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

Yale University

Status: Enrolling

Conditions: Quality of Life; Depression; Anxiety; Wellness

Treatments: Device: Caravan Wellness app

Study type: Interventional

Funder types: Other

Identifiers

NCT05810259

2000034914

000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Mindfulness

Experimental group

Description:

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

Treatment:

Device: Caravan Wellness app

Light to Moderate Physical Activity

Experimental group

Description:

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

Treatment:

Device: Caravan Wellness app

Control

No Intervention group

Description:

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