Evaluating an Online Wellness Intervention for Indian College Students

Study Overview
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Brief Summary
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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).

Official Title
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Online Wellness Activities for Indian College Students

Conditions
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Depressive Symptoms, Anxiety, Happiness

Intervention / Treatment
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* Behavioral: Common Elements Toolbox
* Behavioral: Wait-list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old and a student at a participating university in India.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Common Elements Toolbox (COMET)<br>The Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems. | Behavioral: Common Elements Toolbox<br>* COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.<br>|
| Sham Comparator: Wait-list control condition<br> | Behavioral: Wait-list control<br>* Participants in the control condition will receive access to the intervention after data collection for the study has been completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |