NCT05810259

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

Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Wellness
• Quality of Life
• Anxiety
• Depression

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-05-22
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-04-12
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study