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

NCT ID: NCT05810259

Last Updated: 2025-02-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Wellness Quality of Life Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mindfulness

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

Group Type EXPERIMENTAL

Caravan Wellness app

Intervention Type 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

Participants will take part in 7 repeating light to moderate physical activity digital wellness modules using the Caravan Wellness App.

Group Type EXPERIMENTAL

Caravan Wellness app

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Caravan Wellness

UNKNOWN

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Klemanski, Psy.D., MPH

Role: CONTACT

203.214.5426

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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