Community Based Mental Health Screening and Referral

NCT ID: NCT06756165

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Mental Health Depression Anxiety Disorders Community Health Services Women's Health

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Arm

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.

Group Type EXPERIMENTAL

Mental health screening

Intervention Type 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.

Control Arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mental health screening

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Dr Jai Kumar Das

OTHER

Sponsor Role lead

Responsible Party

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Dr Jai Kumar Das

Associate Professor and Assistant Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aga Khan University

Karachi, Sinddh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 41130670 (View on PubMed)

Other Identifiers

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53600

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-10475-30776

Identifier Type: -

Identifier Source: org_study_id

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