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RECRUITING

NCT07890896

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

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

View on ClinicalTrials.gov

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. 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. 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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-10-01

Completion Date

2027-07

Last Updated

2026-10-22

Healthy Volunteers

Conditions

Depression Anxiety

Interventions

BEHAVIORAL

Tele-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.

BEHAVIORAL

In-person counselling

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.

Inclusion Criteria - 1. Demographics: Female, aged 18 years and above at the time of enrolment. 2. 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. 3. 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. 4. Informed Consent: Provision of voluntary, written informed consent prior to any baseline data collection or clinical intervention. Exclusion Criteria - 1. 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). 2. 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. 3. Concurrent Treatment: Currently receiving ongoing structured psychological counselling or formal psychological treatment from another provider, to prevent confounding the treatment effects of the trial. 4. 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.

Locations (2)

Matlab Dakshin Upazila Health Complex (UHC)

Chāndpur, Matlab Dakshin, Bangladesh

Dinajpur District Hospital

Dinājpur, Bangladesh