Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of Access
研究概览
简要总结
The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are:
- Will people with opioid use disorder and childhood trauma use mobile mindfulness training?
- Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress?
Participants will:
Be given access to mobile mindfulness training and encouragement to use it daily for 30 days.
Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)
- •Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky
- •On a stable dose of buprenorphine, buprenorphine/naloxone, or naloxone (i.e., at least 30 days post-induction and on a stable dose for 30 days)
- •Able to read and understand English
- •Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and/or Childhood Trauma Questionnaire.
排除标准
- •Currently taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication
- •Uncontrolled acute or chronic health conditions (e.g., active infections, autoimmune conditions, cancer undergoing active treatment)
- •Current or expected pregnancy
- •Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)
- •Primary psychotic illness
- •Diagnosis of a disorder known to interfere with neurocognitive function (e.g., estimated full scale IQ below 70 or diagnosis of dementia)
研究组 & 干预措施
Mobile Mindfulness First
This is a crossover trial. Participants in this arm will have 30 days of mobile mindfulness training first then a 14 day washout and then 30 days of treatment as ususal.
干预措施: Mobile Mindfulness Training (Behavioral)
Treatment As Usual First
This is a crossover trial. Participants in this study arm will have 30 days of treatment as usual then a 14 day washout and then 30 days of mobile mindfulness training
干预措施: Mobile Mindfulness Training (Behavioral)
结局指标
主要结局
Feasibility of Access
时间窗: 75 days after enrollment
Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.
Proportion of Acceptability
时间窗: 75 days after enrollment
Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.
次要结局
- Change in Trauma Symptoms(180 days after enrollment)
- Change in Mindfulness(180 days after enrollment)
研究者
Amy Meadows
Associate Professor
University of Kentucky