About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Resides in United States
Disqualifiers
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 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
Trial design
Parallel
Treatments tested in this trial
Caravan Wellness app
DeviceCaravan 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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Yale University
Lead sponsor
Caravan Wellness
Collaborator