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

Last updated: May 27, 2026
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Depression

Treatment

Caravan Wellness app

Clinical Study ID

NCT05810259
2000034914
000
No NIH funding
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Resides in United States

Exclusion

Exclusion Criteria:

  • Any individual who endorses any of the following criteria will be excluded fromparticipation in this study:

  • Positive Health Screening Questions, as measured by the Health ScreeningQuestionnaire (HSQ):

  • Pain, discomfort or pressure in the chest, difficulty breathing or shortness ofbreath, dizziness, fainting, or blackout, blood pressure with systolic greaterthan 140 or diastolic greater than 90, diagnosed or treated for any heartdisease, heart murmur, chest pain (angina), palpitations (irregular beat), orheart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, orheart transplant, resting pulse greater than 100 beats per minute, anyarthritis, back trouble, hip /knee/joint /pain, or any other bone or jointcondition, personal experience or doctor's advice of any other medical orphysical reason that would prohibit the participant from doing light tomoderate physical exercise, personal physician's recommendation againstparticipating 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) cutoffscore > 6

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Caravan Wellness app
Phase:
Study Start date:
May 22, 2024
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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