An interventional study of Mental health screening in Mental Health, Depression and Anxiety Disorders, sponsored by Dr Jai Kumar Das. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Dr Jai Kumar Das · Not applicable, Interventional, and Other
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.
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.
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's enrollment of 4,800 is above the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Dr Jai Kumar Das is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Inclusion Criteria:
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
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.
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.
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.
Time frame: Data will be collected at baseline and approximately 12 months after the intervention begins.
Anxiety Symptoms
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.
Time frame: Assessed at baseline and 12 months after intervention initiation.
Depression Symptoms
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.
Time frame: Assessed at baseline and 12 months after intervention initiation..
Plan to share: Undecided — Data will be shared upon individual reasonable requests, subject to approval from the institute and funders, and following the establishment of a formal data transfer agreement.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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