COMET India Follow-up Trial

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05138120
Collaborator
(none)
1,000
2
24

Study Details

Study Description

Brief Summary

We are evaluating an online single-session intervention for mental health promotion among Indian college students.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Common Elements Toolbox
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluating an Online Single-session Intervention (COMET) for Indian College Students
Anticipated Study Start Date :
Nov 20, 2021
Anticipated Primary Completion Date :
Nov 20, 2022
Anticipated Study Completion Date :
Nov 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Common Elements Toolbox

Behavioral: Common Elements Toolbox
An unguided online single-session intervention with four modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion.

No Intervention: Wait-list control

Outcome Measures

Primary Outcome Measures

  1. Change in Patient Health Questionnaire-9 (PHQ-9) [Up to 8 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) [Up to 8 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) [Up to 8 weeks post-intervention]

    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) [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) [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 [Up to 8 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; If they will

  4. Secondary Control [Up to 8 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.

  5. Positive and Negative Affect Schedule [Up to 8 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.

  6. Perceived Stress Scale-4 [Up to 8 weeks post-intervention]

    Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • College Student

  • Access to internet

  • Proficient in English

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05138120
Other Study ID Numbers:
  • 849593
First Posted:
Nov 30, 2021
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2021