Mental HealthMeSHNCT06756165
Community Based Mental Health Screening and Referral
A study testing Mental health screening in people with Mental Health and Depression, run by Dr Jai Kumar Das at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Depression, Anxiety Disorders
- What is being tested?
- Mental health screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of reproductive age (WRA) 18-49 years in the targeted area
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-Based Mental Health Screening & Referral for Flood-Affected Women in Dadu: A Feasibility Study
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.
Read the 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.
- Being tested
- Mental health screening
- Keywords
- Mental Health Screening, Flood-Affected Women, Mental Health Referral, Mental Health Support, Screening and Referral Program, Health Services Accessibility
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental health screeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be collected at baseline and approximately 12 months after the intervention begins.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Assessed at baseline and 12 months after intervention initiation..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Jan 2025
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Jai Kumar Das
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor-investigator, Dr Jai Kumar Das, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756165
- Sponsor's protocol ID
- 2024-10475-30776
- Other IDs
- 53600
- Acronym
- MeSH
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 41130670
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Mental Health Screening & Referral for Flood-Affected Women in Dadu: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06756165
- Acronym / sponsor ID
- MeSH / 2024-10475-30776
- Keywords
- Mental Health Screening, Flood-Affected Women, Mental Health Referral, Mental Health Support, Screening and Referral Program, Health Services Accessibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,800 participants (actual)
- Lead sponsor
- Dr Jai Kumar DasUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Mental health screeningThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women of reproductive age (WRA) 18-49 years in the targeted area
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental health screeningParticipants 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. | Behavioural | Intervention Arm |
Primary outcome
Feasibility of Intervention
Time frame: 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.
2 secondary outcomes
Anxiety Symptoms
Time frame: Assessed at baseline and 12 months after intervention initiation.
Depression Symptoms
Time frame: Assessed at baseline and 12 months after intervention initiation..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 41130670Das 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental health screening in people with Mental Health and Depression, run by Dr Jai Kumar Das at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: Data will be collected at baseline and approximately 12 months after the intervention begins.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.