Recruiting

Digital Wellness

Sponsor:

Yale University

Code:

NCT05810259

Conditions

Wellness

Quality of Life

Anxiety

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Caravan Wellness app

Study Details

Brief 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.

Conditions

Wellness

Quality of Life

Anxiety

Depression

Study ID

NCT05810259

Start date

May 22, 2024

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mindfulness

Participants will take part in 7 repeating digital mindfulness modules using the Caravan Wellness App.

experimental: Light to Moderate Physical Activity

Participants will take part in 7 repeating light to moderate physical activity digital wellness modules using the Caravan Wellness App.

no intervention: Control

A no intervention group that will not be using the Caravan Wellness App.

Interventions

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 outcome measure

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

Central Contacts and Locations

Central contacts

David Klemanski, Psy.D., MPH

203.214.5426david.klemanski@yale.edu

Margaret T Davis

margaret.t.davis@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • digital wellness interventions
  • wellness
  • mental health
  • mindfulness
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-29.