mHealth App for Sleep in Opioid Use Disorder
This study is testing an mHealth (mobile health) app designed to improve sleep for people with Opioid Use Disorder (OUD) who are also receiving medication-assisted treatment (MAT) with buprenorphine. The app uses principles from cognitive behavioral therapy for insomnia (CBT-I) and other sleep interventions. You might be able to join if you are 18 or older, have been stable on buprenorphine for at least two weeks, and are experiencing significant sleep problems. The study aims to see if the app is practical and acceptable to participants, and if people stick with the program. We don't know the current recruitment status, but 40 people are planned to enroll.
- Study design
- This is a pilot randomized controlled trial with 40 participants. Participants will be randomly assigned to one of two groups: a full mHealth app or a simplified mHealth app with sleep hygiene instructions.
- What's involved
- You would download an mHealth app to your smartphone and complete the intervention within 6 weeks. You would also complete daily electronic sleep diaries for 6 weeks and weekly short assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed at 6 weeks following enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Allison K Wilkerson, Ph.D. · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages6 weeks following enrollment
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period.
- Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement6 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.
- mHealth App Usability Questionnaire6 weeks following enrollment
Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness