Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life
NCT ID: NCT05810259
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-05-22
2025-12-31
Brief Summary
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Detailed Description
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The study will be conducted virtually by Yale University researchers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Mindfulness
Participants will take part in 7 repeating digital mindfulness modules using the Caravan Wellness App.
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.
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.
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.
Control
A no intervention group that will not be using the Caravan Wellness App.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Caravan Wellness
UNKNOWN
Yale University
OTHER
Responsible Party
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Principal Investigators
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David Klemanski, Psy.D., MPH
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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000
Identifier Type: OTHER
Identifier Source: secondary_id
2000034914
Identifier Type: -
Identifier Source: org_study_id
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