 years of schooling; 42 (35.3%) were in employment and the average monthly family income of the group was 182.53 (SD = 82.73)$. The average duration of illness was 5.3 (SD = 3.5) years. 3.2. Baseline data The groups were compared on demographic characteristics and symptom measures at baseline. No significant differences were found (Table 1). 3.3. Symptom measure Participants in the Treatment group showed significantly greater improvements compared with TAU group at the end of the therapy, in positive and negative symptoms and general psychopathology (PANSS), delusions and hallucinations (PSYRATS) and insight (Table 2).
Table 1 Differences in demographic variables and psychopathology between the treatment and the control groups at the baseline, where figures are number(mean)SD for age, education, income and duration of current episode, while the rest are number(%).
Patients Age Gender (male) Education in years Marital status Single Married Divorced/widowed/widower Family income in US$ Employment status Employed Unemployed Self employed House wife Family system Joint/extended Nuclear Duration of illness in years Psychopathology PANSS Positive symptoms PANSS Negative symptoms PANSS General PSYRATS Delusions PSYRATS Hallucinations Insight Carer Age in years Gender (male) Education in years Relationship with patient Parents Siblings Partners Friends/other family
TAU (control group)
CaCBTp + TAU (treatment group)
p⁎
57(31.1)7.4 31(54.4%) 57(8.6)2.9
59(31.7)8.4 39(66.1%) 59(9.2)3.2
0.691 0.197 0.310
33(57.9%) 17(29.8%) 7(12.3%) 57(174.2) 68.9
38(64.4%) 15(25.4%) 6(10.2%) 59(195.1) 92.2
0.771
18(31.6%) 33(57.9%) 2(3.5%) 4(7.0%)
19(32.2%) 32(54.2%) 3(5.1%) 6(8.5%)
0.956
29(50.9%) 28(49.1%) 57(5.8)3.7
34(57.6%) 25(42.4%) 59(4.7)3.3
0.466 0.104
57(16.3)5.0 57(14.4)3.4 57(29.7)6.8 57(11.4)5.7 57(14.8)9.7 57(9.1)3.5
59(17.2)6.1 59(14.7)3.7 59(31.3)8.2 59(11.2)6.7 59(15.0)11.1 59(8.7)5.4
0.382 0.665 0.260 0.853 0.901 0.704
57(40.4) 11.7 28(49.1%) 57(9.2)3.0
59(42.2)14.1 25(42.4%) 59(10.4)3.4
0.451 0.466 0.046
26(45.6%) 15(26.3%) 12(21.1%) 4(7.0%)
31(52.5%) 16(27.1%) 6(10.2%) 6(10.0%)
0.431
0.171
P⁎ values using t test for age, education, income and duration of current episode and Chi square for the rest.
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
F. Naeem et al. / Schizophrenia Research xxx (2015) xxx–xxx
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Table 2 Differences between the treatment and control groups, both uncontrolled and controlled for initial differences. Analyses were carried out using a linear regression. Reduction in scores means improvement, except for insight scores where an increase indicates improvement. Differences uncontrolled
PANSS Positive symptoms PANSS Negative symptoms PANSS General PSYRATS Delusions PSYRATS Hallucinations Insight
Differences controlled for baseline
TAU (Control Group) Mean (SD)
CaCBTp + TAU (Treatment Group) Mean (SD)
Mean difference (CI)
P⁎
Mean difference (CI)
P⁎
16.9(5.5) 14.8(4.9) 30.0(8.4) 13.1(4.1) 15.2(7.4) 9.2(4.1)
13.1(4.7) 11.2(3.5) 23.7(6.2) 8.1(5.0) 10.4(7.2) 11.2 (4.1)
−3.8(−5.7, −1.9) −3.6(−5.1, −2.0) −6.4(−9.0, −3.7) −5.0(−6.7, −3.3) −4.8(−7.1, −2.0) 2.0(0.5, 3.5)
0.000 0.000 0.000 0.000 0.001 0.009
−4.1(−5.9−, −2.4) −3.7(−5.2, −2.2) −6.6(−9.3, −4.3) −5.0(−6.7, 3.3) −4.8(−7.4, −2.1) 2.1(0.6, 3.6)
0.000 0.000 0.000 0.000 0.000 0.007
⁎ p values were obtained using linear regression to compare the differences between two groups at follow-up, both with and without controlling for the baseline differences.
4. Discussion Literature on CBT for psychosis is scarce in developing countries and to the best of our knowledge at present there is no published RCT evaluating brief CBT for psychosis in LAMI Country settings. Our study shows that brief CBTp can be culturally adapted, and, is effective in improving psychopathology well as insight. The most common approach for enhancing efficiency of CBTp, is to abbreviate existing CBT treatments by reducing the number of treatment sessions (Naeem et al., 2014b). This has been tried in Western settings and has been found to be effective (Turkington et al., 2006). Although the RCT by Turkington (Turkington et al., 2006) included family session, it did not include family members during the therapy. Brevity has many clear advantages. Increased cost-effectiveness could make treatment accessible to more individuals in need of assistance. Participants enjoy rapid treatment gains, and this may also improve the credibility of the treatment and increase the motivation for further change (Bond and Dryden, 2005). We found brief CBT to be effective for depression and anxiety in Pakistan in an earlier trial (Naeem et al, accepted). Our brief CBT intervention however, involved a dedicated carer who worked as a co-therapist. The involvement of the carers is an essential part of the culturally adapted CBT. Families are keen to be part of the treatment and agreeing on a carer who attends the therapy can not only reduce family's anxieties, but also increases engagement and improves outcomes (Naeem et al, in press). Brief duration of treatment and delivery by psychology graduates with minimal training, but close supervision has a significant advantage in low resource settings. We know from our previous work that geographical distance can be a barrier to compliance with psychological treatment (Naeem et al., 2010). Fewer numbers of sessions may be helpful in partly overcoming that barrier. Lower cost in terms of therapist time is another advantage. Psychiatric services are available in major cities, and participants travel from around the country to seek treatment. Secondary care is the main setting for provision of psychiatric treatment in Pakistan, and main resource for training for mental health professionals. Development of a manual based treatment and incorporating it in the mainstream practice in secondary care will have long term impact on the future generations of trainees. Only a small number of RCTs have tested brief version of CBTp (Lewis et al., 2002; Turkington et al., 2002, 2006; Wykes et al., 2005). Therapy was delivered in these trials over 5–20 weeks and follow-up was carried out at 36 and 52 weeks. Different studies used varying number of sessions and formats for what was described as Brief CBTp. These included 6 individual sessions, plus 3 sessions for the carers delivered by nurses (Turkington et al., 2006), 5 week CBT program, which had 15– 20 h of therapy, plus 4 booster sessions (Lewis et al., 2002) and seven sessions of group CBTp (Wykes et al., 2005). The results of present study are comparable to Turkingtson et al.'s, study (Turkington et al., 2006) to evaluate brief CBT for psychosis. We have observed that both brief therapy and self help interventions are effective in this culture (Naeem et al., 2014a,b,c) (Naeem et al, in press). In the absence of research based evidence, we can only
offer possible explanations based on our experience of therapy and discussions with colleagues. First, there is pressure on participants to get better soon, due to financial reasons. This might serve as a motivating factor. Secondly, the participants from this culture are “therapy naïve”, in that in the absence of well developed psychological services, participants don't receive any therapies. In fact, based on our qualitative work, we found that most participants and their carers were not aware of non pharmacological interventions (Naeem et al., 2012, 2014a,b,c). Therefore, it is possible that when they engage for the first time in therapy, they find most of the newly learned techniques very useful. Third, involvement of families, and specially the main carer, participating in therapy as a co-therapist is a vital part of the interventions. These cotherapists not only made sure that the participant returns for therapy, but also helped them complete his home work.
5. Limitations This culturally adapted CBTp was tested in a small pilot in Lahore (Habib et al., 2014), while the current study was conducted in Karachi. Both Lahore and Karachi are big cities with relatively higher level of education. CaCBTp might need further adjustments when used for participants from rural background. A brief approach addresses distance from treating facilities and lower levels of education to some extent. There however, remains a need for further development and adaptation of these interventions to address these barriers in order to make it more accessible to participants with lower level of education. There is a need to conduct future trials with better methodology, for example to assess effectiveness of blinding, patients in both arms were receiving care as usual, which in Pakistan means, attending an outpatient clinic and taking medicines. This variable was not studied in details. There is also a need to conduct trials to compare brief versus standard therapy, and culturally adapted versus standard therapy. The brief nature of the intervention itself may have contributed to the effectiveness of the therapy, which needs to be addressed in future trials. The comparison of adapted versus standard CBT is specially important as currently there are no published trials of standard CBT from South Asia, specially of CBT for psychosis.
6. Conclusions This trial shows that it is feasible to offer brief CaCBTp along with medication to participants who can attend the service regularly in a low income country. The involvement of carers highlights an essential part of the therapy in this culture that can improve engagement and enhance the effect of therapy. The recruitment and retention in the trial were excellent. It lends support to acceptability of CaCBTp to both the participants and their families.
Funding body None.
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
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Contributors Farooq Naeem—trained and supervised CBT therapists and designed the study Sofiya Saeed—managed the overall project and co-supervised Muhammad Irfan—was involved in training of therapists and raters Tayyeba Kiran—provided therapy Nasir Mehmood—provided therapy Mirrat Gul—provided therapy Tariq Munshi—helped with analysis and write up Sohail Ahmad—carried out assessments Ajmal Kazmi—carried out assessments Nusrat Husain—supervised local therapists Saeed Farooq —was involved with cultural adaptation and refinement of adaptation Muhammad Ayub—carried out analysis David Kingdon—overall supervision of the study Conflict of interest None. Acknowledgements The Pakistan Association of Cognitive Therapists (PACT) provided personnel and organizational support for this trial.
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Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
Contents lists available at ScienceDirect
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Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country Farooq Naeem a,⁎, Sofiya Saeed b, Muhammad Irfan c, Tayyeba Kiran d, Nasir Mehmood d, Mirrat Gul e, Tariq Munshi a, Sohail Ahmad f, Ajmal Kazmi g, Nusrat Husain h, Saeed Farooq i,j, Muhammad Ayub a, David Kingdon k,l a
Department of Psychiatry, Queens University, Kingston, Canada Pakistan Association of Cognitive Therapists, Karachi, Pakistan c Department of Psychiatry and Behavioural Sciences, Peshawar Medical College, Peshawar, Pakistan d Pakistan Institute of Living and Learning, Karachi, Pakistan e Sir Ganga Ram Hospital, Lahore, Pakistan f Department of Psychiatry, Abbasi Shaheed Hospital, Karachi, Pakistan g Department of Psychiatry, Karwan e Hayat Hospital, Karachi, Pakistan h Institute of Brain, Behaviour and Mental Health, University of Manchester, UK i Department of Psychiatry, PGMI Lady Reading Hospital Peshawar, Pakistan j Staffordshire University, UK k Mental Health Care Delivery, University of Southampton, UK l Southern Health NHS Trust, UK b
a r t i c l e
i n f o
Article history: Received 24 November 2014 Received in revised form 17 February 2015 Accepted 21 February 2015 Available online xxxx Keywords: Schizophrenia Positive and negative symptoms Psychopathology Insight
a b s t r a c t Evidence for the effectiveness of Culturally adapted CBT for psychosis in Low And Middle Income Countries (LAMIC) is limited. Therefore, brief Culturally adapted CBT for psychosis (CaCBTp) targeted at symptoms of schizophrenia for outpatients plus treatment as usual (TAU) is compared with TAU. A total of 116 participants with schizophrenia were recruited from 2 hospitals in Karachi, Pakistan, and randomized into two groups with 1:1 allocation (CaCBTp plus TAU = 59, TAU = 57). A brief version of CaCBTp (6 individual sessions with the involvement of main carer, plus one session for the family) was provided over 4 months. Psychopathology was measured using Positive and Negative Syndrome Scale of Schizophrenia (PANSS), Psychotic Symptom Rating Scales (PSYRATS), and the Schedule for Assessment of Insight (SAI) at baseline and end of therapy. Participants in treatment group, showed statistically significant improvement in all measures of psychopathology at the end of the study compared with control group. Participants in treatment group showed statistically significant improvement in Positive Symptoms (PANSS, Positive Symptoms Subscale; p = 0.000), Negative Symptoms (PANSS, Negative Symptoms subscales; p = 0.000), Delusions (PSYRATS, Delusions Subscale; p = 0.000), Hallucinations (PSYRATS, Hallucination Subscale; p = 0.000) and Insight (SAI; p = 0.007). The results suggest that brief, Culturally adapted CBT for psychosis can be an effective treatment when provided in combination with TAU, for patients with schizophrenia in a LAMIC setting. This is the first trial of CBT for psychosis from outside the western world. These findings need replicating in other low and middle income countries. © 2015 Elsevier B.V. All rights reserved.
1. Introduction Cognitive Behavioural Therapy for psychosis (CBTp) is an evidencebased adjunct to medication in treating schizophrenia, and is recommended by National Treatment Guidelines in High Income Countries (APA, 2006; NICE, 2009). Cognitive Behaviour Therapy like other modern therapies was developed in the West, and is therefore underpinned by the Western cultural values. The explanatory models of illness are ⁎ Corresponding author. E-mail address: [email protected] (F. Naeem).
often rooted in local cultural and religious beliefs and values, which need to be addressed in any psychosocial intervention as these play a very important role in help seeking and health-related behaviours (Joel et al., 2003; Kleinman, 1980; Lloyd et al., 1998). There is evidence to suggest that people in Pakistan can attribute spiritual causes to psychotic symptoms (Zafar et al., 2008), and are more likely to consider seeking help from faith healers, compared with their western counterparts (Furnham et al., 2008). Therefore, it has been recommended that CBT needs cultural adaptation before its application in Non Western culture (Hays, 2009; Rathod and Kingdon, 2009). Our work in Pakistan using mixed methods research to culturally adapt CBT for psychosis
http://dx.doi.org/10.1016/j.schres.2015.02.015 0920-9964/© 2015 Elsevier B.V. All rights reserved.
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
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has shown that numerous adjustments need to be made for CBT to be acceptable, accessible and effective (Naeem et al., 2009a,b, 2010, 2011, 2012). There is currently no published RCT of CBTp from Low and Middle Income Countries (LAMIC). There is at least one study from a High Income Country in which CBTp was culturally adapted for ethnic minority participants (Rathod et al., 2013). There are only two published randomized controlled trials of psycho-social interventions from Pakistan (Farooq et al., 2011; Nasr et al., 2009). We adapted CBT for psychosis in Pakistan (Naeem et al., 2014a,b,c), and found it to be effective in a preliminary study (Habib et al., 2014). The standard CBT for psychosis is normally delivered in 10 to 20 sessions (Naeem et al., 2014b). Through our previous work in Pakistan we know that brief intervention are preferred both by recipients (patients and caregivers) and providers in view of compelling demands on clinicians' time and limited resources in the health system allocated to psychiatric problems. Therefore, we adapted the therapy and developed a brief intervention. This paper describes a Randomized Controlled Trial to evaluate this brief Culturally adapted CBT for psychosis (CaCBTp).
subscales = .70), concurrent validity, and sensitivity to change in participants diagnosed with Schizophrenia. Insight was rated using the Schedule for Assessment of Insight (SAI) (David et al., 1992). The SAI rates three dimensions of insight; Treatment Adherence (SAI–TA), Recognition of Illness (SAI–RI) and Symptom Relabelling (SAI–SR). Symptom Relabelling involves the recognition of a psychotic symptom and the understanding that it is a pathological event. Each dimension comprises two or three questions which are scored on a 3-point scale from 0 (no insight) to 2 (good insight), with a maximum score of 24. The sub-scale totals are summed for a total insight score. 2.3. Setting Participants were recruited from 2 hospitals (Abbasi Shaheed Hospital and Karwan e Hayat Hospital) in Karachi, Pakistan. Karachi is one of the most populous cities in the world with a population of approximately 20 million. The city is divided into 18 towns. 2.4. Procedure
2. Methods 2.1. Trial design This was a randomized controlled trial, in which CaCBTp as an addon to treatment as usual (TAU) was compared with TAU, in participants with schizophrenia and related disorders attending mental health services in Karachi, Pakistan. The design of this study was approved by the Pakistan Association of Cognitive Therapist's (PACT) Ethics Committee (PACT_CAPRCT_120310). The trial was conducted in compliance with the Declaration of Helsinki and is registered at ClinicalTrials.gov Identifier: NCT01876056. 2.2. Instruments Data regarding demographic characteristics was collected. Psychopathology was measured using PANSS (Positive and Negative Syndrome Scale of Schizophrenia), PSYRATS (Psychotic Symptom Rating Scales), and the Schedule for Assessment of Insight (SAI). The above scales have been translated into Urdu using standard methodology and have been used previously (Habib et al., 2014). Independent raters were trained together at the start of the study to ensure inter-rater reliability. Primary outcome measure was reduction in positive symptoms measured by the PANSS Positive Symptoms Scale. Secondary outcome measures included negative symptoms and general psychopathology measured by PANSS, delusions and hallucinations measured by PSYRATS and Insight measured by SAI. The Positive and Negative Syndrome Scale of Schizophrenia (PANSS) (Kay et al., 1987) is a widely used, well established and comprehensive symptom rating scale measuring mental state. It has 30 items, each measured on a seven point rating scale. There are three sub-scales, Positive Symptoms; Negative Symptoms; and General Psychopathology. The Psychotic Symptom Rating Scale (PSYRATS)(Haddock et al., 1999) is a 17 item interviewer scored instrument which consist of 2 subscales (PSYRATS Auditory Hallucination; PSYRAT Delusion) which measures the severity of a number of dimensions of auditory hallucinations and delusions. The 11 item auditory hallucination sub-scale consists of items such as frequency, loudness, negative content, amount & intensity of distress and degree of disruption & control. The six item delusion sub-scale (PSYRATS delusion) consists of items such as amount & duration of pre-occupation, degree of conviction, amount & intensity of distress and disruption. All items are rated on a five point scale of increasing severity (0 = No problem to 4 = Maximum severity). The PSYRATS has demonstrated good inter rater reliability (intra class correlation [ICCS] for most item N .90), test re test reliability (ICCS for both
Participants referred by health professionals at the Hospitals received information about the study from a research assistant. After assessing for inclusion and adequately describing the study to the participants, written informed consent was obtained. Consenting participants were randomly allocated to one arm of the trial. A blind rater interviewed participants at baseline and end of therapy. The raters were psychology graduates that have received training in use of scales. Assessors were blind to allocation and were based in a separate location. 2.5. Participants Participants were eligible for inclusion, if the following criteria were met: (a) age 18–65 years; (b) living within traveling distance of the hospital; (c) having at least 5 years of education or living with a carer with at least 5 years of education; and, (d) with a diagnosis of Schizophrenia or a related disorder according to ICD10, RDC (International Classification of Diseases, 10th Edition, Research Diagnostic Criteria). They were excluded if they met any of the following criteria: (a) comorbid alcohol or substance dependence; (b) severe learning impairment; (c) problems due to an organic condition; and, (d) high levels of disturbed behaviour, or high risk of suicide or homicide. A total of 237 participants were referred (Fig. 1) and 180 fulfilled the criteria for inclusion in the study. We randomized 116 participants; 59 were randomized to the intervention arm (CaCBTp plus TAU) and 57 were randomized to the control (Treatment As Usual, TAU) arm. Each participant in CaCBTp plus TAU group received therapy over approximately 4 months. 2.6. Sample size A previous pilot study (Habib et al, 2014) found a standard deviation for the post-treatment scores of 5.8 in the control group, and 1.8 in the CaCBT plus TAU group. A difference of 15% of the pre-treatment values between groups, in the post-treatment PANSS positive symptoms score, was regarded to be of clinical importance. This equates to a difference of 3 units on the PANNS positive symptoms score scale. Using a 5% significance level and 90% power, it was calculated that 41 subjects per group will be required, 82 in total. It was expected that up to 30% of participants may drop-out of the study. To allow for this, a total of 116 participants were recruited into the study. 2.7. Randomization After completion of the assessment, participants were randomly assigned to either CaCBTp, plus TAU, or TAU group. The random
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
F. Naeem et al. / Schizophrenia Research xxx (2015) xxx–xxx
3
Total Referrals (n=237)
Fulfilled Inclusion Criteria (n=180) Excluded (n=49)
Enrollment
Refused to participate (n=15) Randomized to Treatment (n=116)
Allocation
Allocated to treatment
Allocated to control group
group (n=59)
(n=57)
Drop out from Therapy (n=8) Analysis
Returned for follow up
Returned for follow up
assessments (n=53)
assessment (n=49)
Fig. 1. Consort flow diagram of the trial.
allocation lists were generated by a web-based automated randomization system (www.randomization.com). A numeric balance across conditions was guaranteed by performing the randomization separately for each research site, in random-permuted blocks of 6. The allocation list was kept in a remote secure location, and an independent person randomly allocated the included participants after they signed informed consent. In practice, those who performed research assessments were kept blind to randomization. The assessors started each assessment by stating that the participant should not talk about therapy or therapist. 2.8. Dropouts Participants who attended less than 3 sessions were considered to have dropped out from the therapy. More than two third participants of CaCBTp group attended all 6 sessions (n = 42), 5 attended five sessions, while 1 participant attended four, and 3 participant left after three sessions. Of the dropouts from therapy, 5 attended two sessions and 3 left after the first session. All the carers attended additional session for the family. We obtained contact numbers and consent from participants at baseline to contact them for the end of therapy assessments. Fourteen participants, who were unable to return for their final assessments, were contacted over phone (6 from CaCBTp plus TAU and 8 from TAU group) and follow-up assessments were arranged at home. 2.8.1. Interventions Therapy was provided according to a manualized treatment protocol (Kingdon and Turkington, 1994). Therapists were three psychology graduates with more than 5 year experience of working in mental health, who were trained by FN. Brief CBT for psychosis has been defined as CBTp delivered within 4 months using 6 to 10 sessions (Naeem et al., 2014b). An important part of cultural adaptation of the CBT for psychosis is the involvement of the family member (Habib et al., 2014). Families are heavily involved in patient's care, and serve as
the main caregivers to psychiatric patients in Pakistan, and, through our experience of adaptation of CBT for Pakistan, we understand that their involvement can enhance the acceptability of treatment. Therefore, this brief version consisted of 6 sessions for participant plus one session for the family. Every participant was accompanied by a carer who acted as co-therapist. Although therapy was provided flexibly, the sessions typically focused on following; 1. 2. 3. 4. 5. 6.
Formulation and psycho-education Normalization and introduction to stress vulnerability model Working with hallucinations Working with delusions Working with negative symptoms Termination work & relapse prevention
2.9. Cultural adaptation of CBTp Therapy was delivered using guidelines developed for cultural adaptation in Pakistan. These guidelines were developed in our preliminary work, in which CBTp was adapted using a series of qualitative studies. This consisted of series of qualitative studies similar to those we used for cultural adaptation of CBT for depression. During this preliminary work to adapt CaCBTp for use in Pakistan, we conducted a series of qualitative studies to explore the views of patients, their carers and the health professionals in this area. A total of 92 interviews were conducted by 3 psychologists. We conducted qualitative interviews with mental health professionals (n = 29) and patients (n = 33) and their carers (n = 30). The results of the mentioned studies highlighted the barriers in therapy (e.g. lack of awareness of therapy, family's involvement, traveling distance and expenses, and uncooperative family caregivers) as well as strengths while working with this patient group. Patients and their carers in Pakistan use a bio-psycho-spirituo-social model of illness. They seek help from various sources, including faith healers. Therapists
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
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make minor adjustments in therapy. Findings from these studies have been described in a separate paper (Naeem et al., 2014a,b,c). In our preliminary work, we observed that family members are involved actively in patient care in Pakistan, and therefore we involved the family members in the treatment plan from the beginning. Therapy started with the family's involvement and they shared the information to which the patient agreed, as well as being given the chance to ask questions. During the same session a key carer was identified with whom the therapist worked closely. The carer attended the sessions with the patient's consent and helped in therapy (e.g., with homework, if required). This approach has been found to be effective in delivering CBT for depression and for psychosis in Pakistan (Habib et al., 2014; Naeem et al., 2011, 2014a,b,c). An initial pilot project found this culturally adapted CBT for psychosis to be effective in Pakistan (Habib et al., 2014). In addition to one additional session for the whole family and the involvement of a carer throughout the therapy, other salient cultural adaptations that we incorporated in the CBT manual were: - A spiritual dimension was included in formulation, understanding and in therapy plan. - Urdu equivalents of CBT jargons were used in the therapy. - Culturally appropriate home work assignments were selected and participants were encouraged to attend even if they were unable to complete their homework. - Folk stories and examples relevant to the religious beliefs of the local population were used to clarify issues.
2.10. TAU group The Treatment As Usual (TAU) group received the treatment provided by the consultant psychiatrist in routine clinical care in their practice. This normally consists of prescribing antipsychotic medication as considered suitable by the treating psychiatrist and nursing care. At the completion of the research the participants who had been assigned to the TAU group were given the option of receiving CaCBTp. 2.11. Treatment fidelity Therapists were trained by FN in CBT for psychosis. They received regular online supervision through Skype by FN throughout the project. This supervision was provided weekly to the trained therapists. These therapists also received support locally by MG. This proved to be an effective method of supervision in our previous work. Supervision included discussion of therapy in progress, barriers, clarification of cultural issues and to ensure that therapists are following the therapy protocol. Additionally, randomly selected sessions were audio recorded and digital files were emailed to FN. The progress of the protocol was checked in the supervision sessions. A random selection of the taped therapy sessions was rated with the Revised Cognitive Therapy Scale (Blackburn et al., 2001).
2.12. Statistical analyses We followed the CONSORT guidelines for randomized controlled trials (Moher et al., 2005). Statistical analyses were carried out using an intention to treat, using SPSS v16. Both parametric and non parametric tests were carried out as and when appropriate to compare groups at baseline. A t test was used to compare groups, both paired and unpaired. SPSS frequency and descriptive commands were used to measure descriptive statistics. A linear regression was carried out to measure the differences between the two groups at the end of the therapy.
3. Results 3.1. Participant's description and characteristics A total of 59 participants were randomized to Treatment group and 57 to the Control group. The mean age of the participants was 31.3 years (SD = 7.8). Of the 119 participants, 46 (38.7%) were women; 72 (60.5%) were single, 32 (26.9%) were married and 15 (12.6%) were divorced/ widowed or widower; 55 (46.2%) were living in a joint family; they had received an average of 8.9 years of schooling; 42 (35.3%) were in employment and the average monthly family income of the group was 182.53 (SD = 82.73)$. The average duration of illness was 5.3 (SD = 3.5) years. 3.2. Baseline data The groups were compared on demographic characteristics and symptom measures at baseline. No significant differences were found (Table 1). 3.3. Symptom measure Participants in the Treatment group showed significantly greater improvements compared with TAU group at the end of the therapy, in positive and negative symptoms and general psychopathology (PANSS), delusions and hallucinations (PSYRATS) and insight (Table 2).
Table 1 Differences in demographic variables and psychopathology between the treatment and the control groups at the baseline, where figures are number(mean)SD for age, education, income and duration of current episode, while the rest are number(%).
Patients Age Gender (male) Education in years Marital status Single Married Divorced/widowed/widower Family income in US$ Employment status Employed Unemployed Self employed House wife Family system Joint/extended Nuclear Duration of illness in years Psychopathology PANSS Positive symptoms PANSS Negative symptoms PANSS General PSYRATS Delusions PSYRATS Hallucinations Insight Carer Age in years Gender (male) Education in years Relationship with patient Parents Siblings Partners Friends/other family
TAU (control group)
CaCBTp + TAU (treatment group)
p⁎
57(31.1)7.4 31(54.4%) 57(8.6)2.9
59(31.7)8.4 39(66.1%) 59(9.2)3.2
0.691 0.197 0.310
33(57.9%) 17(29.8%) 7(12.3%) 57(174.2) 68.9
38(64.4%) 15(25.4%) 6(10.2%) 59(195.1) 92.2
0.771
18(31.6%) 33(57.9%) 2(3.5%) 4(7.0%)
19(32.2%) 32(54.2%) 3(5.1%) 6(8.5%)
0.956
29(50.9%) 28(49.1%) 57(5.8)3.7
34(57.6%) 25(42.4%) 59(4.7)3.3
0.466 0.104
57(16.3)5.0 57(14.4)3.4 57(29.7)6.8 57(11.4)5.7 57(14.8)9.7 57(9.1)3.5
59(17.2)6.1 59(14.7)3.7 59(31.3)8.2 59(11.2)6.7 59(15.0)11.1 59(8.7)5.4
0.382 0.665 0.260 0.853 0.901 0.704
57(40.4) 11.7 28(49.1%) 57(9.2)3.0
59(42.2)14.1 25(42.4%) 59(10.4)3.4
0.451 0.466 0.046
26(45.6%) 15(26.3%) 12(21.1%) 4(7.0%)
31(52.5%) 16(27.1%) 6(10.2%) 6(10.0%)
0.431
0.171
P⁎ values using t test for age, education, income and duration of current episode and Chi square for the rest.
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
F. Naeem et al. / Schizophrenia Research xxx (2015) xxx–xxx
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Table 2 Differences between the treatment and control groups, both uncontrolled and controlled for initial differences. Analyses were carried out using a linear regression. Reduction in scores means improvement, except for insight scores where an increase indicates improvement. Differences uncontrolled
PANSS Positive symptoms PANSS Negative symptoms PANSS General PSYRATS Delusions PSYRATS Hallucinations Insight
Differences controlled for baseline
TAU (Control Group) Mean (SD)
CaCBTp + TAU (Treatment Group) Mean (SD)
Mean difference (CI)
P⁎
Mean difference (CI)
P⁎
16.9(5.5) 14.8(4.9) 30.0(8.4) 13.1(4.1) 15.2(7.4) 9.2(4.1)
13.1(4.7) 11.2(3.5) 23.7(6.2) 8.1(5.0) 10.4(7.2) 11.2 (4.1)
−3.8(−5.7, −1.9) −3.6(−5.1, −2.0) −6.4(−9.0, −3.7) −5.0(−6.7, −3.3) −4.8(−7.1, −2.0) 2.0(0.5, 3.5)
0.000 0.000 0.000 0.000 0.001 0.009
−4.1(−5.9−, −2.4) −3.7(−5.2, −2.2) −6.6(−9.3, −4.3) −5.0(−6.7, 3.3) −4.8(−7.4, −2.1) 2.1(0.6, 3.6)
0.000 0.000 0.000 0.000 0.000 0.007
⁎ p values were obtained using linear regression to compare the differences between two groups at follow-up, both with and without controlling for the baseline differences.
4. Discussion Literature on CBT for psychosis is scarce in developing countries and to the best of our knowledge at present there is no published RCT evaluating brief CBT for psychosis in LAMI Country settings. Our study shows that brief CBTp can be culturally adapted, and, is effective in improving psychopathology well as insight. The most common approach for enhancing efficiency of CBTp, is to abbreviate existing CBT treatments by reducing the number of treatment sessions (Naeem et al., 2014b). This has been tried in Western settings and has been found to be effective (Turkington et al., 2006). Although the RCT by Turkington (Turkington et al., 2006) included family session, it did not include family members during the therapy. Brevity has many clear advantages. Increased cost-effectiveness could make treatment accessible to more individuals in need of assistance. Participants enjoy rapid treatment gains, and this may also improve the credibility of the treatment and increase the motivation for further change (Bond and Dryden, 2005). We found brief CBT to be effective for depression and anxiety in Pakistan in an earlier trial (Naeem et al, accepted). Our brief CBT intervention however, involved a dedicated carer who worked as a co-therapist. The involvement of the carers is an essential part of the culturally adapted CBT. Families are keen to be part of the treatment and agreeing on a carer who attends the therapy can not only reduce family's anxieties, but also increases engagement and improves outcomes (Naeem et al, in press). Brief duration of treatment and delivery by psychology graduates with minimal training, but close supervision has a significant advantage in low resource settings. We know from our previous work that geographical distance can be a barrier to compliance with psychological treatment (Naeem et al., 2010). Fewer numbers of sessions may be helpful in partly overcoming that barrier. Lower cost in terms of therapist time is another advantage. Psychiatric services are available in major cities, and participants travel from around the country to seek treatment. Secondary care is the main setting for provision of psychiatric treatment in Pakistan, and main resource for training for mental health professionals. Development of a manual based treatment and incorporating it in the mainstream practice in secondary care will have long term impact on the future generations of trainees. Only a small number of RCTs have tested brief version of CBTp (Lewis et al., 2002; Turkington et al., 2002, 2006; Wykes et al., 2005). Therapy was delivered in these trials over 5–20 weeks and follow-up was carried out at 36 and 52 weeks. Different studies used varying number of sessions and formats for what was described as Brief CBTp. These included 6 individual sessions, plus 3 sessions for the carers delivered by nurses (Turkington et al., 2006), 5 week CBT program, which had 15– 20 h of therapy, plus 4 booster sessions (Lewis et al., 2002) and seven sessions of group CBTp (Wykes et al., 2005). The results of present study are comparable to Turkingtson et al.'s, study (Turkington et al., 2006) to evaluate brief CBT for psychosis. We have observed that both brief therapy and self help interventions are effective in this culture (Naeem et al., 2014a,b,c) (Naeem et al, in press). In the absence of research based evidence, we can only
offer possible explanations based on our experience of therapy and discussions with colleagues. First, there is pressure on participants to get better soon, due to financial reasons. This might serve as a motivating factor. Secondly, the participants from this culture are “therapy naïve”, in that in the absence of well developed psychological services, participants don't receive any therapies. In fact, based on our qualitative work, we found that most participants and their carers were not aware of non pharmacological interventions (Naeem et al., 2012, 2014a,b,c). Therefore, it is possible that when they engage for the first time in therapy, they find most of the newly learned techniques very useful. Third, involvement of families, and specially the main carer, participating in therapy as a co-therapist is a vital part of the interventions. These cotherapists not only made sure that the participant returns for therapy, but also helped them complete his home work.
5. Limitations This culturally adapted CBTp was tested in a small pilot in Lahore (Habib et al., 2014), while the current study was conducted in Karachi. Both Lahore and Karachi are big cities with relatively higher level of education. CaCBTp might need further adjustments when used for participants from rural background. A brief approach addresses distance from treating facilities and lower levels of education to some extent. There however, remains a need for further development and adaptation of these interventions to address these barriers in order to make it more accessible to participants with lower level of education. There is a need to conduct future trials with better methodology, for example to assess effectiveness of blinding, patients in both arms were receiving care as usual, which in Pakistan means, attending an outpatient clinic and taking medicines. This variable was not studied in details. There is also a need to conduct trials to compare brief versus standard therapy, and culturally adapted versus standard therapy. The brief nature of the intervention itself may have contributed to the effectiveness of the therapy, which needs to be addressed in future trials. The comparison of adapted versus standard CBT is specially important as currently there are no published trials of standard CBT from South Asia, specially of CBT for psychosis.
6. Conclusions This trial shows that it is feasible to offer brief CaCBTp along with medication to participants who can attend the service regularly in a low income country. The involvement of carers highlights an essential part of the therapy in this culture that can improve engagement and enhance the effect of therapy. The recruitment and retention in the trial were excellent. It lends support to acceptability of CaCBTp to both the participants and their families.
Funding body None.
Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015
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Contributors Farooq Naeem—trained and supervised CBT therapists and designed the study Sofiya Saeed—managed the overall project and co-supervised Muhammad Irfan—was involved in training of therapists and raters Tayyeba Kiran—provided therapy Nasir Mehmood—provided therapy Mirrat Gul—provided therapy Tariq Munshi—helped with analysis and write up Sohail Ahmad—carried out assessments Ajmal Kazmi—carried out assessments Nusrat Husain—supervised local therapists Saeed Farooq —was involved with cultural adaptation and refinement of adaptation Muhammad Ayub—carried out analysis David Kingdon—overall supervision of the study Conflict of interest None. Acknowledgements The Pakistan Association of Cognitive Therapists (PACT) provided personnel and organizational support for this trial.
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Please cite this article as: Naeem, F., et al., Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country, Schizophr. Res. (2015), http://dx.doi.org/10.1016/j.schres.2015.02.015