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

November 27, 2023 updated by: Allison Wilkerson, Medical University of South Carolina

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

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Allison K Willkerson, Ph.D.
  • Phone Number: 843-792-4636
  • Email: wilkersa@musc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mHealth application
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.
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
Experimental: Control Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility/Acceptability benchmark - Enrollment and retention percentages
Time Frame: 6 weeks following enrollment
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period.
6 weeks following enrollment
Feasibility/Acceptability benchmarks - Engagement
Time Frame: 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.
6 weeks following enrollment
mHealth App Usability Questionnaire
Time Frame: 6 weeks following enrollment
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
Time Frame: At enrollment and 6 weeks following enrollment
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
Time Frame: At enrollment and 6 weeks following enrollment
Assessment for sleep disorders based on the DSM-5
At enrollment and 6 weeks following enrollment
Insomnia Severity Index
Time Frame: At enrollment and 6 weeks following enrollment
Global sleep quality; the most common self-reported sleep measure
At enrollment and 6 weeks following enrollment
Daily Sleep Diary - Sleep Onset Latency
Time Frame: Through study completion of 6 weeks
Subjective sleep onset latency (time to fall asleep)
Through study completion of 6 weeks
Daily Sleep Diary - Wake-time After Sleep
Time Frame: Through study completion of 6 weeks
Subjective time awake after sleep onset
Through study completion of 6 weeks
Daily Sleep Diary - Total Sleep Time
Time Frame: Through study completion of 6 weeks
Subjective total sleep time
Through study completion of 6 weeks
Daily Sleep Diary - Sleep Efficiency
Time Frame: Through study completion of 6 weeks
Subjective sleep efficiency
Through study completion of 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOUD and drug use
Time Frame: Through study completion of 6 weeks
Self-reported checklist
Through study completion of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Allison K Wilkerson, Ph.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro128158
  • 1R34DA058511 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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