Evaluating an Online Wellness Intervention for Indian College Students

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).

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Happiness
• Intervention / Treatment: Behavioral: Common Elements Toolbox; Behavioral: Wait-list control

• Study Type: Interventional
• Enrollment (Actual): 513
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India
    • Ashoka University
  • Sonipat, India
    • Jindal Global University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Ashoka University; Jindal Global University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 843879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No