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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
513
COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.
Participants in the control condition will receive access to the intervention after data collection for the study has been completed.
Ashoka University
New Delhi, India
Jindal Global University
Sonīpat, India
Change in Patient Health Questionnaire-9 (PHQ-9)
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks post-intervention
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks post-intervention
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