Overview
- 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.
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.
Eligibility
Inclusion Criteria -
- 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.
Exclusion Criteria -
- 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.
