Evaluating an Online Wellness Intervention for Indian College Students

Anxiety Clinical Trial

Official title:

Online Wellness Activities for Indian College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592588
• Other study ID #: 843879
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: December 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Happiness

Intervention

Behavioral:
• Common Elements Toolbox
COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.
• Wait-list control
Participants in the control condition will receive access to the intervention after data collection for the study has been completed.

Locations

Country	Name	City	State
India	Ashoka University	New Delhi
India	Jindal Global University	Sonipat

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Ashoka University, Jindal Global University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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