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

NCT05767840 | Active Not Recruiting DMC

• 1 other identifier: PRIME-PK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aims:

1. 1.To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and
2. 2.To describe its enabling intervention packages and components to be delivered at the Basic Health Units in Thatta district.

Conditions

Depression; Self Harm

Keywords

treatment gap; mental health; primary care; task shifting; mhGap; Pakistan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient Health Questionnaire

  Change in scores from baseline to 3rd-month follow-up on PHQ-9

• Generalised Anxiety Disorder scale

  Change in scores from baseline to 3rd-month follow-up on GAD-7

• Deliberate Self-Harm Inventory

  Repetition of a self-harm episode from baseline to end of 3rd month post-baseline

• Oslo - 3 items social support scale

  Change in scores from baseline to 3rd-month follow-up on social support

• Life Events Checklist

  Number of stressful events identified by each participant as present in last 12 months

Study Arms (1)

mgGap-IG

EXPERIMENTAL

MhGap-IG intervention to be delivered to depression and self-harm cohorts

Other: psychological interventions

Interventions

psychological interventions OTHER

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.

Also known as: mhGap-IG

mgGap-IG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

District health facility

Thatta, Sindh, Pakistan

Location

Related Publications (1)

• Kigozi FN, Kizza D, Nakku J, Ssebunnya J, Ndyanabangi S, Nakiganda B, Lund C, Patel V. Development of a district mental healthcare plan in Uganda. Br J Psychiatry. 2016 Jan;208 Suppl 56(Suppl 56):s40-6. doi: 10.1192/bjp.bp.114.153742. Epub 2015 Oct 7.

  PMID: 26447171 BACKGROUND

MeSH Terms

Conditions

Depression; Self-Injurious Behavior; Psychological Well-Being

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 14, 2023
• Study Start: February 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: January 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)