Разработка вмешательства в области поведенческой медицины сна mHealth для использования во время медикаментозного лечения MOUD
Разработка вмешательства в области поведенческой медицины сна mHealth для использования во время медикаментозного лечения расстройств, вызванных употреблением опиоидов
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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Allison K Willkerson, Ph.D.
- Номер телефона: 843-792-4636
- Электронная почта: wilkersa@musc.edu
Учебное резервное копирование контактов
- Имя: Jacelyn Lane
- Электронная почта: lanejac@musc.edu
Места учебы
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29464
- Рекрутинг
- Medical University of South Carolina
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Контакт:
- Allison Wilkerson, PhD
- Номер телефона: 843-792-4636
- Электронная почта: wilkersa@musc.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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 |
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pittsburgh Sleep Quality Index
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Through study completion of 6 weeks
|
Subjective total sleep time |
Through study completion of 6 weeks
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Daily Sleep Diary - Sleep Efficiency
Временное ограничение: Through study completion of 6 weeks
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Subjective sleep efficiency |
Through study completion of 6 weeks
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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MOUD and drug use
Временное ограничение: Through study completion of 6 weeks
|
Self-reported checklist |
Through study completion of 6 weeks
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Соавторы и исследователи
Следователи
- Главный следователь: Allison K Wilkerson, Ph.D., Medical University of South Carolina
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Pro128158
- 1R34DA058511 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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