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.
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)
Current psychotic symptoms
Current active suicidal ideation
Severe visual impairment
Current use of benzodiazepines
Parallel
mHealth application and sleep health education
DeviceStudy 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
Simplified mHealth application and sleep health education
DeviceStudy 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.
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
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 - Engagement
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 Questionnaire
Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness
Pittsburgh Sleep Quality Index
Validated measure of difficulty falling and staying asleep and subsequent daytime function
Structured Clinical Interview for Sleep Disorders - Revised Edition
Assessment for sleep disorders based on the DSM-5
Insomnia Severity Index
Global sleep quality; the most common self-reported sleep measure
Daily Sleep Diary - Sleep Onset Latency
Subjective sleep onset latency (time to fall asleep)
MOUD and drug use
Self-reported checklist
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Medical University of South Carolina
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
