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

Not Applicable

• Conditions: Depressive Symptoms; Anxiety
• Interventions: Other: Common Elements Toolbox- Adult version (COMET-A); Other: Self-awareness Control

• Registration Number: NCT04586192
• Lead Sponsor: University of Pennsylvania

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2021-01-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04
• Primary Completion: 2022-01-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COMET	Common Elements Toolbox- Adult version (COMET-A)	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).
Self-Awareness Control	Self-awareness Control	Participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.

Primary Outcome Measures

Name	Time	Method
Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)	Up to 12 weeks post-intervention	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)	Immediately after the intervention	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.
Change in Patient Health Questionnaire-9 (PHQ-9)	Up to 12 weeks post-intervention	Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)	Up to 12 weeks post-intervention	Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Mechanism Questions	Up to 12 weeks post-intervention	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	Up to 12 weeks post-intervention	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	Up to 12 weeks post-intervention	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	Immediately after the intervention	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States