Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan (PRIME-PK)

May 16, 2024 updated by: Pakistan Institute of Living and Learning

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Thatta, Sindh, Pakistan
        • District health facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mgGap-IG
MhGap-IG intervention to be delivered to depression and self-harm cohorts
Other: psychological interventions

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.

  1. Khushi Aur Khatoon - for the treatment of depression and anxiety
  2. Learning through Play Plus - 10-session group intervention that integrates parental information about child development and Cognitive Behavior Therapy
  3. 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.

Other Names:
  • mhGap-IG

What is the study measuring?

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
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
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
Time Frame: Change in scores from baseline to 3rd-month follow-up on PHQ-9
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
Time Frame: Change in scores from baseline to 3rd-month follow-up on GAD-7
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
Time Frame: Repetition of a self-harm episode from baseline to end of 3rd month post-baseline
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
Time Frame: Change in scores from baseline to 3rd-month follow-up on social support
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
Time Frame: Number of stressful events identified by each participant as present in last 12 months
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
Time Frame: Change in scores from baseline to 3rd-month follow-up on EQ-5D
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
Time Frame: Change in health service utilization from baseline to 3 month follow-up recorded through CSRI
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

April 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 11, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIME-PK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only anonymized data will be shared on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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