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

Anxiety Clinical Trial

— COMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586192
• Other study ID #: 30845924
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: University of Pennsylvania
• Contact: Akash Wasil
• Phone: 6317669466
• Email: akashwasil133[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older
• Eligibility: Adult participants (at least 18 years old) will be eligible for this study.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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