Online Wellness Intervention for College Students

NCT04740411 | Unknown

• 1 other identifier: 844589
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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 college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.

Conditions

Depression; Anxiety; Well-being

Outcome Measures

Primary Outcomes (4)

• Change in the Patient Health Questionnaire-9 (PHQ-9)

  Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.

  Up to 8 weeks post-intervention

• Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)

  Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.

  Up to 8 weeks post-intervention

• Change in the Short Warwick-Edinburgh Mental Well-being Scale

  Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.

  Up to 8 weeks post-intervention

• Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).

  Well-being questionnaire with questions related to positive emotion, engagement, relationships, meaning, accomplishment, negative emotion, and health. Scores on each item range from 0 to 5. Lower scores indicate less well-being. We are using a shortened version of this questionnaire with 12 items. We have also modified the items to ask participants about their experiences over the past 48 hours. We predict that our intervention will produce changes in the positive emotion and negative emotion subscales. Each subscale consists of 3 items.

  Up to 8 weeks post-intervention

Secondary Outcomes (12)

• Ratings on the Acceptability of Intervention Measure (AIM)

  Immediately after the intervention

• Ability to Cope with COVID-19

  Up to 8 weeks post-intervention

• Change in Secondary Control

  Up to 8 weeks post-intervention

• Change in the Positive and Negative Affect Schedule

  Up to 8 weeks post-intervention

• Perceived Utility Ratings

  Immediately after the intervention

Study Arms (2)

Common Elements Toolbox (COMET)

EXPERIMENTAL

Behavioral: The Common Elements Toolbox (COMET)

Wait-list control condition

NO INTERVENTION

Interventions

The Common Elements Toolbox (COMET) BEHAVIORAL

COMET is an online unguided self-help intervention that lasts approximately 60-80 minutes.

Common Elements Toolbox (COMET)

Eligibility Criteria

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

You may qualify if:

• At least 18 years old and a student at a participating university. Access to the internet.

You may not qualify if:

• Cannot have participated in a previous version of COMET.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Indiana University: collaborator
• Ohio State University: collaborator
• University of Missouri, St. Louis: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Akash Wasil, MA

CONTACT

631-766-9466; wasil@sas.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

US (1)