Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
Medical University of South Carolina
Summary
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.
Description
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 w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * No experience of withdrawal symptoms in past 2 weeks * Being stabilized on buprenorphine 1. Initiated buprenorphine in past 3 months 2. 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 Exclusion Criteria: * Current psychotic symptoms * Current active suicidal ideation * Severe visual impairment * Current use of benzodiazepines * Cur…
Interventions
- DevicemHealth application and sleep health education
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to 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
- DeviceSimplified mHealth application and sleep health education
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to 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.
Location
- Medical University of South CarolinaCharleston, South Carolina