NCT06157840

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder
• Poor Quality Sleep

Interventions

Type	Name	Description
DEVICE	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 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
DEVICE	Simplified 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.

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-06-30
• Completion: 2026-07-17
• First posted: 2023-12-06
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States