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| Name | Class |
|---|---|
| Ashoka University | UNKNOWN |
| Jindal Global University | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wait-list control condition | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Common Elements Toolbox | Behavioral | COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) | Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression. | 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. | 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. | Up to 12 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the intervention |
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Inclusion Criteria: At least 18 years old and a student at a participating university in India.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashoka University | New Delhi | India | ||||
| Jindal Global University |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Wait-list control | Behavioral | Participants in the control condition will receive access to the intervention after data collection for the study has been completed. |
|
| 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. |
| 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 | 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. | 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. | 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. | 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 | 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. | 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. | Up to 12 weeks post-intervention |
| Sonīpat |
| India |