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Outcome Measures

Primary Outcomes (2)

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.
From enrollment to the end of treatment at 32 weeks
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.
From enrollment to the end of treatment at 32 weeks

Secondary Outcomes (7)

Health-Related Quality of Life
From enrollment to the end of treatment at 32 weeks
Common Presentation of Conditions
From enrollment to the end of treatment at 32 weeks
Wellbeing Index
From enrollment to the end of treatment at 32 weeks
Psychological Distress
From enrollment to the end of treatment at 32 weeks
Gender-Based Violence (GBV) Exposure (Baseline T0 & Follow-up Period T1, T2, T3)
From enrollment to the end of treatment at 32 weeks
+2 more secondary outcomes

Study Arms (2)

Tele-counselling Intervention

EXPERIMENTAL

Women 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.

Behavioral: Tele-counselling

In-person Control

ACTIVE COMPARATOR

Women will receive face to face counselling from a facility-based psychologist in a private room at the health facility.

Behavioral: In-person counselling

Interventions

Tele-counsellingBehavioral

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.

Tele-counselling Intervention

In-person counsellingBehavioral

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.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Related Publications (2)

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.

PMID: 42092931BACKGROUND

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.

PMID: 39753209

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Due to the physical nature of the interventions, participants and treating psychologists cannot be blinded to the assigned delivery modality. However, the independent Field Assistants who conduct the longitudinal follow-up psychometric assessments will remain strictly blinded to the participants' group allocation. Participants will be explicitly instructed not to disclose their assigned treatment modality during these evaluations.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (2)

Tele-counselling Intervention

In-person Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Available IPD Datasets

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (2)

Tele-counselling Intervention

In-person Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Available IPD Datasets

Source record

Documents

Locations