Depressive SymptomsNCT04592588
Evaluating an Online Wellness Intervention for Indian College Students
A study testing Common Elements Toolbox in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 2 sites in India.
Trial summary
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition. 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?
- Yes, some participants may receive a placebo
- How many people
- 513 participants
- Where
- 2 sitesIndia
- Study dates
- 19 Oct 2020to 30 Dec 2021
- 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
Inclusion Criteria: At least 18 years old and a student at a participating university in India.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Online Wellness Activities for Indian College Students
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition.
Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being) will be measures at two weeks post-intervention, four weeks post-intervention, and twelve weeks post-intervention.
We will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).
- Conditions
- Depressive Symptoms, Anxiety, Happiness
- Being tested
- Common Elements Toolbox, Wait-list 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 ToolboxBehavioural
COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.
Wait-list controlBehavioural
Participants in the control condition will receive access to the intervention after data collection for the study has been completed.
| Study group | Role | What they receive |
|---|---|---|
| Common Elements Toolbox (COMET) | Experimental | The Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems. Receives: Behavioral: Common Elements Toolbox |
| Wait-list control condition | Sham comparator | Not described Receives: Behavioral: Wait-list control |
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 the 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
Secondary outcomes (9)
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
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 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 indicate greater perceived utility.
Measured: Immediately after the 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 12 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 12 weeks post-intervention
The Social Connectedness Scale
Questionnaire measuring social connectedness. Scores range from 8 to 48, with higher scores indicating greater social connectedness.
Measured: Up to 12 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 posted19 Oct 2020
- Study start19 Oct 2020
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Ashoka University, Jindal Global University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592588
- Sponsor's protocol ID
- 843879
- Status last verified
- Jul 2023
- First submitted
- 12 Oct 2020
- Last updated
- 11 Jul 2023
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Wellness Activities for Indian College Students
- ClinicalTrials.gov ID
- NCT04592588
- Acronym / sponsor ID
- 843879
- Conditions
- Depressive Symptoms, Anxiety, Happiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Ashoka University, Jindal Global University
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 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.
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition.
Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being) will be measures at two weeks post-intervention, four weeks post-intervention, and twelve weeks post-intervention.
We will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Elements Toolbox (COMET) | Experimental | Behavioral: Common Elements ToolboxThe Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems. |
| Wait-list control condition | Sham comparator | Behavioral: Wait-list control |
Who may qualify
- Ages
- 18 to 99 years
- 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 ToolboxCOMET is an online unguided self-help intervention that lasts approximately 45-60 minutes. | Behavioural | Common Elements Toolbox (COMET) |
| Wait-list controlParticipants in the control condition will receive access to the intervention after data collection for the study has been completed. | Behavioural | Wait-list control condition |
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 the 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.
9 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 12 weeks post-intervention
Ability to Cope with COVID-19
Time frame: Up to 12 weeks post-intervention
Secondary Control
Time frame: Up to 12 weeks post-intervention
Perceived Utility
Time frame: Immediately after the intervention
Positive and Negative Affect Schedule
Time frame: Up to 12 weeks post-intervention
Perceived Stress Scale-4
Time frame: Up to 12 weeks post-intervention
The Social Connectedness Scale
Time frame: Up to 12 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 2 sites in India.
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: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 12 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 11 Jul 2023.