Digital Wellness Modules for Quality of Life and Anxiety

This study is testing if using the Caravan Wellness app, which offers digital mindfulness and exercise modules, can improve your quality of life and reduce stress, anxiety, and depression. Researchers want to see if these modules can help you change your health behaviors. You might be able to join if you are between 18 and 65 years old, live in the United States, and don't have certain health conditions like chest pain or dizziness. The study will measure changes in your mindfulness and exercise habits over 1 and 3 months to see how effective the app is. The study is currently recruiting 120 participants.

Study design
This is a longitudinal study with 120 participants, comparing different groups using the digital wellness modules. It is an interventional study, meaning participants will receive a specific intervention.
What's involved
You will use the Caravan Wellness app and complete self-report assessments at the start of the study, after 1 month, and after 3 months. You will also report on the utility of the modules for up to 22 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for 3 months after starting the study.

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NCT05810259

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

Recruiting
NAAges 18–65InterventionalPrevention
Yale University
~120 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Caravan Wellness app

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
Measured over baseline, 1 Month follow up, 3 Month follow up
+8 more outcomes measured
Wellness
Quality of Life
Anxiety
Depression
1 sites across 1 states
Connecticut1
  • David Klemanski, Psy.D., MPH · PRINCIPAL_INVESTIGATOR · Yale University
  • Margaret T Davis, MD · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

Resides in United States

Exclusion

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
  • Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)baseline, 1 Month follow up, 3 Month follow up

    The FFMQ is a 39-item questionnaire created to further explore the facet structure of mindfulness in daily life as a construct. It is composed of five component skills which contribute to mindfulness, non-reactivity to inner experiences (7 items), observing (8 items), acting with awareness (8 items), non-judging of inner experiences (8 items), and describing (8 items). Items are rated on a 5-point Likert- type scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate more mindfulness.

  • Change in Exercise Behavior assessed by the Behavior Regulation Exercise Questionnaire, Third Version (BREQ-3)baseline, 1 Month follow up, 3 Month follow up

    The BREQ-3 is a 24-item scale with five factors that measure external, introjected, identified, and intrinsic forms of regulation of exercise behavior based on Deci \& Ryan's continuum conception of extrinsic and intrinsic motivation, described by organismic integration theory. Each item is scored on a five-point Likert scale, ranging from 0 ("Strongly Disagree") to 4 ("Strongly Agree"). Higher scores indicate an increase in exercise.

  • Utility of the Modules assessed by self reportup to Day 22

    Perceived utility of the modules will be assessed by self report using a one-item 5-point Likert scale = 0 (strongly disagree), 1 (disagree), 2 (agree), 3 (strongly agree), or 4 (undecided).

  • Daily stressors assessed using the Brief Daily Stressors Screening Tool (BDSST)up to Day 22

    Daily stressors will be assessed using the BDSST, a short instrument for the recording of perceived general daily stressors in eight different areas of life. It is particularly suitable for use in large-scale studies or as a screening instrument for localizing areas of life where stress is particularly prevalent. A five-point Likert scale is used to measure the extent of the perceived stress experience from 0 ("Not at all") to 4 ("Very much") The higher the score, the more pronounced the subjective experience of general everyday stress.

  • Average number of minutes spent on Interventionup to Day 22

    The average number of minutes per day spent on Intervention, as measured by self-report.

  • 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 motivation will be measured using the HBMS, a 30-item, five-point Likert scale that has a five-dimensional structure (i.e., intrinsic regulation, integrated and identified regulation, introjected regulation, external regulation, and amotivation). Scale ranges from 1 ("Definitely disagree") to 5 ("Definitely agree"). Higher scores indicate more health behavior motivation.

  • CHange in health behavior assessed using he Health Behavior Inventory-20 (HBI-20).baseline, 1 Month follow up, 3 Month follow up

    Health behavior change will be measured using the HBI-20. The measure consists of a 20-items that factor into five subscales. Three subscales reflect health-promoting behaviors: Diet (five items), Preventive Care (seven items), and Medical Compliance (two items), and two subscales reflect health risk behaviors: Anger and Stress (three items), and Substance Use (three items). The health risk items are reverse-scored so that high scores on all subscales indicate a greater degree of health promotion and risk avoidance. Respondents are asked to rate the extent to which each item was self-descriptive, using a 7-point scale (e.g., 1 = always through 7 =never). Subscale scores are obtained by summing participants' responses (after reverse coding the risk items) and dividing them by the number of items.

  • Quality of life assessed using the Quality of Life Inventory (QOLI)baseline, 1 Month follow up, 3 Month follow up

    The QOLI has 16 well-defined domains: health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood, and community. Within each domain, respondents are asked to rate the importance of that domain to their happiness on a 3-point scale: 0 = Not important, 1 = Important, and 2 = Extremely important. They then rate their satisfaction with each domain from -3 = Extremely, -2 = Somewhat, and -1 = A little dissatisfied to +1 = A little, +2 = Somewhat, and +3 = Extremely satisfied for each domain. The QOLI is scored by multiplying importance scores by satisfaction scores for each of the 16 domains, and then calculating an average across domains.

  • Change in stress and non-pathological anxiety and depression assessed using the Depression, Anxiety, and Stress Scale (DASS-21)baseline, 1 Month follow up, 3 Month follow up

    The DASS-21 assesses key symptoms of depression, anxiety, and stress.The 21 items on the questionnaire comprise a set of three scales designed to assess depression, anxiety, and stress. The seven elements on each scale are rated on a Likert scale from 0 to 3 (0: "Did not apply to me at all," 1: "Applied to me to some degree or some of the time," 2: "Applied to me to a considerable degree or a good part of the time," and 3: "Applied to me very much or most of the time"). Scale scores are measured by summarizing the scores of the related items and then multiplying them by 2 to calculate the final score. Resulting ratings are then classified as: Depression: normal (0-4), mild (5-6), moderate (7-10), severe (11-13), or extremely severe (14+); Anxiety: normal (0-3), mild (4-5), moderate (6-7), severe (8-9), extremely severe (10+); Stress: normal (0-7), mild (8-9), moderate (10-12), severe (13-16), extremely severe (17+).