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DepressionNCT07890896

Improving Women's Mental Health Through Tele-based Wellbeing Centres in Bangladesh.

A study testing Tele-counselling and In-person counselling in people with Depression and Anxiety, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

1. 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. 2. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression, Anxiety
What is being tested?
Tele-counselling and In-person counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
2 sitesBangladesh
Study dates
1 Oct 2026to Jul 2027
Phase
Interventional

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Demographics: Female, aged 18 years and above at the time of enrolment.
  • Clinical Threshold: Presenting with moderate to severe symptoms of depression or anxiety. This will be objectively defined and confirmed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9) and/or the Generalised Anxiety Disorder-7 (GAD-7) scale during the formal baseline assessment. Specifically, moderate, moderately severe, and severe depression are defined by PHQ-9 cut-off scores of 10, 15, and 20, respectively. Moderate and severe anxiety are defined by GAD-7 cut-off scores of 10 and 15, respectively.
  • Trial Compliance: Demonstrated willingness to be randomly assigned (1:1 ratio) to either the tele-counselling intervention arm or the in-person active control arm.
  • Informed Consent: Provision of voluntary, written informed consent prior to any baseline data collection or clinical intervention.

Who cannot join

  • Severe Psychiatric Comorbidity: Presence of acute or severe psychiatric disorders that require immediate, specialised psychiatric hospitalisation or intensive management (e.g., active psychosis, severe bipolar affective disorder, or severe substance dependence).
  • Imminent Safety Risk: Demonstration of a high risk of suicide or self-harm, as identified during the initial screening (e.g., via a high score on PHQ-9 Item 9), which requires immediate crisis management rather than standard outpatient counselling. To ensure these vulnerable individuals are not left without support, any woman excluded under this criterion will trigger an immediate emergency pathway: the Field Assistant will immediately escort her to the on-site Study Physician for an urgent clinical evaluation. Following this assessment, the Study Physician will facilitate a direct referral to the hospital's emergency department or psychiatric unit for crisis stabilisation, or to the National Institute of Mental Health (NIMH) for specialised care.
  • Concurrent Treatment: Currently receiving ongoing structured psychological counselling or formal psychological treatment from another provider, to prevent confounding the treatment effects of the trial.
  • Medical or Cognitive Impairment: Presence of severe cognitive impairment, intellectual disability, or acute medical instability that would preclude the participant from comprehending the therapeutic material or safely engaging in weekly counselling sessions.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aniqa Tasnim Hossain, MSc contact

+8801716543128

aniqa.hossain@icddrb.org

Ridwana Maher Manna, MPH contact

+8801764777770

ridwana.manna@icddrb.org

Bangladesh2 sites, 2 recruiting
  • Matlab Dakshin Upazila Health Complex (UHC)

    Chāndpur, Matlab Dakshin

    Dr.Md Golam Kawsar, MBBS, +8801711058157, matlabsouth@uhfpo.dghs.gov.bd

    Kamal Kanti, MSS, +880 1558-917967

    Recruiting
  • Dinajpur District Hospital

    Dinājpur

    Dr. Md. Sirazul Islam, MBBS, +8801701248239, dinajpur@hospi.dghs.gov.bd

    Md Hanif Mia, MSS, +880 1610-552540

    Recruiting

Other trials in Bangladesh

About this study

Official title: Improving Women's Mental Health Through Tele-based Wellbeing Centres in Bangladesh: An Efficacy Trial.

  1. 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.
  2. 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.
  3. Relevance:

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.

Read more

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.

Read the detailed description

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.

Conditions
Depression, Anxiety
Being tested
Tele-counselling, In-person counselling
Keywords
Tele-mental health, Women's mental health, Depression, Anxiety, Tele-counselling, Non-inferiority trial, Bangladesh
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-counsellingBehavioural

    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.

  • In-person counsellingBehavioural

    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.

Study groups in NCT07890896
Study groupRoleWhat they receive
Tele-counselling InterventionExperimentalWomen 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.
Receives: Behavioral: Tele-counselling
In-person ControlActive comparatorWomen will receive face to face counselling from a facility-based psychologist in a private room at the health facility.
Receives: Behavioral: In-person counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 32 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 32 weeks

Secondary outcomes (7)
  1. 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.

    Measured: From enrollment to the end of treatment at 32 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 32 weeks

  3. 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.

    Measured: From enrollment to the end of treatment at 32 weeks

  4. 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.

    Measured: From enrollment to the end of treatment at 32 weeks

  5. 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

    Measured: From enrollment to the end of treatment at 32 weeks

  6. 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.

    Measured: During Enrollment only

  7. 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.

    Measured: At the end of the study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start1 Oct 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A two-arm parallel-group, randomized controlled non-inferiority trial. Participants are randomly assigned in a 1:1 ratio to receive either tele-based counselling or standard in-person counselling. Randomization is executed independently within each of the two selected facilities (within-facility randomization) to control for population-level and environmental confounders.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07890896
Sponsor's protocol ID
PR-26-043
Other IDs
PRAPP-26-103
Status last verified
Oct 2026
First submitted
4 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Shomik MS, Hossain AT, Hossain S, Rahman MH, Manna RM, Islam SMH, Ara T, Al Mamun MA, Islam MS, Jabeen I, Juthi JM, Shahrin F, Shams SA, Afroze F, Usmani NG, Sakil Z, Ahamed B, Khan MA, Rahman SMM, Ahmed HU, Maruf M, Chandra P, Ameen S, Ahmed A, Amin MR, Arifeen SE, Rahman AE. Early feasibility of telemedicine-based mental health wellbeing centers: an implementation study in district and sub-district health facilities in Bangladesh. BMC Health Serv Res. 2026 May 6;26(1):883. doi: 10.1186/s12913-026-14655-3.

    PubMed 42092931
  • Hossain AT, Rahman MH, Manna RM, Akter E, Islam SMH, Hossain MA, Ara T, Usmani NG, Chandra P, Khan MA, Rahman SMM, Ahmed HU, Mozumder MK, Juthi JM, Shahrin F, Shams SA, Afroze F, Banu MJ, Ameen S, Jabeen S, Ahmed A, Amin MR, Arifeen SE, Shomik MS, Rahman AE. Enhancing Access to Mental Health Services for Antepartum and Postpartum Women Through Telemental Health Services at Wellbeing Centers in Selected Health Facilities in Bangladesh: Implementation Research. JMIR Pediatr Parent. 2025 Jan 3;8:e65912. doi: 10.2196/65912.

    PubMed 39753209

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