Recruiting

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

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.

ClinicalTrials.gov IDNCT05810259

PhaseNA

Enrollment120

SponsorYale University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Wellness, Quality of Life, Anxiety, Depression

About this study

Interventions

Device: 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.

Primary outcomes

Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) (baseline, 1 Month follow up, 3 Month follow up)
Change in Exercise Behavior assessed by the Behavior Regulation Exercise Questionnaire, Third Version (BREQ-3) (baseline, 1 Month follow up, 3 Month follow up)
Utility of the Modules assessed by self report (up to Day 22)
Daily stressors assessed using the Brief Daily Stressors Screening Tool (BDSST) (up to Day 22)
Average number of minutes spent on Intervention (up to Day 22)
Change in health behavior motivation assessed using the Health Behavior Motivation Scale (HBMS) (baseline, 1 Month follow up, 3 Month follow up)
CHange in health behavior assessed using he Health Behavior Inventory-20 (HBI-20). (baseline, 1 Month follow up, 3 Month follow up)
Quality of life assessed using the Quality of Life Inventory (QOLI) (baseline, 1 Month follow up, 3 Month follow up)

Eligibility information

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

Study locations

Yale University, New Haven, Connecticut 06520 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.