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

Sponsor
Babes-Bolyai University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05653908
Collaborator
The Executive Agency for Higher Education, Research, Development and Innovation Funding (Other)
500
1
1
7.4
67.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: StudentMood
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age
Actual Study Start Date :
Oct 20, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Daily monitoring

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

Outcome Measures

Primary Outcome Measures

  1. Rational and irrational beliefs [baseline, pre-intervention]

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

  2. Changes in rational and irrational beliefs [immediately after the intervention]

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

  3. Fluctuation in rational and irrational beliefs [during the intervention]

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

  4. Mental Health [baseline, pre-intervention]

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

  5. Changes in Mental Health [immediately after the intervention]

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

  6. Fluctuation in Mental Health [during the intervention]

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

  7. Distress [baseline, pre-intervention]

    Distress and positive emotions: Profile of Affective Distress Plus; PED Opris & Macavei, 2007

  8. Changes in distress [immediately after the intervention]

    Distress and positive emotions: Profile of Affective Distress Plus; PED Opris & Macavei, 2007

  9. Stress [baseline, pre-intervention]

    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.

  10. Changes in stress [immediately after the intervention]

    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.

  11. Fluctuation in stress [during the intervention]

    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.

  12. Well-being [baseline, pre-intervention]

    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.

  13. Changes in well-being [immediately after the intervention]

    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.

  14. Fluctuation in well-being [during the intervention]

    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.

  15. Self-Compassion [baseline, pre-intervention]

    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.

  16. Changes in self-Compassion [immediately after the intervention]

    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.

  17. Emotion regulation [baseline, pre-intervention]

    Gross and John (2003) Emotion Regulation Questionnaire (ERQ),

  18. Changes in emotion regulation [immediately after the intervention]

    Gross and John (2003) Emotion Regulation Questionnaire (ERQ),

  19. Insomnia [baseline, pre-intervention]

    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.

  20. Changes in insomnia [immediately after the intervention]

    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.

  21. Fluctuation in insomnia [during the intervention]

    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.

  22. Suicide [baseline, pre-intervention]

    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.

  23. Changes in suicide [immediately after the intervention]

    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.

  24. Fluctuation in suicide [during the intervention]

    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.

  25. Mood disorders [baseline, pre-intervention]

    DASS Parkitny, L., & McAuley, J. (2010). The depression anxiety stress scale (DASS). Journal of physiotherapy, 56(3), 204.

  26. Changes in mood disorders [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.

  27. Fluctuation in mood disorders [during the intervention]

    DASS Parkitny, L., & McAuley, J. (2010). The depression anxiety stress scale (DASS). Journal of physiotherapy, 56(3), 204.

  28. Somatic sympthoms [baseline, pre-intervention]

    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.

  29. Changes in somatic sympthoms [immediately after the intervention]

    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.

  30. Fluctuation in somatic sympthoms [during the intervention]

    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.

  31. Fluctuation in academic stress [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.

  32. Fluctuation in life experiences [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.

  33. Fluctuations in emotion regulation [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.

  34. Fluctuations in college student stress [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.

  35. Fluctuations in stress coping styles [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.

  36. College Student Adjustment [during the intervention]

    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.

  37. Student adaptation to college [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.

Secondary Outcome Measures

  1. Personality [baseline, pre-intervention]

    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.

  2. Attachment [baseline, pre-intervention]

    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.

  3. Trauma [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

  4. Schemas [immediately after the intervention]

    Young Schema Questionnaire - one subscale Young, J. E., & Brown, G. (2005). Young schema questionnaire-short form; Version 3. Psychological Assessment.

  5. Loneliness [baseline, pre-intervention]

    Snape, D., & Martin, G. (2018). Measuring loneliness: guidance for use of the National indicators on surveys. Office for National Statistics.

  6. Fluctuation in loneliness [during the intervention]

    Snape, D., & Martin, G. (2018). Measuring loneliness: guidance for use of the National indicators on surveys. Office for National Statistics.

  7. Coping strategies [baseline, pre-intervention]

    B-COpe Carver, Scheier & Weintraub, 1989

  8. Fluctuation in coping strategies [during the intervention]

    B-COpe Carver, Scheier & Weintraub, 1989

  9. Senzitivity to reward [baseline, pre-intervention]

    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.

  10. Changes to sensitivity to reward [immediately after the intervention]

    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.

  11. Changes in Attitudes toward self [immediately after the intervention]

    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.

  12. attitudes toward self [baseline, pre-intervention]

    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.

  13. Positive overgeneralization [baseline, pre-intervention]

    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.

  14. Changes in positive overgeneralization [immediately after the intervention]

    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.

  15. PERMA [baseline, pre-intervention]

    Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3).

  16. Changes in PERMA [baseline, pre-intervention]

    Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3).

  17. Fluctuations in PERMA [during the intervention]

    Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • student in Babes-Bolyai University in the first year
Exclusion Criteria:
  • incapacity of accessing the mobile app

Contacts and Locations

Locations

Site City State Country Postal Code
1 Babes-Bolyai University Cluj-Napoca Romania

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oana David, Professor Ph.D of Clinical Psychology, Babes-Bolyai University
ClinicalTrials.gov Identifier:
NCT05653908
Other Study ID Numbers:
  • REThin Academy
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 16, 2022