COMET India Follow-up Trial

Not Applicable

Withdrawn

• Conditions: Anxiety; Depressive Symptoms; Happiness
• Interventions: Behavioral: Common Elements Toolbox

• Registration Number: NCT05138120
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study Start: 2021-11-20
• Study First Posted: 2021-11-30
• Primary Completion: 2022-11-20
• Study Completion: 2022-11-20
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• College Student
• Access to internet
• Proficient in English

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common Elements Toolbox	Common Elements Toolbox	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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
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.
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.