Multicenter RCT to evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm

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Suicide is a serious global public health issue ranked amongst the leading causes of death in many countries. The worldwide rates of suicide have increased by 60% in the last 45 years, and the 1.8% total global burden of disease attributed to suicide in 1998 is expected to increase to 2.4% by 2020. The WHO Mental Health Action Plan 2013-2020 and all the member states have committed to work towards the global target of a 10% reduction in the suicide rate by 2020. WHO's Mental Health Gap Action Programme includes suicide as one of the priority conditions and the recent WHO report "Preventing suicide: a global imperative" calls for suicide prevention to be a high priority on the global public health agenda. More than 800 000 people across the world die due to suicide each year and for each suicide there are more than 20 people attempting suicide. Each suicide takes the life of the individual and has a tremendous effect on friends, family and the wider community. Up to 75% of all suicides occur in in low- and middle-income countries where resources and services are limited for treatment and support for people who need. There is a clear gap in the robust evaluation of culturally appropriate suicide prevention strategies in low and middle income countries. Individuals who have a history of self-harm are at much higher risk of dying by suicide than individuals who do not have such a history. The WHO recommends that offering them appropriate treatment should be a key component of all suicide prevention strategies. There are in excess of 100,000 acts of self-harm carried out in Pakistan annually. The aim of the proposed trial is to evaluate the clinical and cost-effectiveness of a culturally adapted psychological therapy (C-MAP) in patients with a history of self-harm. We carried out a study in Karachi to determine the effectiveness of a 6-8 session CBT-based intervention (C-MAP) in people who had recently self-harmed. The assessments were carried out at baseline, 3 & 6 months. There was a significant reduction from baseline in suicidal ideation, severity of depression and hopelessness in the intervention group compared to the Treatment as Usual (TAU) group at each follow up assessment. The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode. The proposed research will be conducted in Karachi, Lahore, Rawalpindi, Quetta and Peshawar. Participants will be randomized either to the Intervention (C-MAP) or TAU. The existing culturally adapted intervention (C-MAP) includes an evaluation of the self-harm episode, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies. The intervention will be delivered in six sessions over 12 weeks. Assessments will be conducted at baseline and at 3 months (end of intervention) 6 months and 12 months after randomisation. The outcome measures will include questionnaires to measure the repetition of self-harm, severity of suicidal ideation; depression; hopelessness; quality of life and coping resources. In addition, qualitative interviews and focus groups will provide rich information regarding the experiences of participants and therapists, which will inform the development of more effective and sensitive services for self-harm management. TAU will be standard routine care delivered by local medical, psychiatric and primary care services according to their clinical judgement. A record will be kept of any treatment received by each participant. This trial will provide detailed clinical and cost-effectiveness analyses for the management of self-harm which will inform future research and national clinical practice guidelines. We have established contacts with the ministry of health and once the trial is completed we will enter discussions to present the results to them and attempt to influence policy change.