Tele-based wellbeing centres for women's mental health in Bangladesh

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized non-inferiority trial compares tele counselling delivered through Wellbeing Centres to standard face-to-face counselling for women with moderate to severe symptoms of depression or anxiety in Bangladesh. It enrolls 1,200 adult women from two facilities and randomizes them 1:1 to tele-counselling or in-person counselling. Both arms use the same counselling manual, session count, duration, and supervision, with outcomes measured at 2, 4, and 6 months using symptom scales and quality of life. A qualitative component explores experiences, sociocultural factors, and technology use. The study aims to inform policy decisions and scale-up of accessible mental health services for women.

Why it matters

Who can join: the full rules

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.

Where it's running

• Matlab Dakshin Upazila Health Complex (UHC)
  Chāndpur, Matlab Dakshin, Bangladesh Recruiting
• Dinajpur District Hospital
  Dinājpur, Bangladesh Recruiting

Study contacts

• Principal investigator: Aniqa Tasnim Hossain, MSc — Associate Scientist, icddr,b
• Study coordinator: Aniqa Tasnim Hossain, MSc
• Email: aniqa.hossain@icddrb.org
• Phone: +8801716543128

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

  This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07852728

• Focused ultrasound for mood and anxiety disorders

  This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.

  Recruiting Attune Neurosciences Inc · San Francisco, California and 1 other locations · NCT07851038

• An Ultra-Brief ICBT Intervention with Personal Feedback for Depression and Anxiety

  This trial tests whether adding personalized feedback about a person’s recent healthy actions to the Things You Do ultra-brief online CBT program helps adults with depression and anxiety do more healthy activities and feel better.

  Recruiting University of Regina · Regina, Saskatchewan · NCT07806864

• Virtual nature vs guided imagery for anxiety and well-being in hospitalized older adults

  In this study, hospitalized adults 65 and older try two ways to bring nature to them: watching 360-degree nature videos on a VR headset or listening to a guided imagery audio to imagine the same scenes, to see which helps mood and anxiety during a two-week period.

  Recruiting at 2 sites Semmelweis University · Budapest and 1 other locations · NCT07765355

• Culturally tailored nurse-led COPE program for caregivers of children with autism

  This study tests a culturally adapted COPE program led by nurses to help primary caregivers of children with autism feel less distressed, alongside standard care.

  Recruiting Khyber Medical University Peshawar · Faisalābad, Punjab Province · NCT07722949

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.