Friendship Bench for Women Who Use Methamphetamine in Vietnam (FB-WWUM)

August 6, 2025 updated by: Hanoi Medical University
The high comorbidity of mental health issues and meth use in women worsens both their mental health and meth use outcomes. The study team proposes to evaluate the potential of Friendship Bench to be used as a low-threshold, task-shifting mental health intervention among women who use methamphetamine in Vietnam - a lower-middle-income country. The study will provide preliminary data for a R01 trial testing the effectiveness Friendship Bench to improve mental health and methamphetamine use outcomes among women who use methamphetamine in Vietnam.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this research proposal are to: (1) assess the mental health needs of WWUM in Haiphong, (2) adapt Friendship Bench to the specific needs of Vietnamese WWUM and (3) assess the feasibility, fidelity, and acceptability of the adapted Friendship Bench for common mental disorders among WWUM and preliminary indicators of its impact in improving their mental health and methamphetamine use in a two-arm randomized trial, comparing Friendship Bench with usual psychiatric care.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Haiphong, Vietnam, 100000
        • Recruiting
        • Friendship Bench & Lighthouse
        • Contact:
        • Principal Investigator:
          • Trang Thu Nguyen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult women (>=18 years old)
  • Moderate or greater risk for meth use (ASSIST ≥ 4)
  • Moderate or greater CMD symptom severity (Depression ≥ 10, Anxiety ≥ 8, and/or Stress ≥ 15 on DASS-21)

Exclusion Criteria:

  • Severe psychotic disorders or other interfering problems that require specialty care;
  • Inability to understand study procedures by the research team's judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Friendship Bench
Participants randomized to the intervention condition will receive the adapted Friendship Bench intervention.
Behavioral: Friendship Bench

The Friendship Bench model comprises 6 weekly, individual sessions with trained peer workers in addition to the usual care. Peer workers will help participants identify problems, outline potential solutions, and implement selected solutions.

The adaptation of Friendship Bench for Vietnamese methadone patients made revisions, such as removing the 'Belief in supernatural powers' section, replacing the Shona Symptom Questionnaire with DASS-21, and adding meth use. But this adaptation removed women-focused content on pregnancy and postpartum depression that we plan to include.
Active Comparator: Usual psychiatric care
Participants in the control group will receive usual care for their common mental disorders.
Behavioral: Usual psychiatric care
Usual care includes monthly check-ups by peer workers, referral to hospital-based psychiatric services or other available mental health services if needed. This usual care might surpass standard psychiatric care in other provinces given that peer workers in Haiphong have been well trained on case management skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
Time Frame: From enrollment to the end of intervention at 6 weeks
The ability to enroll WWUM is assessed through the recruitment rate (number of WWUM approached to accrue the final sample) and reasons for non-participation.
From enrollment to the end of intervention at 6 weeks
Feasibility: the ability to retain WWUM with common mental disorders in the pilot
Time Frame: From enrollment to the end of intervention at 6 weeks
Based on data from previous studies in Vietnam, the study team defines feasible retention as 80% retention at 6-weeks.
From enrollment to the end of intervention at 6 weeks
Feasibility: adequate completion of Friendship Bench sessions
Time Frame: From enrollment to the end of intervention at 6 weeks
As peer outreach workers will conduct home visits or visits to workplace, the study team considers 70% participants attending all 6 individual sessions to be feasible. The reasons for session non-attendance, and counselor time per session and per patient including preparation, documentation, and supervision will also be assessed to explain the Friendship Bench completion rate.
From enrollment to the end of intervention at 6 weeks
Acceptability
Time Frame: At Week 6
Acceptability is defined as the perception among implementation stakeholders that the intervention is agreeable or satisfactory. The study team will assess acceptability through the 6-week follow-up interview with all participants (n=100) and peer workers (n=10). Acceptability will also be assessed qualitatively using the post-intervention in-depth interviews with peer workers (n=10), participants (n=20) and brief exit interviews with supervisors (n=2). The interviews will assess how easy the intervention is to participate and to deliver, the perceived usefulness of the intervention and suggestions for improvement. Intervention acceptability is defined as 80% participants rating the intervention as acceptable and by a common theme of positive perceptions of Friendship Bench in qualitative data.
At Week 6
Fidelity
Time Frame: From enrollment to the end of intervention at 6 weeks
Fidelity is defined as delivery of the intervention as intended. Master trainers will use a checklist to assess fidelity to session content either during direct monitoring or using audio recording of 1 randomly chosen session per patient or up to 8 sessions per counselor. Covering at least 75% of checklist items during each session is considered fidelity to the intervention protocol.
From enrollment to the end of intervention at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental health: changes in CMD symptom response
Time Frame: From enrollment to the end of intervention at 6 weeks
The mental health outcome is defined to be common mental disorders symptom response and measured as a composite score. Common mental disorders symptom response is based on common mental disorders symptom improvement. Common mental disorders symptom improvement is defined as the percent improvement in each depression, anxiety and stress subscale of the 21-item Depression, Anxiety and Stress Scale (DASS-21) from baseline, averaged across only those subscales that were elevated at baseline. Each subscale ranges from 0 to 42, with higher scores indicating worse outcomes.
From enrollment to the end of intervention at 6 weeks
Meth use: self-reported changes in meth use behaviors
Time Frame: From enrollment to the end of intervention at 6 weeks
Meth use outcomes include changes in the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) score for meth and the amphetamine use behaviors scale between baseline and follow-up visits. The ASSIST score ranges from 0 to 39 for each drug assessed, higher scores indicating greater risk.
From enrollment to the end of intervention at 6 weeks
Meth use: changes in urinalysis
Time Frame: From enrollment to the end of intervention at 6 weeks
Changes in the number of participants with positive urinalysis between baseline and follow-up visits.
From enrollment to the end of intervention at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Collaborators

National Institute on Drug Abuse (NIDA)
University of North Carolina, Chapel Hill
Fogarty International Center of the National Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K43TW012620-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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