Evaluating an Online Wellness Intervention for Indian College Students

NCT04592588 | Completed

• 1 other identifier: 843879
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 2

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).

Conditions

Depressive Symptoms; Anxiety; Happiness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Ratings on the Acceptability of Intervention Measure (AIM)

  Immediately after the intervention

• Ratings on the Intervention Appropriateness Measure (IAM)

  Immediately after the intervention

• Mechanisms of Change

  Up to 12 weeks post-intervention

• Ability to Cope with COVID-19

  Up to 12 weeks post-intervention

• Secondary Control

  Up to 12 weeks post-intervention

Study Arms (2)

Common Elements Toolbox (COMET)

EXPERIMENTAL

The Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems.

Behavioral: Common Elements Toolbox

Wait-list control condition

SHAM COMPARATOR

Behavioral: Wait-list control

Interventions

Common Elements Toolbox BEHAVIORAL

COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.

Common Elements Toolbox (COMET)

Wait-list control BEHAVIORAL

Participants in the control condition will receive access to the intervention after data collection for the study has been completed.

Wait-list control condition

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Pennsylvania: lead
• Ashoka University: collaborator
• Jindal Global University: collaborator

Study Sites (2)

Ashoka University

New Delhi, India

Location

Jindal Global University

Sonīpat, India

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: October 19, 2020
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)