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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
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.
Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGEnrollment 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.
Time frame: 6 weeks following enrollment
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.
Time frame: 6 weeks following enrollment
mHealth App Usability Questionnaire
Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness
Time frame: 6 weeks following enrollment
Pittsburgh Sleep Quality Index
Validated measure of difficulty falling and staying asleep and subsequent daytime function
Time frame: At enrollment and 6 weeks following enrollment
Structured Clinical Interview for Sleep Disorders - Revised Edition
Assessment for sleep disorders based on the DSM-5
Time frame: At enrollment and 6 weeks following enrollment
Insomnia Severity Index
Global sleep quality; the most common self-reported sleep measure
Time frame: At enrollment and 6 weeks following enrollment
Daily Sleep Diary - Sleep Onset Latency
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Subjective sleep onset latency (time to fall asleep)
Time frame: Through study completion of 6 weeks
Daily Sleep Diary - Wake-time After Sleep
Subjective time awake after sleep onset
Time frame: Through study completion of 6 weeks
Daily Sleep Diary - Total Sleep Time
Subjective total sleep time
Time frame: Through study completion of 6 weeks
Daily Sleep Diary - Sleep Efficiency
Subjective sleep efficiency
Time frame: Through study completion of 6 weeks