Mental Health IssueNCT05653908
REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age
A study testing StudentMood in people with Mental Health Issue, run by Babes-Bolyai University at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- StudentMood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteRomania
- Study dates
- 20 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- student in Babes-Bolyai University in the first year
Who cannot join
- incapacity of accessing the mobile app
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mental Health Issue
- Being tested
- StudentMood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StudentMoodOther
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
| Study group | Role | What they receive |
|---|---|---|
| Daily monitoring | Experimental | Not described Receives: Other: StudentMood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rational and irrational beliefs
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
Measured: baseline, pre-intervention
Changes in rational and irrational beliefs
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
Measured: immediately after the intervention
Fluctuation in rational and irrational beliefs
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
Measured: during the intervention
Mental Health
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)
Measured: baseline, pre-intervention
Changes in Mental Health
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)
Measured: immediately after the intervention
Fluctuation in Mental Health
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)
Measured: during the intervention
Mood disorders
DASS Parkitny, L., \& McAuley, J. (2010). The depression anxiety stress scale (DASS). Journal of physiotherapy, 56(3), 204.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: during the intervention
Secondary outcomes (3)
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
Measured: baseline, pre-intervention
Loneliness
Snape, D., \& Martin, G. (2018). Measuring loneliness: guidance for use of the National indicators on surveys. Office for National Statistics.
Measured: baseline, pre-intervention
Fluctuation in loneliness
Snape, D., \& Martin, G. (2018). Measuring loneliness: guidance for use of the National indicators on surveys. Office for National Statistics.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Oct 2022
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653908
- Sponsor's protocol ID
- REThin Academy
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2022
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age
- ClinicalTrials.gov ID
- NCT05653908
- Acronym / sponsor ID
- REThin Academy
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily monitoring | Experimental | Other: StudentMood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- student in Babes-Bolyai University in the first year
Key exclusion criteria (1 listed)
- incapacity of accessing the mobile app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StudentMoodStudentMood 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 | Other | Daily monitoring |
Primary outcome
Rational and irrational beliefs
Time frame: baseline, pre-intervention
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014)
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)
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)
Mental Health
Time frame: baseline, pre-intervention
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)
Changes in Mental Health
Time frame: immediately after the intervention
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)
Fluctuation in Mental Health
Time frame: during the intervention
Mental health- The General Health Questionnaire, 12-item version (GHQ-12)(Goldberg \&Williams, 1988)
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.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Trauma
Time frame: baseline, pre-intervention
Loneliness
Time frame: baseline, pre-intervention
Fluctuation in loneliness
Time frame: during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StudentMood in people with Mental Health Issue, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rational and irrational beliefs (time frame: baseline, pre-intervention). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.