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

University of Pennsylvania

Status: Unknown

Conditions: Depressive Symptoms; Anxiety

Treatments: Other: Self-awareness Control; Other: Common Elements Toolbox- Adult version (COMET-A)

Study type: Interventional

Funder types: Other

Identifiers

NCT04586192

30845924

Details and patient eligibility

About

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).

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adult participants (at least 18 years old) will be eligible for this study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

2,500 participants in 3 patient groups

COMET

Experimental group

Description:

Participants receive modules focused on cognitive restructuring, gratitude, behavioral activation and self-compassion. Participants were randomized to receive 3 of the 4 possible modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion.Participants in the intervention condition were randomized to receive descriptions of the four modules at the beginning of the intervention that were phrased to focus on building and improving strengths (positive) or reducing negative emotions and behaviors (negative).

Treatment:

Other: Common Elements Toolbox- Adult version (COMET-A)

Self-Awareness Control

Sham Comparator group

Description:

Participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.

Treatment:

Other: Self-awareness Control

Waitlist

No Intervention group

Description:

Participants filled out all pre-test and post-test measures without having access to COMET of the active control exercises. Participants in this condition will receive access to COMET at the end of the study.