Mindfulness-Based Recovery in Veterans With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 4
- 主要终点
- Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date
研究概览
简要总结
This study will provide important information concerning the used of mindfulness-based relapse prevention (MBRP) as a continuing care strategy for Veterans who have completed primary treatment for a SUD. Most research is focused on the acute care of SUDs, but the risk of relapse to substance use is highest during the period immediately following treatment and attention to continuing care is critical. If this trial demonstrates that MBRP promotes sustained abstinence and improved functional outcomes, this will provide a valuable treatment to facilitate rehabilitation and recovery for Veterans with SUDs.
详细描述
Rates of substance use disorders (SUDS) are high among military personnel and Veterans. While much research is focused on the acute care of SUDs, the risk of relapse to substance use following treatment is high and attention to continuing care is critical. New continuing care strategies targeting life-style change and improved coping mechanisms are important in facilitating maintenance of abstinence, promoting rehabilitation and functional recovery for Veterans with SUDs. Mindfulness-based relapse prevention (MBRP), a manualized treatment integrating cognitive-behavioral relapse prevention therapy with mindfulness practices, has shown promise in continuing care for SUDs. The proposed project will compare MBRP to a 12-Step Facilitation treatment as a continuing care strategy following primary treatment for SUDs. Participants will be randomized to participate in 8-weeks of weekly 90-minute, group-based MBRP or 12-Step Facilitation followed by a 10-month follow-up period with regular assessments of substance use, mood/anxiety symptoms, quality of life and functional outcomes. Two VAMC sites (Charleston and Tuscaloosa) with a history of successful collaboration will work together to recruit an adequate sample size to address the primary study questions within a 4-year period and to ensure generalizability of the results. If this trial demonstrates that MBRP promotes sustained abstinence and improved functional outcomes, this will provide a valuable treatment to facilitate rehabilitation and recovery for Veterans with SUDs.
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
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women military Veterans who have completed the Charleston or Tuscaloosa Veterans Administration Medical Center (VAMC) intensive outpatient substance abuse treatment program, a residential treatment program, or an intensive outpatient program similar to the Charleston or Tuscaloosa VAMC program.
- •Able to comprehend English.
- •Meets DSM-V criteria for a current substance use disorder and have used substances in the 30 days prior to treatment entry. Participants on medications targeting their substance use must be stabilized on medications for at least 2 weeks before therapy initiation.
- •May meet criteria for a mood, anxiety or other psychiatric disorder. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation.
- •Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- •Willing to commit to 8 group therapy sessions, baseline, weekly and follow-up assessments for 10-months after the end of treatment (12-month total).
排除标准
- •Active suicidal or homicidal ideation with a plan as this is likely to require hospitalization or other interventions that could interfere with study participation.
- •Unstable psychiatric condition likely to require hospitalization or other interventions that would interfere with study participation.
- •Unstable medical condition or one that may require hospitalization during the course of the study.
- •Meets criteria for nicotine dependence only
- •Women who are pregnant
结局指标
主要结局
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date
时间窗: Study Treatment Duration up to 8 Weeks
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use in treatment up to 8 weeks will be assessed.
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date
时间窗: Study Treatment Duration through 10 Months Follow up
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports (Carey, 1997). Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use during treatment through10 months will be assessed.
Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data
时间窗: Study Treatment Duration through 10 Months
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Participants that failed to return for any treatment or follow up visits are considered censored at study day 1.
次要结局
- Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.(Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months)
- Mindfulness Acceptance and Awareness Scale (MAAS)(Baseline, End of treatment, 3 Months, 6 Months, 10 Months)
- Addiction Severity Index, Lite(8 Weeks, 3 Months, 6 Months, 10 Months)
- Days Engaging in Structured/Productive Work Activities (PWAC)(Weekly, Week 8, 3 Months, 6 Months, 10 Months)
- Treatment Engagement: Treatment Attendance Calendar (TAC)(Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months)
- Urine Drug Screen - End of Study(End of Study (up to 1 year))
- Beck Depression Inventory 2(Baseline, End of Treatment, 3 Months, 6 Months, 10 Months)
- Beck Anxiety Inventory(Baseline, End of Treatment, 3 Months, 6 Months, 10 Months)
- Urine Drug Screen(Weekly, Week 8, 3 Months, 6 Months, 10 Months)
- EtG(Week 8, 3 Months, 6 Months, 10 Months)