Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
研究概览
简要总结
This study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.
详细描述
This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.
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
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
- •No experience of withdrawal symptoms in past 2 weeks
- •Being stabilized on buprenorphine
- •Initiated buprenorphine in past 3 months
- •Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
- •Currently experiencing clinically significant sleep disturbance (PSQI > 5)
- •Able to read and understand English
- •Owns an Android or iOS smartphone
- •At least 18 years of age
排除标准
- •Current psychotic symptoms
- •Current active suicidal ideation
- •Severe visual impairment
- •Current use of benzodiazepines
- •Current severe SUD other than OUD (i.e., > 5 criteria met for any other SUD type per DSM-5)
- •Peripartum women
研究组 & 干预措施
mHealth application
Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.
干预措施: mHealth application and sleep health education (Device)
Control Group
Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity.
干预措施: Simplified mHealth application and sleep health education (Device)
结局指标
主要结局
Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
时间窗: 6 weeks following enrollment
Completing at least one module per week, submitting a minimum of four sleep diaries per week, and implementing stimulus control and sleep restriction on at least 90% of nights.
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
时间窗: 6 weeks following enrollment
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period.
mHealth App Usability Questionnaire
时间窗: 6 weeks following enrollment
Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness
次要结局
- Daily Sleep Diary - Total Sleep Time(Through study completion of 6 weeks)
- Insomnia Severity Index(At enrollment and 6 weeks following enrollment)
- Structured Clinical Interview for Sleep Disorders - Revised Edition(At enrollment and 6 weeks following enrollment)
- Daily Sleep Diary - Sleep Onset Latency(Through study completion of 6 weeks)
- Daily Sleep Diary - Wake-time After Sleep(Through study completion of 6 weeks)
- Daily Sleep Diary - Sleep Efficiency(Through study completion of 6 weeks)
- Pittsburgh Sleep Quality Index(At enrollment and 6 weeks following enrollment)
研究者
Allison Wilkerson
Associate Professor
Medical University of South Carolina