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

Not Applicable

Not yet recruiting

• Conditions: Poor Quality Sleep; Opioid Use Disorder
• Interventions: Device: mHealth application and sleep health education; Device: Simplified mHealth application and sleep health education

• Registration Number: NCT06157840
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Study Start: 2025-07-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth application	mHealth application and sleep health education	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.
Control Group	Simplified mHealth application and sleep health education	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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