Friendship Bench for Women Who Use Methamphetamine in Vietnam

Not Applicable

Not yet recruiting

• Conditions: Methamphetamine Use; Common Mental Disorders (CMD)

• Registration Number: NCT06789523
• Lead Sponsor: Hanoi Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-09-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot	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.
Feasibility: the ability to retain WWUM with common mental disorders in the pilot	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.
Feasibility: adequate completion of Friendship Bench sessions	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.
Acceptability	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.
Fidelity	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.

Secondary Outcome Measures

Name	Time	Method
Mental health: changes in CMD symptom response	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.
Meth use: self-reported changes in meth use behaviors	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.
Meth use: changes in urinalysis	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.

Trial Locations

Locations (1)

Center for Training and Research on Substance Use & HIV; 🇻🇳 Hanoi, Vietnam