Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mHealth application and sleep health education, Simplified mHealth application and sleep health education.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Poor Quality Sleep. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
Overview
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
- 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.
Primary outcome measures
- Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages [Time frame: 6 weeks following enrollment]
- Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement [Time frame: 6 weeks following enrollment]
- mHealth App Usability Questionnaire [Time frame: 6 weeks following enrollment]
Secondary outcome measures (7)
- Pittsburgh Sleep Quality Index [Time frame: At enrollment and 6 weeks following enrollment]
- Structured Clinical Interview for Sleep Disorders - Revised Edition [Time frame: At enrollment and 6 weeks following enrollment]
- Insomnia Severity Index [Time frame: At enrollment and 6 weeks following enrollment]
- Daily Sleep Diary - Sleep Onset Latency [Time frame: Through study completion of 6 weeks]
- Daily Sleep Diary - Wake-time After Sleep [Time frame: Through study completion of 6 weeks]
- Daily Sleep Diary - Total Sleep Time [Time frame: Through study completion of 6 weeks]
- Daily Sleep Diary - Sleep Efficiency [Time frame: Through study completion of 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06157840 · Pro128158 · 1R34DA058511