Supporting the mental health of women affected by floods in rural Pakistan: a pilot study
| ISRCTN | ISRCTN14389109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14389109 |
| Sponsor | Interactive Research and Development |
| Funders | National Institute for Health and Care Research, Queen Mary University of London |
- Submission date
- 23/10/2026
- Registration date
- 27/10/2026
- Last edited
- 27/10/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Floods in Pakistan cause not only physical harm but also significant psychological distress, particularly among women. This study aimed to pilot a low-cost, tailored intervention combining WHO-endorsed Psychological First Aid (PFA) and Problem Management Plus (PM+) in post-flood affected communities in Thatta, Sindh province, and assess feasibility through changes in health worker training outcomes and mental health outcomes of flood-affected women, alongside implementation experiences, perceived outcomes, and barriers and facilitators to delivery.
Who can participate?
Female health workers aged between 18-65 years, who can speak and understand Sindhi and Urdu languages, have at least completed Matriculation, and are actively working with flood-affected people in interior Sindh. Also, flood-affected women (known as Marvi Workers) would receive the intervention via convenience sampling by their local female health workers as part of their ongoing in-person visits. The inclusion criteria is female participants aged between 18-65 years, who could speak and understand Sindhi or Urdu, had directly or indirectly been affected by floods, and get a score of 20 or higher on the Kessler Psychological Distress Scale (K-10).
What does the study involve?
The study involve two phases. Phase 1 is a scoping visit to adapt the PFA and PM+ manuals, capacity-building training, and pre- and post-assessments of female health workers. Phase II involve recruitment of flood-affected women (Marvi Workers) with psychological distress and delivered four monthly tailored PFA and PM+ sessions. Changes in depression, anxiety, PTSD, and resilience scores were assessed. Focus group discussions with female health workers and in-depth interviews with Marvi Workers captured qualitative insights.
What are the possible benefits and risks of participating?
Potential benefits included improved mental wellbeing and coping skills. Risks were minimal and participants could withdraw at any time and were referred for further professional support if needed.
Where is the study run from?
The study was conducted in Thatta district, Sindh Province, Pakistan, and was coordinated through Interactive Research and Development (IRD Global) (Pakistan)
When is the study starting and how long is it expected to run for?
July 2023 to October 2023
Who is funding the study?
This study was funded by the National Institute for Health and Care Research (NIHR) (UK) through its Research and Innovation for Global Health Transformation (RIGHT) programme (grant number NIHR200824), using UK international development funding from the UK Government to support global health research. The study was supported through the PIECEs Small Scale Research Grant, administered by Queen Mary University of London (UK).
Who is the main contact?
Mehwish Dawood, dawoodm@oregonstate.edu
Contact information
Principal investigator, Scientific
Oregon State University, 1500 SW Jefferson Way
Corvallis
97331
United States of America
| Phone | N/A |
|---|---|
| dawoodm@oregonstate.edu |
Scientific, Public
New York University, 50 W 4th St
New York
10012
United States of America
| Phone | N/A |
|---|---|
| ahmed.aatika8@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Health services research, Prevention, Supportive care |
| Scientific title | Psychosocial support for women in post-flood settings: a mixed-methods pilot of community-based psychological first aid and problem management plus in rural Pakistan |
| Study objectives | The study objectives are to explore preliminary signals of change in: 1. The knowledge, skills, and mental health awareness and sensitivity of female health workers following capacity-building training in PFA and PM+ delivery. 2. Mental health outcomes (depression, anxiety, PTSD, and resilience) of flood-affected women following a tailored PFA and PM+ intervention delivered through female health workers. |
| Ethics approval(s) |
Approved 11/04/2023, Institutional Review Board of Interactive Research & Development (IRD) Global in Pakistan (4th Floor, Woodcraft Building, Plot 3 & 3-A, Sector 47, Korangi Creek Road, Karachi, 75190, Pakistan; N/A; info@ird.global), ref: IRD_IRB_2023_02_002 |
| Health condition(s) or problem(s) studied | Psychological distress, depression, and anxiety in flood-affected women in Sindh Province, Pakistan |
| Intervention | Participants are flood-affected women experiencing psychological distress residing in Thatta district, Sindh Province, Pakistan. This is a single-arm pilot study with no control group. Participants receive a culturally adapted combined intervention comprising Psychological First Aid (PFA) and Problem Management Plus (PM+), delivered by trained Lady Health Visitors (LHVs) from the community. The LHVs are recruited via convenience sampling from HANDS to receive capacity-building training on PFA and PM+. And the flood-affected women (Marvi Workers) are recruited to receive the intervention via convenience sampling by their local LHVs as part of their ongoing in-person visits. The tailored intervention combining the PFA and PM+ sessions includes: PFA component is delivered using the Look-Listen-Link framework to provide immediate psychosocial support and connect women to available resources. The PM+ component covers evidence-based strategies including stress management skills, and problem-solving techniques, behavioral activation through task-oriented activities and explore avenues for strengthening social support and developing new skills. The adapted intervention consists of four monthly sessions, each lasting 45 to 60 minutes, and session content from PM+ Session 5 (staying well and looking forward) is integrated into the final session. Participants complete standardized quantitative assessments at baseline and endline. A subset of participants also takes part in individual in-depth interviews (IDIs) and focus group discussions (FGDs) to explore their experiences of the intervention. All sessions and qualitative data collection are conducted in in-person in Sindhi and Urdu by female researchers and LHVs. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 28/10/2023 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | Marvi Workers (MWs): 1. Female participants aged between 18-65 years 2. Speak and understand Sindhi or Urdu 3. Directly or indirectly affected by flood 4. Score of 20 or higher on the Kessler Psychological Distress Scale (K-10) Lady Health Visitors (LHVs): 1. Aged between 18-65 years 2. Speak and understand Sindhi and Urdu languages 3. Have at least completed Matriculation 4. Actively working with flood-affected people in interior Sindh |
| Key exclusion criteria | 1. Individuals with severe mental illness or cognitive impairment 2. Unable to provide informed consent |
| Date of first enrolment | 04/07/2023 |
| Date of final enrolment | 31/07/2023 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
26/10/2026: Study's existence confirmed by the Institutional Review Board of Interactive Research & Development (IRD) Global.
