Friendship Bench & Lighthouse
Haiphong, Hai Phong, 100000, Vietnam
Location status: Recruiting
Location contact
Trang Thu Nguyen, PhD
CONTACT
Trang Thu Nguyen, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06789523
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Haiphong, Hai Phong, 100000, Vietnam
Location status: Recruiting
Trang Thu Nguyen, PhD
CONTACT
Trang Thu Nguyen, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Hanoi Medical University
Other
Acronym: FB-WWUM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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