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

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.

Design: A multicenter Randomised Control Trial to compare Treatment As Usual (TAU) plus the Culturally adapted Manual Assisted Psychological therapy (C-MAP) with TAU in patients with a recent history of self-harm.

There is a built in 12 months internal pilot phase with clear stop/go criteria to prove viability to proceed to a full trial across all the study sites.

Setting: Participants will be recruited from general practices, emergency departments and medical wards of participating hospitals.

Health Technologies being assessed: A culturally adapted brief psychological intervention, based on the principles of Cognitive Behavioural Therapy (CBT). The intervention has 6 sessions, approximately 50 minutes each, and its feasibility has previously been established.

Sample Size: This trial will use repetition of self-harm as its primary outcome measure because it is a strong predictor of completed suicide. Brown et al (2005) saw a reduction from 41.6% to 24.1% in the rate of repetition of self-harm over an 18 month period. The sample size calculation assumes an event rate of 27.7% in the control arm and 16.1% in the talking therapy (C-MAP) arm of the study, an ICC of 0.05 and a 75% follow-up rate. Under the these assumptions a sample of 624 randomised patients will be required for a cluster adjusted test of proportions to have 80% power to detect this difference assuming a 5% significance level.

Measurement: The statistical analysis of the primary outcome measure repetition of self-harm episode and binary secondary outcome measures will be based on a cluster adjusted test of proportions. Economic analysis will estimate costs of primary, secondary/tertiary health care use, Disability Adjusted Life Years (DALYs) and quality adjusted life years (QALYs). Qualitative methods will explore patient and professional experiences. We will use an established approach in order to understand what factors block and facilitate successful delivery of the programme.

Impact on service users: The overall objective of the trial is to bring about a reduction of self-harm, overall morbidity, a reduction in rates of suicide and a better quality of life. In low income countries there is a huge treatment gap and up to 9 out of 10 people with mental health difficulties do not receive appropriate treatment. Outcomes from our earlier studies provide a strong foundation to build on and aid the translation of research into action. There can be other wide ranging positive outcomes, including increased awareness, improvements in relationships and greater employment. It is suggested that therapies which enhance self-efficacy such as Cognitive Behavioural Therapy (CBT) may reduce relapse and recurrence rates of many mental disorders including depression and anxiety.
Community awareness: The participants understanding of mental health issues will improve. We have experience of promoting our research within the Pakistani community including presentations or seminars with community leaders, local Pakistani media (newspapers & radio), and promotional material in GP surgeries. The importance of addressing mental health difficulties promoted through general public awareness will guide people to seek early clinical help for their mental health problems.
Service users as co-researchers: We organise an annual course on the fundamentals of qualitative research methods at the Pakistan Institute of Learning and Living, service users are invited to attend this course. Service users on the advisory board were trained in research methods and will contribute to the qualitative analysis in the proposed trial. Our team has significant expertise in this area and we have trained over 20 users and carers in research methods. We know service users provide very helpful additional insights into the themes emerging from the data and contribute greatly to the interpretation of findings. We will continue to offer this training to service users and carers.
Impact on services: There is limited data available currently to guide treatment choices for clinicians in Pakistan. The outcome of this trial will have implications for the health services, in terms of helping to improve the organisation of care and interventions offered for patients who self-harm and thus improve the quality of health services with potential reduction in overall costs. One of the outputs of this study will be a portfolio of user-defined, evidence-based, manual assisted intervention; a resource pack and training programme on 'how to do it' for use across local health services. This trial will provide detailed clinical and cost-effectiveness analyses which will inform future research and national clinical practice guidelines. Together these data will be useful to inform planning of effective and culturally appropriate interventions in Pakistan.
Research and clinical capacity: There is limited research capacity in Pakistan if funded we will be able to train research assistants in robust research methods. There will be workshops on fundamentals of quantitative & qualitative research methods which will be open for aspiring academics from outside the research team. We have developed the curriculum and trained more than 200 clinicians in Tier-1 psychosocial interventions for severe mental illness. We have initiated discussions with the nursing schools and departments of psychology that if the results show that C-MAP is effective it should be included in the curriculum.
Impact on policy: Research from the Global Mental Health Group have recommended that scaling up services for people with mental disorders is the most important priority for global mental health. We have contacts with the ministry of health and once the trial is completed we will enter discussions to present the results to them to take this work towards implementation. We now have Professor Mukesh Kapila as part of the research team his tremendous experience will be of great value in this regard.