A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders- R61
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Number of Days Adherence to Medication Assisted Treatment
研究概览
简要总结
The proposed research effort will:
The purpose of this study is as follows:
- Test the feasibility and acceptability of a twelve- week mindfulness based relapse prevention protocol in combination with peer mentoring in individuals with opioid use disorder who are on medication assisted treatment.
- Determine whether participation in a combination of mindfulness based relapse prevention and peer mentoring in comparison with an attentional control group: a) improves adherence to MAT b) decreases relapse and cravings c) improves psychosocial outcomes such as depression, anxiety, stress and social support
详细描述
Although medication assisted therapy (MAT) for opioid use disorders (OUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MAT regimens remains a challenge. The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition to professional substance abuse therapists (the Minds and Mentors program [MiMP]) in improving adherence to MAT for OUD and reducing relapse rates in a sample of individuals with OUD who are also on MAT versus a twelve-step facilitation (TSF) program. The MiMP is a twelve-week intervention that uses group therapy and meets once a week for about two hours for eight weeks with a professional substance abuse therapist; after the completion of eight therapist led sessions, participants will attend four weeks of group therapy sessions conducted by a peer mentor. The peer mentor will also attend the initial eight sessions with the therapist to establish rapport with participants. The control group will attend twelve weeks of a standard twelve-step facilitation program. This study will utilize an individually randomized group treatment design with ten participants in both the intervention and control groups. Data collection will occur at baseline, end of treatment, and at 3, 6, and 12- month follow-up.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 19 years old.
- •Opioid Use disorder diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria in the past 30 days
- •Currently receiving MAT for OUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
- •Are within maintenance phase of MAT (not actively detoxing)
- •May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
- •Capable of reading and understanding English
- •Able to provide written informed consent (i.e. no surrogate)
- •Willing to commit to 8 group therapy sessions, baseline, and follow-up assessments for 12-months after the end of treatment (14- month total)
排除标准
- •Significant cognitive impairment
- •Women who are pregnant
- •Actively suicidal or homicidal
- •Active psychosis and/ or
- •Unstable medical conditions that contraindicate proposed treatment
- •Subject exit criteria:
- •Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
- •Newly developed active suicidal or homicidal ideation
- •Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
- •Inability to return for therapy sessions due to incarceration or hospitalization lasting longer than four weeks.
结局指标
主要结局
Number of Days Adherence to Medication Assisted Treatment
时间窗: Last 4 weeks of the intervention period
The primary outcome variable is adherence to medication-assisted therapy (MAT), quantified as the number of days MAT was received as indicated during the last 4 weeks of the intervention period. We expect that this can be treated as a continuous variable in regression models.
次要结局
- Social Support as Measured by the Community Assessment Inventory(6 months)
- Stress as Measured by the Perceived Stress Scale(6 months)
- Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate(12 months)
- Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale(3 months - at the end of the 12 week intervention)
- Satisfaction With the Intervention Program(3 months - at the end of the 12 week intervention)
- Acceptability of the Intervention Programs(3 months)
- Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report(3 months)
- Opioid Cravings as Measured by the Opioid Craving Scale(6 months)
- Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen(Last four weeks of the 12-week intervention)
- Depression as Measured by the Patient Health Questionnaire(6 months)
- Anxiety as Measured by the Generalized Anxiety Disorder Scale(6 months)
- Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate(12 months)
- Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate(12 months)