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Идёт набор NCT06626425

Well-being Training for Adolescent Depressive Symptoms (TeenWell Study)

Без фазы С лечением Depression

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: Healthy Minds Program App, Hydro Coach App.
Кому может быть актуально
Состояния в реестре: Depression. Базовые параметры: 14 лет — 19 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

Smartphone-based Meditation Training to Reduce Adolescent Depression

Обзор

This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms. Up to 200 participants will be on study for 20 weeks.

Подробное описание

Participants will be randomized into one of two groups: Healthy Minds Program intervention group (HMP) or a water tracking active control group. The groups will use different mobile health apps for eight weeks. All participants will complete assessments pre-intervention, after weeks 2, 4, and 6 of the intervention, at week 8 (post-intervention), and at week 20 (follow-up). Participants will complete a short daily diary set of questions on their social interactions that day. Participants will wear a Biostrap band for continuous collection of heart rate, movement, and daily sleep indices, and geolocation data will be extracted from participant phones using the FollowMee app. Participants will receive access to the app they were not assigned to after follow-up.

Primary Objective

* Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms.

Secondary Objectives

* Investigate effects of the meditation training program on symptoms of anxiety, behavior (social isolation), psychophysiological processes related to health and disease (e.g., sleep). Test changes in behavior and psychophysiology as mechanisms of improved mental health. Test whether improved mental health is associated with improved academic outcomes.

Вмешательства

  • Другое Healthy Minds Program App
    An 8-week meditation-based well-being training containing content for each of the four pillars of the training program: Awareness, Connection, Insight, and Purpose.
  • Другое Hydro Coach App
    The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration.

Первичные конечные точки

  • PROMIS Pediatric Depression T-Scores [Срок оценки: 8 weeks, 20 weeks]
Вторичные конечные точки (12)
  • PROMIS Pediatric Anxiety T-Scores [Срок оценки: 8 weeks, 20 weeks]
  • EPOCH Wellbeing Scores [Срок оценки: 8 weeks, 20 weeks]
  • PROMIS Pediatric Sleep Disturbance T-Score [Срок оценки: 8 weeks, 20 weeks]
  • Sleep Duration assessed with wearable device [Срок оценки: Daily through 20 weeks]
  • Sleep Staging assessed with wearable device [Срок оценки: Daily through 20 weeks]
  • Wake after sleep onset [Срок оценки: Daily through 20 weeks]
  • Pulse Rate Variability (PRV) collected by a wearable sensor [Срок оценки: Daily through 20 weeks]
  • Belonging Uncertainty Scale Score [Срок оценки: 8 weeks, 20 weeks]
  • Drexel Defusion Teen Score [Срок оценки: 8 weeks, 20 weeks]
  • NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form [Срок оценки: 8 weeks, 20 weeks]
  • Perseverative Thinking Questionnaire - Child Scores [Срок оценки: 8 weeks, 20 weeks]
  • Healthy Minds Index [Срок оценки: 8 weeks]

Критерии участия

  • Age 14 to 19
  • Currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled
  • Proficient in English
  • Able to understand and provide informed consent (greater than or equal to 18 years old) or assent and parent/guardian consent (if less than 18 years old)
  • PROMIS Depression Scale T-score greater than or equal to 60
  • If on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks
  • Willing and able to complete all study procedures

Критерии исключения

  • Has received a high school diploma or a high school equivalency diploma (HSED or GED)
  • Weekly or more frequent meditation practice
  • Prior use of the Healthy Minds Program app
  • Prior use of the water tracking app
  • Endorses current active suicidal ideation with intent on the baseline screen
  • Self-reported history of psychosis or mania
  • Practiced the techniques learned in a mindfulness-based therapy Acceptance Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), Mindfulness-Based Stress Reduction (MBSR) etc. one or more times per week in the last 6 months. Include therapy sessions if mindfulness is practiced in session or planning to start one of these therapies during the study period.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Center for Healthy Minds, University of Wisconsin Madison — Madison

Идентификаторы

NCT: NCT06626425 · 2023-0554 · 1K01MH130752-01A1 · A483000 · Protocol Version 5/22/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗