Back to resultsDigital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET (COMET)
Primary Purpose
Depressive Symptoms, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Common Elements Toolbox- Adult version (COMET-A)
Self-awareness Control
Sponsored by
About this trial
This is an interventional supportive care trial for Depressive Symptoms
Eligibility Criteria
Adult participants (at least 18 years old) will be eligible for this study.
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
COMET
Self-Awareness Control
Waitlist
Arm 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).
Participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.
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.
Outcomes
Primary Outcome Measures
Change in Patient Health Questionnaire-9 (PHQ-9)
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
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.
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.
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
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04586192
First Posted
October 5, 2020
Last Updated
October 1, 2021
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04586192
Brief Title
Digital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET
Acronym
COMET
Official Title
Developing and Assessing a Digital Mental Health and Wellness Intervention for Adults: Randomized Control Trial of the Common Elements Toolbox (COMET)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COMET
Arm Type
Experimental
Arm 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).
Arm Title
Self-Awareness Control
Arm Type
Sham Comparator
Arm Description
Participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.
Arm Title
Waitlist
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Common Elements Toolbox- Adult version (COMET-A)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self-awareness Control
Intervention Description
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 Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Time Frame
Up to 12 weeks post-intervention
Title
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Description
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Time Frame
Up to 12 weeks post-intervention
Title
Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Description
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Time Frame
Up to 12 weeks post-intervention
Title
Ratings of Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
Immediately after the intervention
Title
Mechanism Questions
Description
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
Time Frame
Up to 12 weeks post-intervention
Title
Ability to Cope with COVID-19
Description
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.
Time Frame
Up to 12 weeks post-intervention
Title
Secondary Control
Description
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.
Time Frame
Up to 12 weeks post-intervention
Title
Perceived Utility
Description
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.
Time Frame
Immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Adult participants (at least 18 years old) will be eligible for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akash Wasil
Phone
6317669466
Email
akashwasil133@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J DeRubeis, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Akash Wasil
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert DeRubeis, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET
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