Healthy Minds Program for Veterans With Opioid Use Disorder on Buprenorphine Maintenance Treatment: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
- 主要终点
- Retention in treatment
研究概览
简要总结
The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment.
Participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.
详细描述
This is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the Healthy Minds Program for Veterans with opioid use disorder on buprenorphine maintenance treatment.
Following the Screening Visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. The first session will be an introductory session introducing the basics of the program. After the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. Participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. The intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. Weekly sessions will be held in person and will be facilitated by an MD, PhD Psychiatrist and Neuroscientist with 8 years of mindfulness practice together with a certified Peer Support Specialist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals at least 18 years of age
- •English-speaking
- •Ability to understand and willingness to sign a written informed consent document
- •Have access to a smartphone, tablet, or computer with internet connection to access recordings for home practice
- •Ability and willingness to attend all 6 session of the study, and to complete all assessment questionnaires
- •Verified Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria
- •On buprenorphine maintenance treatment for Opioid use disorder (OUD) for a minimum of 3 months
排除标准
- •Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- •Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- •Previous use of Healthy Minds Program app
- •Current suicidal intent and/or high self-injury risk, as determined from the interview
- •Current psychopathology that interferes with study participation as assessed by interview
结局指标
主要结局
Retention in treatment
时间窗: Through study completion, up to 4 months
Number of participants who complete all 6 sessions, as measured through actual attendance.
Change in predictors of relapse and recovery
时间窗: Baseline, 3 weeks, 6 weeks
The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use (scores 0-24, higher scores meaning more risk), protective factors that support sobriety (scores 0-24, higher scores meaning more protection), and drug and alcohol use (scores 0-12, higher scores meaning more use). The BAM produces composite scores for the three aforementioned domains.
次要结局
- Change in well-being(Baseline, 3 weeks, 6 weeks)
- Change in psychological distress - perceived stress(Baseline, 3 weeks, 6 weeks)
- Change in psychological distress - anxiety and depression(Baseline, 3 weeks, 6 weeks)
- Change in PTSD symptoms(Baseline, 3 weeks, 6 weeks)