RecruitingNANCT05810259

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

Sponsor: Yale University

Trial Details

ConditionWellness, Quality of Life, Anxiety, Depression
InterventionCaravan Wellness app
PhaseNA
StatusRecruiting
Participants120
Est. Completion1 Mar 2027
Last Updated29 May 2026

Primary Outcome

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

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

United States
View Registry Entry

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