Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan

Study Overview
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Brief Summary
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Aims: To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and To describe its enabling intervention packages and components to be delivered at the Basic Health Units in Thatta district. The proposed study will be a pilot implementation with nested qualitative component. The study will also involve situational analysis for proposed study site and Theory of Change workshops with key stakeholders. This study is a replication of the methods used in the development of a district mental healthcare plan in Uganda (Kigozi et al., 2016).

Detailed Description
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Mental neurological and substance use (MNS) disorders contribute significantly to global burden of disease. The WHO Mental Health Action Programme (MhGAP) taking a life course approach has developed an intervention guide to scale up services in low and middle income countries (LMICs) focusing on priority mental health conditions in adults and older adults. The gap between the individuals in need of mental health interventions and those who actually receive such care remains very large. To reduce the treatment gap, the WHO Mental Health Action Plan (WHO, 2017) strongly recommended assessment, diagnosis and treatment of MNS in community settings and primary healthcare (PHC). Central to this agenda is the WHO Mental Health Gap Action Programme (mhGAP) and intervention guide (IG) (WHO, 2010) which is an evidence based tool. The proposed project aims to integrate the adapted WHO-mhGap-IG for depression, self-harm and suicide prevention into the community and primary settings in Thatta (situated in the province of Sindh, Pakistan). Depression and self-harm are selected priority conditions for the proposed study. In order to collect information and detailed cross-sectional data on health and factors that can influence health of Thatta district, a situational analysis tool will be used. Both one to one in-depth interviews as well as focus groups will be conducted with stakeholders to explore possible barriers and facilitators of testing the feasibility of adapted mhGap-IG for depression and self-harm in Thatta. Pilot study will be conducted using the mhGAP-Intervention Guide (mhGAP-IG) (two modules: Depression, self harm and suicide prevention)

Official Title
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Development and Pilot Testing of an Integrated Mental Healthcare Plan for Management of Depression and Self-harm in a Rural District (Thatta) in Pakistan

Conditions
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Depression, Self Harm

Intervention / Treatment
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* Other: psychological interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged 18 and above presenting to recruiting health facilities will be assessed by the research team for depression (positive) and/or history of self-harm (positive Exclusion Criteria: Patients below 18 years of age, Patients taking medication for/ having a diagnosis of substance abuse, severe mental/physical disability/ comorbidity, whereby they are unable to participate in the interview.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mgGap-IG<br>MhGap-IG intervention to be delivered to depression and self-harm cohorts | Other: psychological interventions<br>* mhGap-IG Depression and self-harm module. For participants identified as has having depression, following interventions will be offered depending on nature of the participants. Khushi Aur Khatoon - for the treatment of depression and anxiety Learning through Play Plus - 10-session group intervention that integrates parental information about child development and Cognitive Behavior Therapy Problem management Plus (PM+) - PM+ is for adults suffering from symptoms of common mental health problems , as well as self-identified practical problems. Cohort identified as having a recent history of self-harm will receive; Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention, adapted from a self-help guide called Life After Self-Harm.<br>* Other names: mhGap-IG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred | Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT | Recruitment From First month of study to the end of thirst month of the study start date. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire | This is a10 item questionnaire with a total score ranging from 1-4 indicates minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. A cut-off score of 10 and above indicate high likelihood of presence of depression. | Change in scores from baseline to 3rd-month follow-up on PHQ-9 | 
| Generalised Anxiety Disorder scale | This is a 7-item scale. GAD-7 total score for the seven items ranges from 0 to 21.0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. A cut-off score of 10 and above indicate high likelihood of presence of anxiety. | Change in scores from baseline to 3rd-month follow-up on GAD-7 | 
| Deliberate Self-Harm Inventory | DSHI will be used to collect information about episode of self-harm. is a 17-item self-report questionnaire developed to assess deliberate self-harm. It is behaviorally based and assesses aspects of deliberate self-harm such as frequency, severity, duration, and type of self-harming behavior | Repetition of a self-harm episode from baseline to end of 3rd month post-baseline | 
| Oslo - 3 items social support scale | Oslo-3 social support scale is a short three item rating scale. This scale assesses relationship with friends, family and neighbors. Each item is scored on a 5-point rating scale, and the total score ranges from 3 to 15, with high scores indicating greater level of support. | Change in scores from baseline to 3rd-month follow-up on social support | 
| Life Events Checklist | The domains that accounted for most of the life events and difficulties will be included and rated categorically as present or not in the previous 12 months. | Number of stressful events identified by each participant as present in last 12 months | 
| EuroQoL-5 Dimensions | This is a standardized instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) | Change in scores from baseline to 3rd-month follow-up on EQ-5D | 
| Client Services Receipt Inventory | Participants will be asked to give a detailed description of the use of health services (including the informal sector faith healers/Imams) in last 3 months. | Change in health service utilization from baseline to 3 month follow-up recorded through CSRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment gap, mental health, primary care, task shifting, mhGap, Pakistan