Clinical trial NCT06756165: Community Based Mental Health Screening and Referral
Official title: Community-Based Mental Health Screening & Referral for Flood-Affected Women in Dadu: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Depression
Anxiety Disorders
Community Health Services
Women's Health
Keywords: Mental Health Screening
Flood-Affected Women
Mental Health Referral
Mental Health Support
Screening and Referral Program
Health Services Accessibility
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2025-01-01
Enrollment: 4800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will adopt a parallel, quasi-experimental design with women of reproductive age in flood-affected areas of Dadu district. Participants will be purposively assigned to intervention or control groups. The intervention will include screening using PHQ-2 and GAD-2, followed by PHQ-9 and GAD-7 if positive, group awareness sessions, and referral to BHUs for care by trained psychologists or medical officers. Severe cases will be referred to tertiary care. Services will be delivered by trained LHWs, with one-time transport support. The control group will receive standard care without the mental health intervention. Both groups will be assessed at baseline and endline to compare changes in mental health status, service use, and care-seeking behavior.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: Data will be collected at baseline and approximately 12 months after the intervention begins.
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: Assessed at baseline and 12 months after intervention initiation.
measure: Depression Symptoms
timeFrame: Assessed at baseline and 12 months after intervention initiation..
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sinddh
Study officials:
References: