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Clinical Trials/NCT05767840
NCT05767840
Active, not recruiting
Not Applicable

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

Pakistan Institute of Living and Learning1 site in 1 country40 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Pakistan Institute of Living and Learning
Enrollment
40
Locations
1
Primary Endpoint
Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Aims:

  1. To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and
  2. 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

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)

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
January 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred

Time Frame: Recruitment From First month of study to the end of thirst month of the study start date.

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

Secondary Outcomes

  • Oslo - 3 items social support scale(Change in scores from baseline to 3rd-month follow-up on social support)
  • Generalised Anxiety Disorder scale(Change in scores from baseline to 3rd-month follow-up on GAD-7)
  • Life Events Checklist(Number of stressful events identified by each participant as present in last 12 months)
  • Patient Health Questionnaire(Change in scores from baseline to 3rd-month follow-up on PHQ-9)
  • Client Services Receipt Inventory(Change in health service utilization from baseline to 3 month follow-up recorded through CSRI)
  • Deliberate Self-Harm Inventory(Repetition of a self-harm episode from baseline to end of 3rd month post-baseline)
  • EuroQoL-5 Dimensions(Change in scores from baseline to 3rd-month follow-up on EQ-5D)

Study Sites (1)

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