Evaluating an Online Wellness Intervention for Indian College Students

Not Applicable

Completed

• Conditions: Happiness; Anxiety; Depressive Symptoms
• Interventions: Behavioral: Common Elements Toolbox; Behavioral: Wait-list control

• Registration Number: NCT04592588
• Lead Sponsor: University of Pennsylvania

Brief 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.

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-12
• Study Start: 2020-10-19
• Study First Posted: 2020-10-19
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

At least 18 years old and a student at a participating university in India.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common Elements Toolbox (COMET)	Common Elements Toolbox	The Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems.
Wait-list control condition	Wait-list control	-

Primary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)	Up to 12 weeks post-intervention	Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Change in Patient Health Questionnaire-9 (PHQ-9)	Up to 12 weeks post-intervention	Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)	Up to 12 weeks post-intervention	Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.

Secondary Outcome Measures

Name	Time	Method
Perceived Utility	Immediately after the intervention	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.
The Social Connectedness Scale	Up to 12 weeks post-intervention	Questionnaire measuring social connectedness. Scores range from 8 to 48, with higher scores indicating greater social connectedness.
Ratings on the Acceptability of Intervention Measure (AIM)	Immediately after the intervention	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.
Ratings on the Intervention Appropriateness Measure (IAM)	Immediately after the intervention	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.
Mechanisms of Change	Up to 12 weeks post-intervention	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
Secondary Control	Up to 12 weeks post-intervention	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.
Ability to Cope with COVID-19	Up to 12 weeks post-intervention	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.
Positive and Negative Affect Schedule	Up to 12 weeks post-intervention	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
Perceived Stress Scale-4	Up to 12 weeks post-intervention	Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.

Trial Locations

Locations (2)

Jindal Global University; 🇮🇳 Sonipat, India

Ashoka University; 🇮🇳 New Delhi, India