Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder

Conditions
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Opioid Use Disorder, Poor Quality Sleep

Intervention / Treatment
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* Device: mHealth application and sleep health education
* Device: Simplified mHealth application and sleep health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth application<br>Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 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. | Device: mHealth application and sleep health education<br>* 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<br>|
| Experimental: Control Group<br>Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity. | Device: Simplified mHealth application and sleep health education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility/Acceptability benchmark - Enrollment and retention percentages | To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period. | 6 weeks following enrollment | 
| Feasibility/Acceptability benchmarks - 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. | 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 | 6 weeks following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | Validated measure of difficulty falling and staying asleep and subsequent daytime function | At enrollment and 6 weeks following enrollment | 
| Structured Clinical Interview for Sleep Disorders - Revised Edition | Assessment for sleep disorders based on the DSM-5 | At enrollment and 6 weeks following enrollment | 
| Insomnia Severity Index | Global sleep quality; the most common self-reported sleep measure | At enrollment and 6 weeks following enrollment | 
| Daily Sleep Diary - Sleep Onset Latency | Subjective sleep onset latency (time to fall asleep) | Through study completion of 6 weeks | 
| Daily Sleep Diary - Wake-time After Sleep | Subjective time awake after sleep onset | Through study completion of 6 weeks | 
| Daily Sleep Diary - Total Sleep Time | Subjective total sleep time | Through study completion of 6 weeks | 
| Daily Sleep Diary - Sleep Efficiency | Subjective sleep efficiency | Through study completion of 6 weeks |