Trial · NCT07890896
Improving Women's Mental Health Through Tele-based Wellbeing Centres in Bangladesh.
NCT07890896, Not applicable, Recruiting, International Centre for Diarrhoeal Disease Research, Bangladesh
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Women's Mental Health Through Tele-based Wellbeing Centres in Bangladesh. Trials, record NCT07890896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Women's Mental Health Through Tele-based Wellbeing Centres in Bangladesh.
- NCT number
- NCT07890896
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 1,200 participants, estimated
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Conditions
- Depression, Anxiety
- Interventions
- Tele-counselling, In-person counselling
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Depressive Symptom | From enrollment to the end of treatment at 32 weeks | Depressive Symptom: Will be measured using the validated Patient Health Questionnaire-9 (PHQ-9) in Bangladesh context, a widely 9-item scale evaluating the severity of depressive symptoms over the past two weeks. The scale consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), yielding a total score range of 0 to 27. Symptom severity is categorised using established clinical cut-off values: 0-4 (mild), 5-9 (moderate), 10-14 (moderately severe), and 15-19 (moderately severe), 20-27 (severe) depression. |
| Primary | Anxiety Symptom | From enrollment to the end of treatment at 32 weeks | Anxiety Symptom: Will be measured using the validated Generalised Anxiety Disorder-7 (GAD-7) scale in Bangladesh context, a 7-item instrument that reliably captures symptoms of clinical anxiety. The scale consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day), yielding a total score range of 0 to 21. Anxiety severity is categorized using the following cut-off values: 0-4 (mild), 5-9 (moderate), 10-14 (moderate), and 15-21 (severe) anxiety. |
| Secondary | Health-Related Quality of Life | From enrollment to the end of treatment at 32 weeks | Will be measured via the WHOQOL-BREF, validated in the Bangladesh context, a standardised and globally recognised instrument developed by World Health Organisation (WHO)-WHOQOL Group, comprising four dimensions (physical health, psychological, social relationships, and environment). This instrument consists of 26 items rated on a 1 to 5 scale, which includes two independent items assessing overall perception of quality of life and general health, the remaining 24 items compute the four domain scores . The raw domain scores are derived from the mean score of items within each domain and will be transformed to either a 4-20 scale (to be comparable with the full WHOQOL-100) or a 0-100 scale to facilitate interpretation and statistical analysis. |
| Secondary | Common Presentation of Conditions | From enrollment to the end of treatment at 32 weeks | MH GAP common presentation of conditions and diagnosis developed and validated by World Health Organization in Bangladesh context will be utilised by psychologist (during first and follow-up visits) of both arms for identifying usual conditions of depression, psychosis, bipolar disorder, epilepsy, mental health disorders, dementia, substance use disorders, and suicidal/self-harm ideation. |
| Secondary | Wellbeing Index | From enrollment to the end of treatment at 32 weeks | Will be measured via the validated World Health Organization-Five Well-Being Index (WHO-5) in Bangladesh context, designed to measure subjective psychological well-being over the past two weeks of women. This tool will be administered by psychologist of both arms during follow-up visits. The raw score of this scale ranges from zero to 25, zero representing worst possible mental well-being and 25 representing best possible mental well-being. |
| Secondary | Psychological Distress | From enrollment to the end of treatment at 32 weeks | Will be measured using the validated General Health Questionnaire (GHQ-12) in the Bangladesh context, a widely used 12-item screening tool designed to assess overall psychological distress and detect non-psychotic mental health problems among participants. Score in GHQ-12 ranges from 0-12, where 0-3 refers normal psychological condition and 4-12 score refers to have potential psychological distress. |
| Secondary | Gender-Based Violence (GBV) Exposure (Baseline T0 & Follow-up Period T1, T2, T3) | From enrollment to the end of treatment at 32 weeks | Exposure to gender-based violence will be measured using the standardised World Health Organization (WHO) Violence Against Women instrument. This globally recognised gold-standard tool systematically assesses partner-controlling behaviors, the frequency and severity of emotional, physical, and sexual violence, as well as the resulting impacts, injuries, and experiences of non-partner violence. * Baseline Assessment (T0): The full, comprehensive WHO instrument will be administered once at baseline (T0) only by a trained FRA. This baseline module captures controlling behaviors, lifetime physical violence, lifetime sexual violence, non-partner sexual assault, childhood sexual abuse, and 12-month recall of spousal violence. * Follow-up Assessments (T1, T2, T3): To eliminate overlapping recall periods and avoid unnecessary participant burden, all lifetime, childhood, and 12-month recall questions are omitted from follow-up visits. At T1 (2 months), T2 (4 months), and T3 (6 months), FRAs wi |
| Secondary | Maternal Immunization Tracking Module (Baseline T0) | During Enrollment only | A specialized 6-8 item Maternal and Child Immunization Tracking Module will be administered once during baseline enrolment (T0) only by trained Field Research Assistants (FRAs) to tracks maternal vaccination history during the current or most recent pregnancy, specifically identifying the receipt of Td/tetanus, according to the DHS Mothers Health and Contextual Factors. Instead of tracking child immunization, the adopted module focuses on the mother's decision-making factors and explores her future preferences for integrating vaccinations directly into routine antenatal care (ANC) visits versus utilizing separate EPI centers. This comprehensive data allows us to evaluate whether clinical recovery from mental distress (improved PHQ-9/GAD-7) positively influences a mother's preventive healthcare uptake and her receptiveness to future maternal immunization programs. |
| Secondary | Implementation and Operational Costs | At the end of the study intervention | A direct cost comparison will be conducted by systematically tracking and evaluating the implementation and operational expenses associated with both intervention arms. This includes comparing the direct costs of the tele-counselling model (e.g., therapist time, electronic equipment, internet connectivity, and dedicated room establishment) against the standard in-person counselling modality to determine the financial feasibility and budget impact of scaling the Wellbeing Centre model. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07890896
GET https://conductscience.org/api/trials/v1/NCT07890896/registered