- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05653908
REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age
October 30, 2024 updated by: Oana David, Babes-Bolyai University
The project aims at monitoring mental health and its mechanism in the student population using a longitudinal design and ecological momentary assessment procedure throughout the first semester of college.
Study Overview
Study Type
Interventional
Enrollment (Actual)
550
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cluj-Napoca, Romania
- Babes-Bolyai University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- student in Babes-Bolyai University in the first year
Exclusion Criteria:
- incapacity of accessing the mobile app
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Daily monitoring
|
StudentMood is an app that uses ecological momentary assessment method to asses mood and other mental health corelates.
Participants will have to complete the application (the mood wheel, heart rate and other behavioral data as well as standardized scales) daily throughout the entire semester
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rational and irrational beliefs
Time Frame: baseline, pre-intervention
|
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
|
baseline, pre-intervention
|
|
Changes in rational and irrational beliefs
Time Frame: immediately after the intervention
|
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
|
immediately after the intervention
|
|
Fluctuation in rational and irrational beliefs
Time Frame: during the intervention
|
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
|
during the intervention
|
|
Mental Health
Time Frame: baseline, pre-intervention
|
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg &Williams, 1988)
|
baseline, pre-intervention
|
|
Changes in Mental Health
Time Frame: immediately after the intervention
|
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg &Williams, 1988)
|
immediately after the intervention
|
|
Fluctuation in Mental Health
Time Frame: during the intervention
|
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg &Williams, 1988)
|
during the intervention
|
|
Mood disorders
Time Frame: baseline, pre-intervention
|
DASS Parkitny, L., & McAuley, J. (2010).
The depression anxiety stress scale (DASS).
Journal of physiotherapy, 56(3), 204.
|
baseline, pre-intervention
|
|
Changes in mood disorders
Time Frame: Post-intervention (one week after the intervention)
|
DASS Parkitny, L., & McAuley, J. (2010).
The depression anxiety stress scale (DASS).
Journal of physiotherapy, 56(3), 204.
|
Post-intervention (one week after the intervention)
|
|
Fluctuation in mood disorders
Time Frame: during the intervention
|
DASS Parkitny, L., & McAuley, J. (2010).
The depression anxiety stress scale (DASS).
Journal of physiotherapy, 56(3), 204.
|
during the intervention
|
|
Fluctuation in academic stress
Time Frame: during the intervention
|
Lin, Y. M., & Chen, F. S. (2009).
Academic stress inventory of students at universities and colleges of technology.
World Transactions on Engineering and Technology Education, 7(2), 157-162.
|
during the intervention
|
|
Fluctuation in life experiences
Time Frame: during the intervention
|
Kohn, P. M., Lafreniere, K., & Gurevich, M. (1990).
The inventory of college students' recent life experiences: A decontaminated hassles scale for a special population.
Journal of behavioral medicine, 13(6), 619-630.
|
during the intervention
|
|
Fluctuations in emotion regulation
Time Frame: during the intervention
|
Garnefski, Nadia, and Vivian Kraaij.
"Cognitive emotion regulation questionnaire-development of a short 18-item version (CERQ-short)."
Personality and individual differences 41.6 (2006): 1045-1053.
|
during the intervention
|
|
Fluctuations in college student stress
Time Frame: during the intervention
|
Feldt, R. C. (2008).
Development of a brief measure of college stress: The college student stress scale.
Psychological reports, 102(3), 855-860.
|
during the intervention
|
|
Fluctuations in stress coping styles
Time Frame: during the intervention
|
Lin, Y. M., & Chen, F. S. (2010).
A stress coping style inventory of students at universities and colleges of technology.
World Transactions on Engineering and Technology Education, 8(1), 67-72.
|
during the intervention
|
|
Student adaptation to college
Time Frame: during the intervention
|
College Adaptation Questionaire is a scale ) to assess how well students have adjusted to university life, is a self-report instrument consisting of 18 statements.
Respondents indicate on a seven-point rating scale how well each statement applies Van Rooijen, L. (1986).
Advanced students' adaptation to college.
Higher Education, 15(3), 197-209.
|
during the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trauma
Time Frame: baseline, pre-intervention
|
Childhood Trauma Screener Witt, A., Öz, Y., Sachser, C. et al.
Validation and standardization of the Childhood Trauma Screener (CTS) in the general population.
Child Adolesc Psychiatry Ment Health 16, 73 (2022).
https://doi.org/10.1186/s13034-022-00506-6
|
baseline, pre-intervention
|
|
Loneliness
Time Frame: baseline, pre-intervention
|
Snape, D., & Martin, G. (2018).
Measuring loneliness: guidance for use of the National indicators on surveys.
Office for National Statistics.
|
baseline, pre-intervention
|
|
Fluctuation in loneliness
Time Frame: during the intervention
|
Snape, D., & Martin, G. (2018).
Measuring loneliness: guidance for use of the National indicators on surveys.
Office for National Statistics.
|
during the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2022
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
December 7, 2022
First Posted (Actual)
December 16, 2022
Study Record Updates
Last Update Posted (Estimated)
November 1, 2024
Last Update Submitted That Met QC Criteria
October 30, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- REThin Academy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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