NCT05810259NARecruitingAccepts Healthy Volunteers

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

Yale University

Start Date

5/22/2024

Completion Date

3/1/2027

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Resides in United States Exclusion Criteria: * 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

Interventions

DEVICE

Caravan Wellness app

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Conditions

WellnessQuality of LifeAnxietyDepression

Locations

Yale University

New Haven, Connecticut 06520

United States