COMET India Follow-up Trial

Anxiety Clinical Trial

Official title:

Evaluating an Online Single-session Intervention (COMET) for Indian College Students

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05138120
• Other study ID #: 849593
• Status: Withdrawn
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: November 20, 2022

Study information

• Verified date: November 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• College Student

• Access to internet

• Proficient in English

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Happiness

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

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 8 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 8 weeks post-intervention
Primary	Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)	Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.	Up to 8 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; If they will	Up to 8 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 8 weeks post-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 8 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 8 weeks post-intervention