MOUD の薬物療法中に使用するための mHealth 行動睡眠医学介入の開発
オピオイド使用障害の薬物療法中に使用するための mHealth 行動睡眠薬介入の開発
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Allison K Willkerson, Ph.D.
- 電話番号：843-792-4636
- メール：wilkersa@musc.edu
研究連絡先のバックアップ
- 名前：Jacelyn Lane
- メール：lanejac@musc.edu
研究場所
-
-
South Carolina
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Charleston、South Carolina、アメリカ、29464
- 募集
- Medical University of South Carolina
-
コンタクト：
- Allison Wilkerson, PhD
- 電話番号：843-792-4636
- メール：wilkersa@musc.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
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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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
時間枠：6 weeks following enrollment
|
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period. |
6 weeks following enrollment
|
|
Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pittsburgh Sleep Quality Index
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Through study completion of 6 weeks
|
Subjective time awake after sleep onset |
Through study completion of 6 weeks
|
|
Daily Sleep Diary - Total Sleep Time
時間枠：Through study completion of 6 weeks
|
Subjective total sleep time |
Through study completion of 6 weeks
|
|
Daily Sleep Diary - Sleep Efficiency
時間枠：Through study completion of 6 weeks
|
Subjective sleep efficiency |
Through study completion of 6 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MOUD and drug use
時間枠：Through study completion of 6 weeks
|
Self-reported checklist |
Through study completion of 6 weeks
|
協力者と研究者
捜査官
- 主任研究者：Allison K Wilkerson, Ph.D.、Medical University of South Carolina
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。