Loading
Life sciences · Interventional Study
ClinicalTrials.gov · October 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07890896). This is a study registration, not published results. Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1200 participants (ESTIMATED). Conditions: Depression, Anxiety. Interventions: BEHAVIORAL: Tele-counselling; BEHAVIORAL: In-person counselling. Primary outcome measures: Depressive Symptom , From enrollment to the end of treatment at 32 weeks; Anxiety Symptom , From enrollment to the end of treatment at 32 weeks. Brief 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.