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Идёт набор NCT06963463

Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)

Без фазы С лечением Sleep Disturbance Sleep Depression Suicide

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: TranS-C, Sleep Feedback.
Кому может быть актуально
Состояния в реестре: Sleep Disturbance, Sleep, Depression, Suicide. Базовые параметры: 12 лет — 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

Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression

Обзор

The goal of this clinical trial is to adapt a sleep intervention for individuals representative of all demographic groups, including those who are at the highest risk for suicidal behavior. Sleep difficulties are a promising target for youth with suicidal thoughts and behavior to focus on as a prevention measure. We aim to increase intervention acceptability and impact by adapting it for the adolescent populations at highest risk for suicidal thoughts and behavior. The research project will compare Transdiagnostic Sleep and Circadian Intervention (TranS-C), an evidence based, modularized intervention that targets a range of sleep difficulties to a treatment as usual or control condition including providing weekly sleep feedback reports from data entered into a daily sleep diary and from wearing a sleep sensing, actigraphy watch. Participants in both conditions (TranS-C vs. Sleep Feedback) will wear an actigraphy sleep watch that monitors sleep, and complete daily sleep diaries via smartphone or email. Participants in the TranS-C condition will also wear bright light (BL) and blue blocking glasses each day as well as attend weekly or biweekly sessions with a Sleep Therapist. The sleep therapist will review sleep feedback during sessions.

Подробное описание

This study will adapt TranS-C+BL for at-risk adolescents using health equity-informed implementation science methods.

This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinically significant sleep difficulties identified in primary care. The randomization that this study uses is a 2:1 allocation to compare TranS-C+BL Sleep Feedback vs. Sleep Feedback Alone.

Вмешательства

  • Поведенческое TranS-C
    This intervention includes participants attending 6-8 sessions with a Sleep Therapist.
  • Поведенческое Sleep Feedback
    Participants are provided with an actigraphy watch that is used to monitor their sleep and activity throughout the day and complete a sleep diary daily. Along with wearing the watch they also will be provided access to their actigraphy and sleep diary graphs that document their data.

Первичные конечные точки

  • Feasibility-Attendance [Срок оценки: From enrollment to the end of the treatment (up to 4 months)]
  • Feasibility-Attrition [Срок оценки: From enrollment until withdrawal or completing treatment sessions.]
  • Acceptability-Treatment Satisfaction [Срок оценки: 4 month]
Вторичные конечные точки (9)
  • Sleep Disturbance [Срок оценки: Baseline]
  • Depression [Срок оценки: Baseline]
  • Risk for Suicidal Thoughts and Behaviors [Срок оценки: Baseline]
  • Sleep Disturbance [Срок оценки: 1 month]
  • Sleep Disturbance [Срок оценки: 4 months]
  • Depression [Срок оценки: 1 month]
  • Depression [Срок оценки: 4 month]
  • Risk for Suicidal Thoughts and Behaviors [Срок оценки: 1 month]
  • Risk for Suicidal Thoughts and Behaviors [Срок оценки: 4 month]

Критерии участия

Критерии включения

  • Adolescents (12-18)
  • Current moderate to severe depression as measured by the PHQ-9M with a total score of greater than or equal to 11
  • Current clinically significant sleep disturbance measured by the PHQ-9-M sleep item greater than or equal to 2.
  • English language fluency and literacy sufficient to engage in study protocol.

Критерии исключения

  • Evidence of obstructive sleep apnea,
  • Evidence of restless legs syndrome
  • Evidence of psychosis
  • Evidence of bipolar disorder
  • Evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening.

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Childrens Hospital of Philadelphia — Philadelphia
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06963463 · STUDY22040040 · P50MH115838

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗