Evaluating an Online Wellness Intervention for Indian College Students

• ClinicalTrials.gov Identifier: NCT04592588
• Recruitment Status: Active, not recruiting
• First Posted: October 19, 2020
• Last Update Posted: October 4, 2021
• Sponsor: University of Pennsylvania
• Collaborators: Ashoka University; Jindal Global University
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Depressive Symptoms; Anxiety; Happiness	Behavioral: Common Elements Toolbox; Behavioral: Wait-list control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 513 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Online Wellness Activities for Indian College Students
• Actual Study Start Date: October 19, 2020
• Actual Primary Completion Date: August 30, 2021
• Estimated Study Completion Date: December 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Up to 12 weeks post-intervention ]
   Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
2. Change in Generalized Anxiety Disorder Screener-7 (GAD-7) [ Time Frame: Up to 12 weeks post-intervention ]
   Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
3. Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) [ Time Frame: 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 :

1. Ratings on the Acceptability of Intervention Measure (AIM) [ Time Frame: 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.
2. Ratings on the Intervention Appropriateness Measure (IAM) [ Time Frame: 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.
3. Mechanisms of Change [ Time Frame: 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

4. Ability to Cope with COVID-19 [ Time Frame: 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.

5. Secondary Control [ Time Frame: 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.

6. Perceived Utility [ Time Frame: 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.

7. Positive and Negative Affect Schedule [ Time Frame: 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
8. Perceived Stress Scale-4 [ Time Frame: Up to 12 weeks post-intervention ]
   Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.
9. The Social Connectedness Scale [ Time Frame: Up to 12 weeks post-intervention ]
   Questionnaire measuring social connectedness. Scores range from 8 to 48, with higher scores indicating greater social connectedness.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

India

Ashoka University

New Delhi, India

Jindal Global University

Sonipat, India

Sponsors and Collaborators

University of Pennsylvania

Ashoka University

Jindal Global University

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04592588
• Other Study ID Numbers: 843879
• First Posted: October 19, 2020
• Last Update Posted: October 4, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms