Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Adherence to the digital treatment
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.
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
- Double (Investigator, Outcomes Assessor)
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
- •18 years of age or older
- •Fluent in English and have a 6th grade or higher reading level
- •Have completed 1 month or more of SUD treatment
- •Report use of their primary substance of choice in past 6 months
- •Are not currently enrolled in residential/inpatient treatment
- •Are willing to be randomized
- •Are willing and able to participate for the entire study period
- •Are willing to provide locator information for follow-up
- •Own a working, WIFI-enabled smartphone
排除标准
- •Current psychotic disorder
- •High suicide risk characterized by suicidal ideation with intent
- •Homicidal ideation posing imminent danger to others
- •Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period
- •Participation in the Phase 1 User Testing study
研究组 & 干预措施
TAU Plus Digital Mindfulness-Based Treatment
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
干预措施: Treatment-as-Usual (TAU) (Behavioral)
TAU Plus Digital Mindfulness-Based Treatment
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
干预措施: Digital Mindfulness Treatment (Behavioral)
Treatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy
干预措施: Treatment-as-Usual (TAU) (Behavioral)
结局指标
主要结局
Adherence to the digital treatment
时间窗: 8-week treatment period that begins on the day participants are randomized
Percent of randomized participants completing 50% or more of the digital treatment modules
Completion rates for the follow-up assessment visit
时间窗: 2-month post-treatment follow-up (approximately 16 weeks post-randomization)
Percent of randomized participants completing follow-up assessment visit
Completion rates for ecological momentary assessment at post-treatment
时间窗: 2-week period occurring approximately during weeks 10 and 11 post-randomization
Percent of randomized participants completing 50% or more of EMA surveys post-treatment
Completion rates for the post-treatment assessment visit
时间窗: Approximately 9 weeks after randomization
Percent of randomized participants completing post-treatment assessment visit
Completion rates for ecological momentary assessment at baseline
时间窗: 2-week period at baseline prior to randomization
Percent of randomized participants completing 50% or more of EMA surveys at baseline
Dimensions of treatment acceptability
时间窗: Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization
Single-items measuring ratings of acceptability dimensions for the digital treatment, including willingness to engage, usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability.
次要结局
未报告次要终点
研究者
Corey Roos
Assistant Professor of Psychiatry
Yale University