Community Based Mental Health Screening and Referral

NCT06756165 | Completed

• 2 other identifiers: 2024-10475-3077653600
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention

  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.

  Data will be collected at baseline and approximately 12 months after the intervention begins.

Secondary Outcomes (2)

• Anxiety Symptoms

  Assessed at baseline and 12 months after intervention initiation.

• Depression Symptoms

  Assessed at baseline and 12 months after intervention initiation..

Study Arms (2)

Intervention Arm

EXPERIMENTAL

This arm focuses on enhancing mental health through structured activities integrated into existing community and primary health services. Participants in this arm will receive additional support to address mental health challenges within the flood-affected communities of Dadu. The intervention leverages trained Lady Health Workers (LHWs) and healthcare staff at primary health centers to screen, manage and provide timely referrals.

Behavioral: Mental health screening

Control Arm

NO INTERVENTION

Participants in the control arm will receive the standard care currently provided in the study area, which includes routine health services delivered by community health workers and the healthcare system. The control arm serves as a comparison group, enabling an evaluation of the additional impact of the intervention on mental health outcomes, resilience, and community engagement.

Interventions

Mental health screening BEHAVIORAL

Participants in the intervention arm will receive a mental health screening, referral, and counselling program by trained LHWs and BHU staff. LHWs will screen 120-170 WRA using PHQ-2 and GAD-2. Screen-positive WRA will be referred to BHUs, where trained doctors will reassess them using PHQ-9 and GAD-7. Those with mild to moderate anxiety or mild to moderately severe depression will receive two counselling sessions (initial and follow-up), each lasting at least 20 minutes, covering psychoeducation, awareness, and coping strategies. Severe cases will be referred to tertiary care for specialized mental health services. Mild cases will be advised to join resilience-building sessions. All WRA will attend two of three monthly group sessions by LHWs (20-25 WRA, 2 hours each), focusing on mental health literacy and coping strategies, including those related to climate change stressors like floods.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Only individuals who self-identify as female are eligible to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Dr Jai Kumar Das: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sinddh, 75300, Pakistan

Location

Related Publications (1)

• Das JK, Gaffey MF, Ansari ZN, Mirani M, Tabassum F, Niaz M, Siddiqui A, Rabbani F, Rizvi A, Ahmed I, Khan M, Bhutta ZA. Community-based mental health screening & referral for flood-affected women in rural Pakistan: an intervention feasibility study protocol. BMJ Open. 2025 Oct 23;15(10):e104759. doi: 10.1136/bmjopen-2025-104759.

  PMID: 41130670 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor and Assistant Director

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 1, 2025
• Study Start: January 15, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

PA (1)