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Идёт набор NCT06157840

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

Без фазы С лечением Opioid Use Disorder Poor Quality Sleep

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: mHealth application and sleep health education, Simplified mHealth application and sleep health education.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder, Poor Quality Sleep. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

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.

Вмешательства

  • Устройство 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
  • Устройство 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.

Первичные конечные точки

  • Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages [Срок оценки: 6 weeks following enrollment]
  • Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement [Срок оценки: 6 weeks following enrollment]
  • mHealth App Usability Questionnaire [Срок оценки: 6 weeks following enrollment]
Вторичные конечные точки (7)
  • Pittsburgh Sleep Quality Index [Срок оценки: At enrollment and 6 weeks following enrollment]
  • Structured Clinical Interview for Sleep Disorders - Revised Edition [Срок оценки: At enrollment and 6 weeks following enrollment]
  • Insomnia Severity Index [Срок оценки: At enrollment and 6 weeks following enrollment]
  • Daily Sleep Diary - Sleep Onset Latency [Срок оценки: Through study completion of 6 weeks]
  • Daily Sleep Diary - Wake-time After Sleep [Срок оценки: Through study completion of 6 weeks]
  • Daily Sleep Diary - Total Sleep Time [Срок оценки: Through study completion of 6 weeks]
  • Daily Sleep Diary - Sleep Efficiency [Срок оценки: Through study completion of 6 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT06157840 · Pro128158 · 1R34DA058511

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗