Меню
Идёт набор NCT06829953

Get ActivE Study for At-risk Youth

Без фазы С лечением Anhedonia Depression and Suicide Ideation

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: GET ActivE, Treatment As Usual.
Кому может быть актуально
Состояния в реестре: Anhedonia, Depression and Suicide Ideation. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)

Обзор

The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.

Подробное описание

Aim 3 (Randomized Pilot): To examine implementation outcomes, initial effectiveness, and equity across outcomes in a pilot randomized trial (n=75, 2:1 randomization, 35% Black, 10% Hispanic) of GET ActivE vs. Activity Monitoring Alone. H3a. The study will observe high GET ActivE feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%; response to health coach contacts \>80%); acceptability (\>80%); and appropriateness (\>80%). H3b. Youth who receive GET ActivE will show greater improvement in anhedonia (primary outcome) and H3c. depression severity and suicidal risk (secondary outcomes). H3d. Outcomes will be equitable by race. H3e. Exploratory (mechanistic): GET ActivE will lead to decreased depression and suicidal risk through increased activity and reward responsiveness.

Вмешательства

  • Поведенческое GET ActivE
    The GET ActivE health coach will review data from the Vira app and send nudges to the participant with insights encouraging them to engage in activities that bring enjoyment or pleasure.
  • Поведенческое Treatment As Usual
    Participants randomized to Treatment As Usual may have access to activity data from an app and receive summary information about activity patterns at the end of their participation.

Первичные конечные точки

  • GET ActivE Feasibility [Срок оценки: 3 months]
  • Response to Health coach contacts [Срок оценки: 3 months]
  • GET ActivE Acceptability [Срок оценки: Post intervention follow up; up to 3 months]
  • GET ActivE Appropriateness [Срок оценки: Post intervention follow up; up to 3 months]
Вторичные конечные точки (1)
  • Anhedonia [Срок оценки: baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

  • Adolescents age 12-18
  • Current moderate to severe depression (PHQ-9-M > 11)
  • Current clinically significant anhedonia, operationalized as PHQ-9-M anhedonia item score > 1
  • English language fluency and literacy level sufficient to engage in study protocol
  • Willing to download the app on their smart phones

Критерии исключения

  • Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.

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
  • Children's Hospital of Philadelphia — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh

Идентификаторы

NCT: NCT06829953 · STUDY22040034 · P50MH115838

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗