REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age

Mental Health Issue Clinical Trial

Official title:

REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653908
• Other study ID #: REThin Academy
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• student in Babes-Bolyai University in the first year

Exclusion Criteria:

• incapacity of accessing the mobile app

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Other:
• StudentMood
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

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Babes-Bolyai University	The Executive Agency for Higher Education, Research, Development and Innovation Funding

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rational and irrational beliefs	Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)	baseline, pre-intervention
Primary	Changes in rational and irrational beliefs	Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)	immediately after the intervention
Primary	Fluctuation in rational and irrational beliefs	Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)	during the intervention
Primary	Mental Health	Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg &Williams, 1988)	baseline, pre-intervention
Primary	Changes in Mental Health	Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg &Williams, 1988)	immediately after the intervention
Primary	Fluctuation in Mental Health	Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg &Williams, 1988)	during the intervention
Primary	Distress	Distress and positive emotions: Profile of Affective Distress Plus; PED Opris & Macavei, 2007	baseline, pre-intervention
Primary	Changes in distress	Distress and positive emotions: Profile of Affective Distress Plus; PED Opris & Macavei, 2007	immediately after the intervention
Primary	Stress	Perceived Stress Scale Cohen, S., Kamarck, T., & Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 385-396.	baseline, pre-intervention
Primary	Changes in stress	Perceived Stress Scale Cohen, S., Kamarck, T., & Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 385-396.	immediately after the intervention
Primary	Fluctuation in stress	Perceived Stress Scale Cohen, S., Kamarck, T., & Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 385-396.	during the intervention
Primary	Well-being	WHO -5 Topp, C. W., Østergaard, S. D., Søndergaard, S., & Bech, P. (2015). The WHO-5 Well-Being Index: a systematic review of the literature. Psychotherapy and psychosomatics, 84(3), 167-176.	baseline, pre-intervention
Primary	Changes in well-being	WHO -5 Topp, C. W., Østergaard, S. D., Søndergaard, S., & Bech, P. (2015). The WHO-5 Well-Being Index: a systematic review of the literature. Psychotherapy and psychosomatics, 84(3), 167-176.	immediately after the intervention
Primary	Fluctuation in well-being	WHO -5 Topp, C. W., Østergaard, S. D., Søndergaard, S., & Bech, P. (2015). The WHO-5 Well-Being Index: a systematic review of the literature. Psychotherapy and psychosomatics, 84(3), 167-176.	during the intervention
Primary	Self-Compassion	Self-Compassion Scale - Short Form Raes, F., Pommier, E., Neff, K. D., & Van Gucht, D. (2011). Construction and factorial validation of a short form of the self-compassion scale. Clinical psychology & psychotherapy, 18(3), 250-255.	baseline, pre-intervention
Primary	Changes in self-Compassion	Self-Compassion Scale - Short Form Raes, F., Pommier, E., Neff, K. D., & Van Gucht, D. (2011). Construction and factorial validation of a short form of the self-compassion scale. Clinical psychology & psychotherapy, 18(3), 250-255.	immediately after the intervention
Primary	Emotion regulation	Gross and John (2003) Emotion Regulation Questionnaire (ERQ),	baseline, pre-intervention
Primary	Changes in emotion regulation	Gross and John (2003) Emotion Regulation Questionnaire (ERQ),	immediately after the intervention
Primary	Insomnia	Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep medicine, 2(4), 297-307.	baseline, pre-intervention
Primary	Changes in insomnia	Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep medicine, 2(4), 297-307.	immediately after the intervention
Primary	Fluctuation in insomnia	Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep medicine, 2(4), 297-307.	during the intervention
Primary	Suicide	Osman, A., Bagge, C. L., Gutierrez, P. M., Konick, L. C., Kopper, B. A., & Barrios, F. X. (2001). The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment, 8(4), 443-454.	baseline, pre-intervention
Primary	Changes in suicide	Osman, A., Bagge, C. L., Gutierrez, P. M., Konick, L. C., Kopper, B. A., & Barrios, F. X. (2001). The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment, 8(4), 443-454.	immediately after the intervention
Primary	Fluctuation in suicide	Osman, A., Bagge, C. L., Gutierrez, P. M., Konick, L. C., Kopper, B. A., & Barrios, F. X. (2001). The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment, 8(4), 443-454.	during the intervention
Primary	Mood disorders	DASS Parkitny, L., & McAuley, J. (2010). The depression anxiety stress scale (DASS). Journal of physiotherapy, 56(3), 204.	baseline, pre-intervention
Primary	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)
Primary	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
Primary	Somatic sympthoms	Gierk, B., Kohlmann, S., Kroenke, K., Spangenberg, L., Zenger, M., Brähler, E., & Löwe, B. (2014). The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden. JAMA internal medicine, 174(3), 399-407.	baseline, pre-intervention
Primary	Changes in somatic sympthoms	Gierk, B., Kohlmann, S., Kroenke, K., Spangenberg, L., Zenger, M., Brähler, E., & Löwe, B. (2014). The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden. JAMA internal medicine, 174(3), 399-407.	immediately after the intervention
Primary	Fluctuation in somatic sympthoms	Gierk, B., Kohlmann, S., Kroenke, K., Spangenberg, L., Zenger, M., Brähler, E., & Löwe, B. (2014). The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden. JAMA internal medicine, 174(3), 399-407.	during the intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	College Student Adjustment	Watson, J. C., & Lenz, A. S. (2020). Development and evaluation of the inventory of new college student adjustment. Journal of College Student Retention: Research, Theory & Practice, 22(3), 425-440.	during the intervention
Primary	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	Personality	Big 5 Rammstedt, B. & John, O. P. (2007). Measuring personality in one minute or less: A 10 item short version of the Big Five Inventory in English and German. Journal of Research in Personality, 41, 203-212.	baseline, pre-intervention
Secondary	Attachment	Wongpakaran N, DeMaranville J, Wongpakaran T. Validation of the Relationships Questionnaire (RQ) against the Experience of Close Relationship-Revised Questionnaire in a Clinical Psychiatric Sample. Healthcare (Basel). 2021 Sep 7;9(9):1174. doi: 10.3390/healthcare9091174. PMID: 34574948; PMCID: PMC8470855.	baseline, pre-intervention
Secondary	Trauma	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
Secondary	Schemas	Young Schema Questionnaire - one subscale Young, J. E., & Brown, G. (2005). Young schema questionnaire-short form; Version 3. Psychological Assessment.	immediately after the intervention
Secondary	Loneliness	Snape, D., & Martin, G. (2018). Measuring loneliness: guidance for use of the National indicators on surveys. Office for National Statistics.	baseline, pre-intervention
Secondary	Fluctuation in loneliness	Snape, D., & Martin, G. (2018). Measuring loneliness: guidance for use of the National indicators on surveys. Office for National Statistics.	during the intervention
Secondary	Coping strategies	B-COpe Carver, Scheier & Weintraub, 1989	baseline, pre-intervention
Secondary	Fluctuation in coping strategies	B-COpe Carver, Scheier & Weintraub, 1989	during the intervention
Secondary	Senzitivity to reward	Sava, F. A., & Sperneac, A. M. (2006). Sensitivity to reward and sensitivity to punishment rating scales: A validation study on the Romanian population. Personality and Individual differences, 41(8), 1445-1456.	baseline, pre-intervention
Secondary	Changes to sensitivity to reward	Sava, F. A., & Sperneac, A. M. (2006). Sensitivity to reward and sensitivity to punishment rating scales: A validation study on the Romanian population. Personality and Individual differences, 41(8), 1445-1456.	immediately after the intervention
Secondary	Changes in Attitudes toward self	Carver, C. S., & Ganellen, R. J. (1983). Depression and components of self-punitiveness: high standards, self-criticism, and overgeneralization. Journal of abnormal Psychology, 92(3), 330.	immediately after the intervention
Secondary	attitudes toward self	Carver, C. S., & Ganellen, R. J. (1983). Depression and components of self-punitiveness: high standards, self-criticism, and overgeneralization. Journal of abnormal Psychology, 92(3), 330.	baseline, pre-intervention
Secondary	Positive overgeneralization	Eisner, L. R., Johnson, S. L., & Carver, C. S. (2008). Cognitive responses to failure and success relate uniquely to bipolar depression versus mania. Journal of Abnormal Psychology, 117(1), 154.	baseline, pre-intervention
Secondary	Changes in positive overgeneralization	Eisner, L. R., Johnson, S. L., & Carver, C. S. (2008). Cognitive responses to failure and success relate uniquely to bipolar depression versus mania. Journal of Abnormal Psychology, 117(1), 154.	immediately after the intervention
Secondary	PERMA	Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3).	baseline, pre-intervention
Secondary	Changes in PERMA	Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3).	baseline, pre-intervention
Secondary	Fluctuations in PERMA	Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3).	during the intervention