Friendship Bench for Women Who Use Methamphetamine in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Severe psychotic disorders or other interfering problems that require specialty care;
- •Inability to understand study procedures by the research team's judgment.
研究组 & 干预措施
Friendship Bench
Participants randomized to the intervention condition will receive the adapted Friendship Bench intervention.
干预措施: Friendship Bench (Behavioral)
Usual psychiatric care
Participants in the control group will receive usual care for their common mental disorders.
干预措施: Usual psychiatric care (Behavioral)
结局指标
主要结局
Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Mental health: changes in CMD symptom response(From enrollment to the end of intervention at 6 weeks)
- Meth use: self-reported changes in meth use behaviors(From enrollment to the end of intervention at 6 weeks)
- Meth use: changes in urinalysis(From enrollment to the end of intervention at 6 weeks)