Recruiting

COMET

Sponsor:

University of Pennsylvania

Code:

NCT04586192

Conditions

Depressive Symptoms

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Common Elements Toolbox- Adult version (COMET-A)

Self-awareness Control

Study Details

Brief 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

Study ID

NCT04586192

Start date

Jan 31, 2021

Status verified date

Oct, 2021

Completion date

Jun 1, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: COMET

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).

sham comparator: Self-Awareness Control

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

no intervention: Waitlist

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Up to 12 weeks post-intervention ]
  • Change in Generalized Anxiety Disorder Screener-7 (GAD-7) [ Time Frame: Up to 12 weeks post-intervention ]
  • Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) [ Time Frame: Up to 12 weeks post-intervention ]
  • Ratings of Acceptability of Intervention Measure (AIM) [ Time Frame: Immediately after the intervention ]
  • Mechanism Questions [ Time Frame: Up to 12 weeks post-intervention ]
  • Ability to Cope with COVID-19 [ Time Frame: Up to 12 weeks post-intervention ]
  • Secondary Control [ Time Frame: Up to 12 weeks post-intervention ]
  • Perceived Utility [ Time Frame: Immediately after the intervention ]

Central Contacts and Locations

Central contacts

Akash Wasil

6317669466akashwasil133@gmail.com

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 4, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2021-10-04.