Adapting and Pilot Testing Mindfulness-Based Relapse Prevention for Substance Use Peer Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in biologically verified substance use at 1, 3, and 6 months as measured by Saliva Drug Assays
研究概览
简要总结
Adapt and test the effectiveness of MBRP for substance use peer workers compared to a standard of care (referral to 12-step) control condition on substance use, relapse risk, and burnout among peers in a pilot hybrid type 1 trial.
The goal of this clinical trial is to learn if Mindfulness-Based Relapse Prevention can reduce substance use, relapse risk, and burnout among substance use peer workers. The objectives are to:
- Identify the causes, consequences, and risk and protective factors for relapse among peer workers;
- Identify peers' preferences related to MBRP content, structure, and delivery;
- Adapt the MBRP intervention for peer workers; and
- Assess the preliminary effectiveness and implementation outcomes of the adapted MBRP intervention.
Researchers will compare MBRP to referral to 12-step (standard of care) to see if MRBP works to reduce substance use, relapse risk, and burnout.
Participants will asked to:
- Participate in MBRP (8 weekly 2-hour virtual sessions)
- Complete 4 surveys assessing well-being outcomes
- Participate in 1 virtual interview about your experience
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are > 18 years old
- •Fluent in English
- •Be currently employed in a substance use peer support role
- •At-risk for SUD relapse as measured by a craving score of >15 on the adapted Penn Alcohol Craving Scale
排除标准
- •Have a cognitive impairment that jeopardizes informed consent
- •Actively suicidal or psychotic
研究组 & 干预措施
Intervention Arm
MBRP for Peer Workers
干预措施: Mindfulness Based Relapse Prevention (Behavioral)
Control Arm
Standard of Care
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Change from baseline in biologically verified substance use at 1, 3, and 6 months as measured by Saliva Drug Assays
时间窗: From enrollment to 6 months
Saliva drug assays detecting the presence or absence of commonly used substances. Results are reported as positive or negative for each substance tested, with negative results indicating a better outcome.
Change from baseline in self-reported substance use days at 1, 3, and 6 months as measured by the Timeline Follow-Back (TLFB)
时间窗: From enrollment to 6 months
A calendar-based interview assessing daily substance use over a specified recall period. Outcomes are reported as the number of days of substance use during the assessment period, with fewer days indicating a better outcome.
Change from baseline in relapse warning Signs at 1, 3, and 6 months as measured by the Advance Warning of Relapse (AWARE) Questionnaire
时间窗: From enrollment to 6 months
A 28-item; 7-point Likert-type scale assessing warning signs associated with relapse risk. Total scores range from 28 to 196, with higher scores indicating greater relapse risk (worse outcome).
Change from baseline in professional quality of life at 1, 3, and 6 months as measured by the Professional Quality of Life Scale (ProQOL)
时间窗: From enrollment to 6 months
A 30-item; 5-point Likert-type scale assessing professional quality of life across three 10-item subscales: Compassion Satisfaction, Burnout, and Secondary Traumatic Stress. Each subscale score ranges from 10 to 50. Higher Compassion Satisfaction scores indicate a better outcome, whereas higher Burnout and Secondary Traumatic Stress scores indicate worse outcomes.
Post-intervention perceived feasibility of the intervention as measured by the Feasibility of Intervention Measure (FIM)
时间窗: Immediately after the final intervention session
A 4-item; 5-point Likert-type scale assessing the perceived feasibility of an intervention. Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility (better outcome).
Post-intervention perceived acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
时间窗: Immediately after the final intervention session
A 4-item; 5-point Likert-type scale assessing the perceived acceptability of an intervention. Total scores range from 4 to 20, with higher scores indicating greater perceived acceptability (better outcome).
次要结局
- Change from baseline in the coping score assessed by the Brief-COPE measure at 6 months(From enrollment to 6 months)
- Change from baseline in total score of emotion regulation assessed by the Difficulty in Emotion Regulation Scale (DERS) measure at 6 months(From enrollment to 6 months)
- Change from baseline in total score of perceived stress assessed by the Perceived Stress Scale (PSS-10) measure at 6 months(From enrollment to 6 months)
- Change from baseline in total score of trait mindfulness assessed by the Five Factor Mindfulness Questionnaire (FFMQ-15) measure at 6 months(From enrollment to 6 months)
- Change from baseline in total score of acceptance assessed by the Acceptance and Action Questionnaire-II (AAQ-II) measure at 6 months(From enrollment to 6 months)
研究者
Katie McCormick
Research Assistant Professor
University of Texas at Austin