Developing and Assessing a Digital Mental Health and Wellness Intervention for Adults: Randomized Control Trial of the Common Elements Toolbox (COMET)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Pennsylvania
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- Change in Patient Health Questionnaire-9 (PHQ-9)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult participants (at least 18 years old) will be eligible for this study.
Exclusion Criteria
- Not provided
Arms & Interventions
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).
Intervention: Common Elements Toolbox- Adult version (COMET-A) (Other)
Self-Awareness Control
Participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.
Intervention: Self-awareness Control (Other)
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.
Outcomes
Primary Outcomes
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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)
Time Frame: Up to 12 weeks post-intervention
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time Frame: 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)
Time Frame: 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.
Mechanism Questions
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported