MOUD에 대한 약물 보조 치료 중 사용할 수 있는 mHealth 행동 수면 의학 중재 개발
오피오이드 사용 장애에 대한 약물 보조 치료 중 사용하기 위한 mHealth 행동 수면 의학 중재 개발
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Allison K Willkerson, Ph.D.
- 전화번호: 843-792-4636
- 이메일: wilkersa@musc.edu
연구 연락처 백업
- 이름: Jacelyn Lane
- 이메일: lanejac@musc.edu
연구 장소
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South Carolina
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Charleston, South Carolina, 미국, 29464
- 모병
- Medical University of South Carolina
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연락하다:
- Allison Wilkerson, PhD
- 전화번호: 843-792-4636
- 이메일: wilkersa@musc.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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No experience of withdrawal symptoms in past 2 weeks
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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)
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Currently experiencing clinically significant sleep disturbance (PSQI > 5)
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Able to read and understand English
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Owns an Android or iOS smartphone
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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 |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
기간: 6 weeks following enrollment
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To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period. |
6 weeks following enrollment
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Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
기간: 6 weeks following enrollment
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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
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mHealth App Usability Questionnaire
기간: 6 weeks following enrollment
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Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness |
6 weeks following enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pittsburgh Sleep Quality Index
기간: At enrollment and 6 weeks following enrollment
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Validated measure of difficulty falling and staying asleep and subsequent daytime function |
At enrollment and 6 weeks following enrollment
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Structured Clinical Interview for Sleep Disorders - Revised Edition
기간: At enrollment and 6 weeks following enrollment
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Assessment for sleep disorders based on the DSM-5 |
At enrollment and 6 weeks following enrollment
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Insomnia Severity Index
기간: At enrollment and 6 weeks following enrollment
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Global sleep quality; the most common self-reported sleep measure |
At enrollment and 6 weeks following enrollment
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Daily Sleep Diary - Sleep Onset Latency
기간: Through study completion of 6 weeks
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Subjective sleep onset latency (time to fall asleep) |
Through study completion of 6 weeks
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Daily Sleep Diary - Wake-time After Sleep
기간: Through study completion of 6 weeks
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Subjective time awake after sleep onset |
Through study completion of 6 weeks
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Daily Sleep Diary - Total Sleep Time
기간: Through study completion of 6 weeks
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Subjective total sleep time |
Through study completion of 6 weeks
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Daily Sleep Diary - Sleep Efficiency
기간: Through study completion of 6 weeks
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Subjective sleep efficiency |
Through study completion of 6 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MOUD and drug use
기간: Through study completion of 6 weeks
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Self-reported checklist |
Through study completion of 6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Allison K Wilkerson, Ph.D., Medical University of South Carolina
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro128158
- 1R34DA058511 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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