Depressive SymptomsCOMETNCT04586192
Digital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET
A study testing Common Elements Toolbox- Adult version (COMET-A) in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety
- What is being tested?
- Common Elements Toolbox- Adult version (COMET-A)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Adult participants (at least 18 years old) will be eligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Robert DeRubeis, PhD
About this study
Official title: Developing and Assessing a Digital Mental Health and Wellness Intervention for Adults: Randomized Control Trial of the Common Elements Toolbox (COMET)
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
- Being tested
- Common Elements Toolbox- Adult version (COMET-A), Self-awareness Control
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Self-awareness ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start31 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J DeRubeis, PhD, Study director, University of PennsylvaniaAkash Wasil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586192
- Sponsor's protocol ID
- 30845924
- Acronym
- COMET
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Assessing a Digital Mental Health and Wellness Intervention for Adults: Randomized Control Trial of the Common Elements Toolbox (COMET)
- ClinicalTrials.gov ID
- NCT04586192
- Acronym / sponsor ID
- COMET / 30845924
- Conditions
- Depressive Symptoms, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COMET | Experimental | Other: 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 | Sham comparator | Other: Self-awareness ControlParticipants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | COMET |
| Self-awareness ControlA control condition in which participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings. | Other | Self-Awareness Control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J DeRubeis, PhD study director
University of Pennsylvania
Akash Wasil principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Toolbox- Adult version (COMET-A) in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akash Wasil (6317669466, akashwasil133@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Up to 12 weeks post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.