NCT04586192

Digital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET

Developing and Assessing a Digital Mental Health and Wellness Intervention for Adults: Randomized Control Trial of the Common Elements Toolbox (COMET)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators are evaluating the acceptability and effectiveness of brief online wellness modules. Participants will be randomly assigned to the intervention condition, an active control condition, or a wait-list control condition. The investigators are using a factorial design, such that each participant in the intervention condition will be randomly assigned to receive three of four wellness modules. The investigators will analyze the intervention's effectiveness as a universal intervention (using the full sample) and a targeted intervention (using the subset of the sample that reported elevated depressive symptoms or anxiety symptoms at baseline).

Conditions

• Depressive Symptoms
• Anxiety

Interventions

Type	Name	Description
OTHER	Common Elements Toolbox- Adult version (COMET-A)	COMET includes four different modules that teach participants exercises designed to improve mental health and well-being. Participants are asked to complete exercises focused on behavioral activation, cognitive restructuring, gratitude and self-compassion. At the end of the intervention, participants are sent templates that they can you to complete the exercises on, and are encouraged to continue practicing their exercises in their daily life.
OTHER	Self-awareness Control	A control condition in which participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.

Timeline

• Start date: 2021-01-31
• Primary completion: 2022-01-01
• Completion: 2022-06-01
• First posted: 2020-10-14
• Last updated: 2021-10-04

Locations

1 site across 1 country: United States