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

NCT05810259 | Recruiting FDA Device

• 2 other identifiers: 2000034914000
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wellness; Quality of Life; Anxiety; Depression

Keywords

digital wellness interventions; wellness; mental health; mindfulness; exercise

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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+).

  baseline, 1 Month follow up, 3 Month follow up

Secondary Outcomes (2)

• Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI)

  baseline, 1 Month follow up, 3 Month follow up

• Physical activity assessed using the International Physical Activity Questionnaire, Long Form (IPAQ-LF).

  up to Day 22

Study Arms (3)

Mindfulness

EXPERIMENTAL

Participants will take part in 7 repeating digital mindfulness modules using the Caravan Wellness App.

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.

Device: Caravan Wellness app

Control

NO INTERVENTION

A no intervention group that will not be using the Caravan Wellness App.

Interventions

Caravan Wellness app DEVICE

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; Mindfulness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resides in United States

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Caravan Wellness: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• David Klemanski, Psy.D., MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Klemanski, Psy.D., MPH

CONTACT

203.214.5426; david.klemanski@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: May 22, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)