A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial.

BACKGROUND: Self-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm. METHODS: This was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016). RESULTS: We screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (- 3.6 (- 4.9, - 2.4)), depression (- 7.1 (- 8.7, - 5.4)), hopelessness (- 2.6 (- 3.4, - 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention. CONCLUSIONS: Suicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.

Culturally adapted family intervention for schizophrenia in Pakistan: a feasibility study.

OBJECTIVES: To establish feasibility and acceptability of a Culturally adapted Family Intervention (CulFI) that was developed using an empirically derived conceptual framework in Pakistan. METHODS: A rater-blind, randomised trial to evaluate the feasibility and acceptability of delivering CulFI compared to treatment as usual in Karachi, Pakistan. Indicators of feasibility included evaluation of recruitment rates, retention and randomisation. We also evaluated the acceptability of the intervention and trial procedures. RESULTS: Excellent recruitment and retention rates informed the feasibility of the intervention. CulFI had more than a 90% participant attendance of 8-10 sessions and retained more than 90% who commenced in the intervention. Eighty percent of those who initially provided consent were willing to be randomised and the quality of CulFI was rated as good to excellent by 85.7% of participants. CONCLUSIONS: Importantly, this study determines that pathways into a psychosocial intervention can be established in Pakistan. A combination of factors contribute to low levels of access to psychiatric care including different explanatory models of illness, small numbers of trained staff, limited resources and reliance on traditional healers. These results support the feasibility, acceptability and merit of conducting a full-scale trial of CulFI in comparison with standard care.ClinicalTrials.gov Identifier: NCT02167347KEY POINTSThe significant treatment gap in LMICs leaves families providing much of the care for people with schizophrenia.There is limited evidence from LMICs supporting the effectiveness and feasibility of psychosocial interventions more broadly, and family interventions specifically.This study adds to the scarce literature and demonstrates that pathways into delivering psychosocial interventions can be established in Pakistan.The results of this trial support the feasibility and acceptability of a Culturally adapted Family Intervention (CulFI) for schizophrenia patients and their families in PakistanA full-scale trial of CulFI in comparison with standard care is warranted to determine clinical and cost-effectiveness.

A Qualitative Study to Explore Patients', Carers' and Health Professionals' Views to Culturally Adapt CBT for Psychosis (CBTp) in Pakistan.

BACKGROUND: Cognitive Behaviour Therapy (CBT) has an established evidence base and is recommended by the national organizations in United Kingdom and the United States. CBT remains under utilized in low and middle income countries. CBT was developed in the west and it has been suggested that it is underpinned by western values. It therefore follows that to make CBT accessible for non western clients, it needs adapting into a given culture. AIMS: Our aim was to develop guidelines for adapting CBT for psychosis in Pakistan by incorporating the views of the patients, their carers and mental health professionals. METHOD: We conducted a series of qualitative studies in Pakistan to adapt CBT for psychosis (a total of 92 interviews). The data were analyzed by systematic content and question analysis. Analysis started by identifying emerging themes and categories. Themes emerging from the analyses of interviews by each interviewer were compared and contrasted with others interviewers constantly. Triangulation of themes and concepts was undertaken to further compare and contrast the data from the different participating groups. RESULTS: The results of these studies highlighted the barriers in therapy as well as strengths while working with this patient group. Patients and their carers in Pakistan use a bio-psycho-spiritual-social model of illness. They seek help from various sources. Therapists make minor adjustments in therapy. CONCLUSIONS: The findings from this study will help therapists working with this client group using CBT for psychosis in Pakistan. These results need to be tested through controlled trials.

Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country.

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 4months. 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.

A multicentre randomised controlled trial of a carer supervised culturally adapted CBT (CaCBT) based self-help for depression in Pakistan.

BACKGROUND: Cognitive Behaviour Therapy (CBT) based self-help has been found to be effective for treating depression and anxiety. There is some evidence to suggest that CBT needs to be culturally adapted for it to be effective in non-Western cultures. CBT is not widely used in low and middle income countries and there is a need to test its effectiveness in different settings and formats, including self-help. METHODS: We describe a RCT of a Culturally adapted CBT (CaCBT) based self-help manual in Pakistan. The trial was conducted in psychiatry departments in three cities. Assessments were carried out at baseline and at 12 weeks, using Hospital Anxiety and Depression Scale, Bradford somatic Inventory and brief disability Questionnaire. RESULTS: At the end of the trial CaCBT based self-help was found to be effective against care as usual in reducing the symptoms of depression and anxiety, as well as somatic symptoms and disability. LIMITATIONS: This study was conducted only in secondary care and required either patient or a carer to be able to read and write. CONCLUSIONS: This is the first study outside West of a CBT based self-help intervention for depression. This study highlights the importance of using cost effective interventions in developing world in low intensity formats. Future studies should focus on trying these resources in different settings, like primary care, and with the use of audio/video or multimedia resources to improve compliance in patients with lower literacy.