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

NCT04586192 | Unknown

• 1 other identifier: 30845924
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

COMET

EXPERIMENTAL

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)

Self-Awareness Control

SHAM COMPARATOR

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

Other: Self-awareness Control

Waitlist

NO INTERVENTION

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) OTHER

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.

COMET

Self-awareness Control OTHER

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.

Self-Awareness Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Robert J DeRubeis, PhD

  University of Pennsylvania

  STUDY DIRECTOR

• Akash Wasil

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akash Wasil

CONTACT

6317669466; akashwasil133@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: January 31, 2021
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)