An interventional study of Tele-counselling and In-person counselling in Depression and Anxiety, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Recruiting at 2 sites in Bangladesh. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Not applicable, Interventional, and Treatment
Burden:
Women in Bangladesh face a high mental health burden, with 22% experiencing mental disorders compared to 16% of men. Access to face to face psychological care is limited by stigma, financial barriers, restricted mobility, and shortage of trained professionals, resulting in a major treatment gap.
Knowledge gap:
Evidence on tele mental health effectiveness mainly comes from high income countries. In Bangladesh, evidence is limited to observational studies, and it remains unclear whether tele counselling is as effective as in person care for women.
This randomized non-inferiority trial will evaluate whether tele counselling can achieve comparable outcomes to face to face care. Findings will support policy decisions and scale up of accessible mental health services for women in Bangladesh, aligned national, global and institutional goals.
Hypothesis (if any):
1. Tele based counselling through WBC is hypothesised to be non-inferior to in person counselling in improving women's mental health outcomes, quality of life, and overall wellbeing, with comparable acceptability, accessibility, and usefulness.
Objectives:
This study aims to evaluate whether tele based counselling through Wellbeing Centres is a clinically non-inferior and feasible alternative to in person counselling for improving women's mental health and quality of life in Bangladesh.
Methods:
The investigators propose a two-arm randomized controlled non-inferiority trial among 1200 women with moderate to severe depression or anxiety. Participants will be randomized to tele counselling through Wellbeing Centres or standard face to face counselling using identical protocols. Outcomes including PHQ-9, GAD-7, WHOQOL-BREF, WHO-5, and GHQ-12 will be assessed at baseline and 2, 4, and 6 months. Quantitative and qualitative analyses will evaluate clinical effectiveness, feasibility, acceptability, accessibility, usability and treatment experiences.
Outcome measures/variables:
Primary outcomes are changes in depression (PHQ-9) and anxiety (GAD-7) scores. Secondary outcomes include quality of life (WHOQOL-BREF), psychological distress (GHQ-12), mhGAP conditions, wellbeing (WHO-5), and service acceptability, accessibility, and usefulness. All measures will be assessed at baseline and at 2, 4, and 6 months.
This proposed study is a two-arm parallel-group, randomized controlled non-inferiority trial. The primary objective is to evaluate whether structured tele-counselling delivered through Wellbeing Centres is clinically non-inferior to standard face-to-face (in-person) counselling for women experiencing symptoms of depression and anxiety in Bangladesh. A total of 1200 adult women presenting with moderate or severe symptoms (screened using validated PHQ-9 and GAD-7 tools) across two selected healthcare facilities will be randomized in a 1:1 ratio to receive either remote tele-counselling or in-person counselling from a site-appointed psychologist. The two selected facilities are Dinajpur District Hospital and Matlab Dakshin Upazila Health Complex, and the within-facility 1:1 randomization will be executed independently within each hospital. To isolate the true effect of the delivery modality, both intervention arms will strictly utilise the exact same counselling manual, number of sessions, duration, and supervision structure. Quantitative clinical outcomes-specifically symptom reduction and quality of life improvements (measured via WHOQOL-BREF)-will be assessed during follow-ups at 2, 4, and 6 months post-intervention. The trial incorporates a qualitative component that utilises in-depth and key informant interviews with service users, their families, psychologists, and hospital authorities to comparatively explore treatment experiences, socio-cultural dimensions, and technological mediation of Cognitive Behavioural Therapy (CBT) models. Additionally, the study will evaluate baseline gender-based violence (GBV) exposure as a clinical moderator of mental health recovery, and establish baseline maternal/child immunization completeness and structural access barriers.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 204 studies on the registry; 30 are open to participants now.
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Exclusion Criteria -
Women will attend a private room at the facility's Wellbeing Centre and receive live counselling from a qualified psychologist through a secure video call platform.
Behavioral: Tele-counselling
Women will receive face to face counselling from a facility-based psychologist in a private room at the health facility.
Behavioral: In-person counselling
Structured, evidence-based psychological counselling delivered via a secure video call platform. The frequency of sessions is need-based (up to a maximum of four sessions), typically delivered over an 8 to 12-week period. This arm uses the exact same counselling manual, number of sessions, duration, and supervision structure as the in-person control arm to isolate the effect of the delivery modality.
Structured, evidence-based psychological counselling delivered face-to-face. The frequency of sessions is need-based (up to a maximum of four sessions), typically delivered over an 8 to 12-week period. This arm uses the exact same counselling manual, number of sessions, duration, and supervision structure as the tele-counselling experimental arm to isolate the effect of the delivery modality.
Depressive Symptom
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Anxiety Symptom
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Health-Related Quality of Life
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Common Presentation of Conditions
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Wellbeing Index
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Psychological Distress
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Gender-Based Violence (GBV) Exposure (Baseline T0 & Follow-up Period T1, T2, T3)
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
Time frame: From enrollment to the end of treatment at 32 weeks
Maternal Immunization Tracking Module (Baseline T0)
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.
Time frame: During Enrollment only
Implementation and Operational Costs
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.
Time frame: At the end of the study intervention
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD Sharing Description: In the future, anonymous or abstracted data collected from this study may be supplied to other researchers or independent research institutions exclusively for scientific purposes, to answer new research questions or be combined with other datasets. Access Criteria: Data sharing will not occur without explicit authorization and oversight from the Research Administration (RA) and Regulatory and Legal Affairs (R\&LA) departments of icddr,b. All personal identifying information will be completely removed prior to sharing.
Time frame: Data will be retained for a minimum of 10 years following project completion.
Access criteria: Anonymous or abstracted data may be supplied to other researchers or independent research institutions exclusively for scientific purposes, to answer new research questions or be combined with other datasets. Access to the data requires explicit authorization from the Research Administration (RA) and Regulatory and Legal Affairs (R\&LA) departments of icddr,b. All personal identifying information will be completely removed prior to sharing to maintain privacy and confidentiality.
Data sharing details ↗ · www.icddrb.org
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