Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caravan Wellness app.
- Who it may be relevant to
- Registry conditions: Wellness, Quality of Life, Anxiety, Depression. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial
Overview
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.
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 outcome measures
- 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]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Yale University — New Haven
Identifiers
NCT: NCT05810259 · 2000034914 · 000