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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Depressive Symptoms
• Intervention / Treatment: Other: Common Elements Toolbox- Adult version (COMET-A); Other: Self-awareness Control

• Study Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akash Wasil; Phone Number: 6317669466; Email: akashwasil133@gmail.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)	Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.	Up to 12 weeks post-intervention
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)	Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.	Up to 12 weeks post-intervention
Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)	Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.	Up to 12 weeks post-intervention
Ratings of Acceptability of Intervention Measure (AIM)	Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.	Immediately after the intervention
Mechanism Questions	Participants answered questions relating to each module's mechanism of change on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants: How capable they feel about managing negative thoughts; If they will intentionally spend time doing activities they enjoy; If they will notice and appreciate good things; If they will be able to treat themselves with empathy and compassion	Up to 12 weeks post-intervention
Ability to Cope with COVID-19	2 questions related to their ability to cope with stressors over the upcoming weeks (including challenges relating to COVID-19). Participants answered these questions on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants: if they will be able to handle lifestyle changes due to the coronavirus,; if the pandemic will have an extremely negative impact on their life.	Up to 12 weeks post-intervention
Secondary Control	We asked participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). The three items are: When something bad happens, I can find a way to think about it that makes me feel better.; After a really hard day, I can make myself feel better by remembering some good things that happened.; When bad things happen to me that I can't control, there are lots of things I can do to feel better. Higher scores will indicate greater secondary control.	Up to 12 weeks post-intervention
Perceived Utility	Participants were asked to rate three items relating to the perceived utility of each module. Specifically, we asked participants: How helpful the module was; How engaging the module was; How much they will continue applying content from the module Higher scores will indicate greater perceived utility.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Study Director: Robert J DeRubeis, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 30845924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No