Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life

Официальное название

Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial

Обзор

The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Подробное описание

Primary Objective: The primary objective of this parallel-assignment longitudinal study is to determine whether the digital wellness modules (e.g., mindfulness and light to moderate physical activity) increase quality of life and decrease stress, anxiety, and depression, as mediated by health behavior motivation and change in a healthy population of adults. Secondary Objective(s): The secondary objective is to ascertain qualitatively through deductive thematic analysis specific themes of a) key drivers of health behavior change; b) types of motivations that drive health behavior change, and c) implementation of sustained health behavior change.

The study will be conducted virtually by Yale University researchers.

Вмешательства

• Устройство Caravan Wellness app
  Caravan Wellness is a digital platform that offers brief mindfulness and light to moderate physical activity modules, among many others (e.g., Pilates, Yoga, Barre, meditation, etc.), to enhance overall individual well-being.

Первичные конечные точки

• Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]
• Change in Exercise Behavior assessed by the Behavior Regulation Exercise Questionnaire, Third Version (BREQ-3) [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]
• Utility of the Modules assessed by self report [Срок оценки: up to Day 22]
• Daily stressors assessed using the Brief Daily Stressors Screening Tool (BDSST) [Срок оценки: up to Day 22]
• Average number of minutes spent on Intervention [Срок оценки: up to Day 22]
• Change in health behavior motivation assessed using the Health Behavior Motivation Scale (HBMS) [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]
• CHange in health behavior assessed using he Health Behavior Inventory-20 (HBI-20). [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]
• Quality of life assessed using the Quality of Life Inventory (QOLI) [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]
• Change in stress and non-pathological anxiety and depression assessed using the Depression, Anxiety, and Stress Scale (DASS-21) [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]

Вторичные конечные точки (2)

• Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: baseline, 1 Month follow up, 3 Month follow up]
• Physical activity assessed using the International Physical Activity Questionnaire, Long Form (IPAQ-LF). [Срок оценки: up to Day 22]

Критерии участия

Критерии включения

• Resides in United States

Критерии исключения

• Any individual who endorses any of the following criteria will be excluded from participation in this study:
• Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ):

• Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia.
• Positive Psychiatric Disorders Screening Questions:

• Positive screen for depression, excluding suicide (PHQ-8) cutoff score > 6
• Positive screen for panic (SMPD) cutoff score > 2
• Positive screen for generalized anxiety (GAD-7) cutoff score > 10
• Positive screen psychosis (PDSQ) via psychosis section, cutoff score > 3
• Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score > 6

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Yale University — New Haven

Идентификаторы

NCT: NCT05810259 · 2000034914 · 000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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