Меню
Идёт набор NCT07130734

Digital Intervention for Physical Activity

Без фазы С лечением Depression - Major Depressive Disorder Anxiety Stress

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: Digital Physical Activity.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder, Anxiety, Stress. Базовые параметры: 19 лет — 40 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 →
Официальное название

Digitally-Delivered Intervention to Prompt Physical Activity

Обзор

The present study will assess the effects of a four-week digitally delivered intervention on physical activity and depressive symptoms among adults experiencing at least moderate depressive symptoms. The main questions this research aims to answer are: * Does a digitally-delivered intervention increase physical activity levels? * Does a digitally-delivered intervention reduce symptoms of depression? Researchers will compare an intervention promoting physical activity to a passive control (does not receive the intervention) group to see if the intervention reduces depressive symptoms and increases physical activity levels. Participants will: * Visit the laboratory at two separate time points before group assignment, separated by one week of physical activity monitoring * Be randomly assigned to complete four weeks of a digital intervention prompting engagement in physical activity or have their mental health symptoms monitored over four weeks (i.e., passive control group) * Visit the laboratory at two separate time points after the intervention, separated by one week of physical activity monitoring

Подробное описание

Procedures include four laboratory visits: two visits before the intervention and two visits after the intervention.

Participants will be randomly assigned to either four weeks of a digital intervention that prompts participants to engage in physical activity or a waitlist (passive) control condition. Participants will be randomized using a stratified approach using depressive symptoms and physical activity measured at pre-intervention as strata.

The digital intervention group will be instructed to download a Pathverse mobile application on their Apple or Android smartphone device. The Pathverse mobile application will be used as a research delivery platform that can send participants daily push notifications to engage in physical activity of their choice. During the second pre-intervention visit, each participant will select approximately five types of physical activity they find enjoyable that they would like to engage in over the four-week intervention. Participants will report on the physical activity they completed, along with the duration and intensity of each activity. Participants will have the choice of time of day as to when they would like to receive daily notifications on their device.

Members of the passive control group will be informed that their mental health will be monitored over four weeks as a control condition. After the study, they will be offered the digital PA intervention, if desired.

Вмешательства

  • Поведенческое Digital Physical Activity
    The Pathverse mobile application platform will be downloaded on each participant's smartphone. Participants will be guided on how to download and use the application, as well as how to interact with the application during the intervention period. Participants will choose approximately five types of physical activity they enjoy before the intervention and will be prompted to complete these physical activities throughout the intervention. Participants will also self-report the duration and type of

Первичные конечные точки

  • Depressive Symptoms [Срок оценки: pre-intervention, at the two-week time point during the intervention, and immediately after the intervention]
  • Moderate-to-vigorous physical activity [Срок оценки: pre-intervention and immediately after the intervention]

Критерии участия

Критерии включения

  • Between the ages of 19 and 40 years
  • Verbally fluent in English (i.e., must be able to speak or understand English)
  • No uncorrected visual or hearing impairment
  • Moderate depressive symptoms or greater of at least 10 or higher on the Patient Health Questionnaire-8 screening instrument
  • Eligible to participate in physical activity
  • Physically inactive (i.e., engaging in less than 150 min of weekly moderate-to-vigorous physical activity)
  • Owns an Apple or Android mobile device, willing to download the Pathverse app , and willing to keep the device on during the study period
  • Not currently pregnant

Критерии исключения

\- Participants will not qualify for the current study if they do not meet the above inclusion criteria.

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
  • Kinesiology Building — Auburn

Идентификаторы

NCT: NCT07130734 · 00000675

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗