Community Based Mental Health Screening and Referral

Not Applicable

Not yet recruiting

• Conditions: Mental Health; Depression; Anxiety Disorders; Community Health Services; Women's Health

• Registration Number: NCT06756165
• Lead Sponsor: Dr Jai Kumar Das

Brief Summary

This feasibility study aims to evaluate the implementation of a community-based mental health screening, referral, and resilience-building intervention for flood-affected women of reproductive age (WRA) in a rural district of Dadu, Sindh, Pakistan. The quasi-experimental study uses a comparison group and involves training Lady Health Workers (LHWs) to conduct mental health screening using GAD-2 and PHQ-2 tools, refer screen-positive women to Basic Health Units (BHUs) for further assessment, and conduct group sessions on mental health awareness and climate resilience. BHU doctors will reassess referred women using GAD-7 and PHQ-9, provide psycho-counseling, and refer severe cases to tertiary care. The study will assess feasibility, acceptability, appropriateness, and effectiveness of the intervention to inform scalable mental health strategies for disaster-prone settings.

Detailed Description

This study evaluates the feasibility and implementation of a community-based mental health screening, referral, and resilience-building intervention for women of reproductive age (WRA) affected by the 2022 floods in the Dadu district of Sindh, Pakistan. The intervention engages Lady Health Workers (LHWs) to screen WRA using validated tools-GAD-2 and PHQ-2. Women scoring ≥3 on either scale will be referred to Basic Health Units (BHUs), where trained facility-based doctors will reassess them using the GAD-7 and PHQ-9 instruments. Based on the diagnosis, WRA with mild to moderate symptoms will receive two structured counseling sessions, while those with severe symptoms will be referred to tertiary care with logistical support.

In parallel, LHWs will conduct monthly group sessions to raise mental health awareness, address stigma, and build community resilience to climate change-related hazards such as flooding. These sessions, based on a standardized curriculum, are open to all WRA regardless of screening status and focus on stress management, coping strategies, and emotional support.

The study employs a quasi-experimental design with a comparison group across selected union councils. The intervention will be evaluated through baseline and end-line quantitative surveys as well as qualitative assessments via focus group discussions (FGDs) and in-depth interviews (IDIs). The primary outcomes include feasibility, acceptability, appropriateness, and awareness levels, while the secondary outcome assesses the effectiveness of the intervention in reducing symptoms of depression and anxiety.

The findings will guide future efforts to integrate mental health services into primary care and community-based disaster preparedness strategies in Pakistan and similar contexts.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-25
• Study First Posted: 2025-01-01
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-05-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4800

Inclusion Criteria

• Women of reproductive age (WRA) 18-49 years in the targeted area

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention	Data will be collected at baseline and approximately 12 months after the intervention begins.	A structured questionnaire will be used to assess the feasibility of implementing the community-based mental health screening, referral, and resilience-building intervention. It will be administered to Lady Health Workers (LHWs), health facility staff, and program implementers. The tool will assess recruitment success, retention rates, adherence to protocol, and challenges encountered during implementation.; Measurement Tool: A specifically designed feasibility assessment questionnaire.

Secondary Outcome Measures

Name	Time	Method
Anxiety Symptoms	Assessed at baseline and 12 months after intervention initiation.	Anxiety symptoms will be measured using the Generalized Anxiety Disorder-7 (GAD-7), a validated screening tool. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.; Measurement Tool: GAD-7 questionnaire.
Depression Symptoms	Assessed at baseline and 12 months after intervention initiation..	Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a standardized and validated tool. Scores range from 0 to 27, with higher scores reflecting greater severity.; Measurement Tool: PHQ-9 questionnaire.

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sinddh, Pakistan