Depressive SymptomsNCT05138120
COMET India Follow-up Trial
A study testing Common Elements Toolbox in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania.
Trial summary
We are evaluating an online single-session intervention for mental health promotion among Indian college students. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Happiness
- What is being tested?
- Common Elements Toolbox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2021to 20 Nov 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- College Student
- Access to internet
- Proficient in English
Who cannot join
- -
About this study
Official title: Evaluating an Online Single-session Intervention (COMET) for Indian College Students
We are evaluating an online single-session intervention for mental health promotion among Indian college students.
- Conditions
- Depressive Symptoms, Anxiety, Happiness
- Being tested
- Common Elements Toolbox
- 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 ToolboxBehavioural
An unguided online single-session intervention with four modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion.
| Study group | Role | What they receive |
|---|---|---|
| Common Elements Toolbox | Experimental | Not described Receives: Behavioral: Common Elements Toolbox |
| Wait-list control | No intervention | Not described |
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 8 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 8 weeks post-intervention
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Measured: Up to 8 weeks post-intervention
Secondary outcomes (6)
Ratings on the 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
Ratings on the Intervention Appropriateness Measure (IAM)
Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.
Measured: Immediately after the intervention
Mechanisms of Change
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
Measured: Up to 8 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 indicate greater secondary control.
Measured: Up to 8 weeks post-intervention
Positive and Negative Affect Schedule
Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.
Measured: Up to 8 weeks post-intervention
Perceived Stress Scale-4
Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.
Measured: Up to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start20 Nov 2021 (estimated)
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Why it stopped: lack of enrollment
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138120
- Sponsor's protocol ID
- 849593
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Online Single-session Intervention (COMET) for Indian College Students
- ClinicalTrials.gov ID
- NCT05138120
- Acronym / sponsor ID
- 849593
- Conditions
- Depressive Symptoms, Anxiety, Happiness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Nov 2021 (estimated)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 30 Nov 2021 (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.
We are evaluating an online single-session intervention for mental health promotion among Indian college students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Elements Toolbox | Experimental | Behavioral: Common Elements Toolbox |
| Wait-list control | No intervention | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- College Student
- Access to internet
- Proficient in English
Key exclusion criteria (1 listed)
- -
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 ToolboxAn unguided online single-session intervention with four modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion. | Behavioural | Common Elements Toolbox |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Up to 8 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 8 weeks post-intervention
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time frame: Up to 8 weeks post-intervention
Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
6 secondary outcomes
Ratings on the Acceptability of Intervention Measure (AIM)
Time frame: Immediately after the intervention
Ratings on the Intervention Appropriateness Measure (IAM)
Time frame: Immediately after the intervention
Mechanisms of Change
Time frame: Up to 8 weeks post-intervention
Secondary Control
Time frame: Up to 8 weeks post-intervention
Positive and Negative Affect Schedule
Time frame: Up to 8 weeks post-intervention
Perceived Stress Scale-4
Time frame: Up to 8 weeks post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Toolbox in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 8 weeks post-intervention). The study lists 3 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 12 Jul 2023.