NCT05653908

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

November 29, 2022

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (15)

  • Rational and irrational beliefs

    Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)

    baseline, pre-intervention

  • Changes in rational and irrational beliefs

    Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)

    immediately after the intervention

  • Fluctuation in rational and irrational beliefs

    Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)

    during the intervention

  • Mental Health

    Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)

    baseline, pre-intervention

  • Changes in Mental Health

    Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)

    immediately after the intervention

  • Fluctuation in Mental Health

    Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)

    during the intervention

  • Mood disorders

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (3)

  • Trauma

    baseline, pre-intervention

  • Loneliness

    baseline, pre-intervention

  • Fluctuation in loneliness

    during the intervention

Study Arms (1)

Daily monitoring

EXPERIMENTAL
Other: StudentMood

Interventions

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

Daily monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • student in Babes-Bolyai University in the first year

You may not qualify if:

  • incapacity of accessing the mobile app

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ph.D of Clinical Psychology

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 16, 2022

Study Start

October 20, 2022

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

November 1, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations