WellnessNCT05810259
Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life
A study testing Caravan Wellness app in people with Wellness and Quality of Life, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellness, Quality of Life, Anxiety
- What is being tested?
- Caravan Wellness app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resides in United States
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Margaret T Davis contact
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06520
About this study
Official title: Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial
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.
Read the 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.
- Conditions
- Wellness, Quality of Life, Anxiety, Depression
- Being tested
- Caravan Wellness app
- Keywords
- digital wellness interventions, wellness, mental health, mindfulness, exercise
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caravan Wellness appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Participants will take part in 7 repeating digital mindfulness modules using the Caravan Wellness App. Receives: Device: Caravan Wellness app |
| Light to Moderate Physical Activity | Experimental | Participants will take part in 7 repeating light to moderate physical activity digital wellness modules using the Caravan Wellness App. Receives: Device: Caravan Wellness app |
| Control | No intervention | A no intervention group that will not be using the Caravan Wellness App. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
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.
Measured: baseline, 1 Month follow up, 3 Month follow up
Change in Exercise Behavior assessed by the Behavior Regulation Exercise Questionnaire, Third Version (BREQ-3)
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.
Measured: baseline, 1 Month follow up, 3 Month follow up
Utility of the Modules assessed by self report
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).
Measured: up to Day 22
Daily stressors assessed using the Brief Daily Stressors Screening Tool (BDSST)
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.
Measured: up to Day 22
Average number of minutes spent on Intervention
The average number of minutes per day spent on Intervention, as measured by self-report.
Measured: up to Day 22
Change in health behavior motivation assessed using the Health Behavior Motivation Scale (HBMS)
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.
Measured: baseline, 1 Month follow up, 3 Month follow up
CHange in health behavior assessed using he Health Behavior Inventory-20 (HBI-20).
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.
Measured: baseline, 1 Month follow up, 3 Month follow up
Quality of life assessed using the Quality of Life Inventory (QOLI)
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.
Measured: 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)
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+).
Measured: baseline, 1 Month follow up, 3 Month follow up
Secondary outcomes (2)
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is designed to evaluate overall sleep quality in clinical and non-clinical populations. The measure includes 19 self-reported items belonging to one of seven subcategories, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The questionnaire consists of a combination of Likert- type and openended questions (later converted to scaled scores using provided guidelines). Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Measured: baseline, 1 Month follow up, 3 Month follow up
Physical activity assessed using the International Physical Activity Questionnaire, Long Form (IPAQ-LF).
The IPAQ-LF is a 27-item survey that assesses the types of intensity of physical activity and sitting time. The scale asks respondents to rate during the last seven days engagement with physical activities.
Measured: up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start22 May 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Caravan Wellness
- Responsible party
- Sponsor
- Investigators
- David Klemanski, Psy.D., MPH, Principal investigator, Yale UniversityMargaret T Davis, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810259
- Sponsor's protocol ID
- 2000034914
- Other IDs
- 000
- Status last verified
- May 2026
- First submitted
- 30 Mar 2023
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05810259
- Acronym / sponsor ID
- 2000034914
- Conditions
- Wellness, Quality of Life, Anxiety, Depression
- Keywords
- digital wellness interventions, wellness, mental health, mindfulness, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Caravan Wellness
- Study start
- 22 May 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Device: Caravan Wellness appParticipants will take part in 7 repeating digital mindfulness modules using the Caravan Wellness App. |
| Light to Moderate Physical Activity | Experimental | Device: Caravan Wellness appParticipants will take part in 7 repeating light to moderate physical activity digital wellness modules using the Caravan Wellness App. |
| Control | No intervention | –A no intervention group that will not be using the Caravan Wellness App. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resides in United States
Key exclusion criteria (9 listed)
- 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):
- Positive Psychiatric Disorders Screening Questions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caravan Wellness appCaravan 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. | Device | Light to Moderate Physical Activity, Mindfulness |
Primary outcome
Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 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)
Time frame: 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 report
Time frame: up 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)
Time frame: 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 Intervention
Time frame: up 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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+).
2 secondary outcomes
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, 1 Month follow up, 3 Month follow up
Physical activity assessed using the International Physical Activity Questionnaire, Long Form (IPAQ-LF).
Time frame: up to Day 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret T Davis contact
David Klemanski, Psy.D., MPH principal investigator
Yale University
Margaret T Davis, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caravan Wellness app in people with Wellness and Quality of Life, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Klemanski, Psy.D., MPH (203.214.5426, david.klemanski@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.