Opioid Use Disorder, Poor Quality Sleep
Conditions
Brief 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.
Detailed 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 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.
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.
Sponsors
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * Current severe SUD other than OUD (i.e., \> 5 criteria met for any other SUD type per DSM-5) * Peripartum women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages | 6 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 - Engagement | 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. |
| mHealth App Usability Questionnaire | 6 weeks following enrollment | Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | At enrollment and 6 weeks following enrollment | Validated measure of difficulty falling and staying asleep and subsequent daytime function |
| Structured Clinical Interview for Sleep Disorders - Revised Edition | At enrollment and 6 weeks following enrollment | Assessment for sleep disorders based on the DSM-5 |
| Insomnia Severity Index | At enrollment and 6 weeks following enrollment | Global sleep quality; the most common self-reported sleep measure |
| Daily Sleep Diary - Sleep Onset Latency | Through study completion of 6 weeks | Subjective sleep onset latency (time to fall asleep) |
| Daily Sleep Diary - Wake-time After Sleep | Through study completion of 6 weeks | Subjective time awake after sleep onset |
| Daily Sleep Diary - Total Sleep Time | Through study completion of 6 weeks | Subjective total sleep time |
| Daily Sleep Diary - Sleep Efficiency | Through study completion of 6 weeks | Subjective sleep efficiency |
Countries
United States
Contacts
CONTACTAllison K Willkerson, Ph.D.
CONTACTJacelyn Lane
PRINCIPAL_INVESTIGATORAllison K Wilkerson, Ph.D.
Medical University of South Carolina
Outcome results
None listed