UK - Department for Business, Energy and Industrial Strategy
Multicenter RCT to evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm
Project Data Last Updated: 10/11/2021
IATI Identifier: GB-GOV-13-FUND--GCRF-MR_N006062_1
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.Objectives
The study has both quantitative and qualitative components. The objectives of the quantitative study are: 1. To determine the clinical effectiveness over 1 year of the Culturally adapted Manual Assisted brief psychological intervention (C-MAP) on the following outcomes: a. Primary outcome: To assess the effectiveness of C-MAP compared to Treatment as Usual (TAU) as measured by repetition rates of self-harm at 12 months after randomization b. Secondary outcomes: 1. Suicidal ideation assessed using the Beck Scale for Suicidal ideation (BSI) 11. Participants feelings of hopelessness - assessed using the Beck Hopelessness Scale (BHS) 111. Participants severity of depression - assessed using the Beck Depression Inventory (BDI) 1V. Participants Health related quality of life - assessed using the EQ5-D V. Participants coping skills - assessed using the Coping Resource Inventory (CRI) V1. Participant satisfaction with services - assessed using the Client Satisfaction Questionnaire (CSQ) 2. To reliably determine the cost effectiveness over 1 year of the C-MAP intervention using the following measures: a. Costs of delivering the intervention vs TAU and societal cost savings in use of health services and work. b. Cost effectiveness - cost of change in primary outcome repetition rate of self-harm. c. Cost utility - cost of a Quality Adjusted Life Years (QALY) 3. To determine the generalisability of findings across a range of urban centres across Pakistan An exploratory study of the C-MAP intervention compared to TAU has already demonstrated a statistically significant effect of the intervention in reducing suicidal ideation (-3.4 (-6.2 to -0.5), p=0.019), depression (-4.7 (-9.3 to -0.1), p=0.044), hopelessness (-3.6 (-6.1 to -1.2), p=0.003), increasing coping skills (5.7 (1.6-9.9.), p=0.004) and improving health related quality of life (5.9 (0.8 to 11.1), p=0.022). The exploratory study looked at suicidal ideation rather than repetition of self-harm as the primary outcome measure, addressed short term outcomes to six months only, and was focused on 3 hospitals in one city (Karachi). All of these limitations will be addressed in this definitive trial which assesses outcome up to 1 year, and includes patients from hospitals and primary care across five urban centres across Pakistan. 4. Explore the mechanism of change using statistical models to examine change in process variables in relation to outcome variables/ process variables 5. To assess the characteristics of further episodes of self-harm as measured by the number of subsequent self-harm events, time to next event and severity of event as measured by the adapted Suicide Attempt Self-Injury Interview. The objectives of the qualitative study are: 1) To explore participant's views of the C-MAP psychological intervention 2) To identify reasons for continuing or not continuing with the study 3) To explore views of the General Practitioners (GP's)/Hospital clinicians on the C MAP psychological intervention and its impact on practice 4) To explore perspectives of therapists 5) To explore the views of other stake holders 6) Identify barriers and facilitators to use of intervention for staff and patients to inform implementation. The expected outputs of the study are: a) A manual assisted evidence based intervention - the C-MAP, ready for integration into the health services and the voluntary sector. b) Standardised training and supervision package - a resource pack and training programme on 'how to do it' for use across health services. The training package will include the manual along with evidence-based protocols that are acceptable, feasible and accessible to both providers and users of health services. c) Information Tool-kit - an information tool kit for the families and the wider community, this tool kit will be service user defined and will be used to increase the awareness in community workshops.
|Extending:||UK Research & Innovation|
|Funding:||UK - Department for Business, Energy and Industrial Strategy|
|Implementing:||The University of Manchester|
Sectors groups as a percentage of country budgets according to the Development Assistance Committee's classifications.
A comparison across six financial years of forecast spend and the total amount of money spent on the project to date.