Friendship Bench for Women Who Use Methamphetamine in Vietnam
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHanoi Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Severe psychotic disorders or other interfering problems that require specialty care;
Inability to understand study procedures by the research team's judgment.
Trial design
Design model
Parallel
Treatments tested in this trial
Friendship Bench
BehavioralThe 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.
Usual psychiatric care
BehavioralUsual 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Friendship BenchExperimental treatment 1 intervention
Group B: Usual psychiatric careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
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.
Time frame
From enrollment to the end of intervention at 6 weeks2
Feasibility: the ability to retain WWUM with common mental disorders in the pilot
Based on data from previous studies in Vietnam, the study team defines feasible retention as 80% retention at 6-weeks.
Time frame
From enrollment to the end of intervention at 6 weeks3
Feasibility: adequate completion of Friendship Bench sessions
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.
Time frame
From enrollment to the end of intervention at 6 weeks4
Acceptability
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.
Time frame
At Week 6Secondary outcomes
1
Mental health: changes in CMD symptom response
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.
Time frame
From enrollment to the end of intervention at 6 weeks2
Meth use: self-reported changes in meth use behaviors
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.
Time frame
From enrollment to the end of intervention at 6 weeks3
Meth use: changes in urinalysis
Changes in the number of participants with positive urinalysis between baseline and follow-up visits.
Time frame
From enrollment to the end of intervention at 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanoi Medical University
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
University of North Carolina, Chapel Hill
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov