AssessmentNCT05896085
Game Based Assessment of Emotion-regulation Skills in College Students
A study testing REThink game in people with Assessment and Emotion Regulation, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The aim of this study will be to investigate the validity of the in-game performance measurements or scores as indicators of students'ER abilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assessment, Emotion Regulation
- What is being tested?
- REThink game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jul 2023to 29 Nov 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
- first year student at Babes-Bolyai University
- internet and PC access to complete the scales and game
Who cannot join
- no internet or PC access
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study will be to investigate the validity of the in-game performance measurements or scores as indicators of students'ER abilities.
- Conditions
- Assessment, Emotion Regulation
- Being tested
- REThink game
- Keywords
- online therapeutic game, emotion regulation, college students, mental health, game-based assessment
- Medical subject headings
- Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink gameOther
The Rethink therapeutic game is an online game developed based on Rational-Emotive Behavioral Therapy and has two versions: for children and adolescents and for adults. The Rethink therapeutic game for adults is available in 3D and VR version and consists of four levels, each of them training a specific emotion regulation ability such as: emotional awareness, mindfulness, cognitive change
| Study group | Role | What they receive |
|---|---|---|
| REThink game | Experimental | Participants will complete the online standardized scales and then complete the REThink therapeutic game's assessment system in 3D or VR version. Receives: Other: REThink game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health
The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg \&Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 "never" to 5 "everyday" where grater scores represents better mental health.
Measured: baseline, pre-intervention
Emotion regulation
The Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, \& Spinhoven, 2001) is a self-report scale measuring emotion regulation on a 5 point Likert scale ranging from "almost never" to "almost always". It had 9 subscales representing 9 emotion regulation strategies and grater scores represents grater involvement in using that strategy.
Measured: baseline, pre-intervention
Secondary outcomes (5)
MAAS
Brown, K. W., \& Ryan, R. M. (2003). Mindful attention awareness scale. Journal of personality and social psychology The Mindfull Attention Awareness Scale is a 15 items self-report scale, rated on 5 point Likert scale from "almost never" to "almost always", where greater scores represents better mindfulness.
Measured: baseline, pre-intervention
Rational and irrational cognition
Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014) is a 24-items self-report scale that measures the presence of rational and irrational cognitions. It has two subscales one for rational cognitions and one for irrational cognitions. Greater scores at each scale represents more rational/irrational cognitions in an individual. Items are rated on a 5 point Liker scale ranging from "totally disagree" to "totally agree".
Measured: baseline, pre-intervention
Atention to positive and negative information
Attention to Positive and Negative Information Scale Noguchi, K., Gohm, C. L., \& Dalsky, D. J. (2006). Cognitive tendencies of focusing on positive and negative information. Journal of Research in Personality, 40(6), 891-910. It is a self- report scale for measuring the attention to positive or negative information. It is rated on a 5 point Likert scale ranging "not at all" to " completely conform"and it has 29 items. Grater scores at this scale represent more attantion toward a specific type of information-negative or positive.
Measured: baseline, pre-intervention
emotional distress
Distress and positive emotions: Profile of Affective Distress Plus; PED Opris \& Macavei, 2007 is a self-report scale that measure distress. It had 42 items rated on a 5 point Liker scale ranging from "not al all" to "a lot" and grater scores represent grated level of distress.
Measured: baseline, pre-intervention
emotional awareness
The Emotion Awareness Questionnaire (EAQ, Rieffe et al., 2008) is a 32-item questionnaire on a three-point Liker scale, from 0 "not true" to 2 "certainly true" where greater scores represents better levels of emotional awareness.
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jul 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AssessmentStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 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
- NCT05896085
- Sponsor's protocol ID
- REThin Academy - assessment
- Status last verified
- Dec 2023
- First submitted
- 26 May 2023
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game Based Assessment of Emotion-regulation Skills in College Students
- ClinicalTrials.gov ID
- NCT05896085
- Acronym / sponsor ID
- REThin Academy - assessment
- Conditions
- Assessment, Emotion Regulation
- Keywords
- online therapeutic game, emotion regulation, college students, mental health, game-based assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 9 Jun 2023 (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 aim of this study will be to investigate the validity of the in-game performance measurements or scores as indicators of students'ER abilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REThink game | Experimental | Other: REThink gameParticipants will complete the online standardized scales and then complete the REThink therapeutic game's assessment system in 3D or VR version. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first year student at Babes-Bolyai University
- internet and PC access to complete the scales and game
Key exclusion criteria (1 listed)
- no internet or PC access
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 |
|---|---|---|
| REThink gameThe Rethink therapeutic game is an online game developed based on Rational-Emotive Behavioral Therapy and has two versions: for children and adolescents and for adults. The Rethink therapeutic game for adults is available in 3D and VR version and consists of four levels, each of them training a specific emotion regulation ability such as: emotional awareness, mindfulness, cognitive change | Other | REThink game |
Primary outcome
Mental Health
Time frame: baseline, pre-intervention
The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg \&Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 "never" to 5 "everyday" where grater scores represents better mental health.
Emotion regulation
Time frame: baseline, pre-intervention
The Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, \& Spinhoven, 2001) is a self-report scale measuring emotion regulation on a 5 point Likert scale ranging from "almost never" to "almost always". It had 9 subscales representing 9 emotion regulation strategies and grater scores represents grater involvement in using that strategy.
5 secondary outcomes
MAAS
Time frame: baseline, pre-intervention
Rational and irrational cognition
Time frame: baseline, pre-intervention
Atention to positive and negative information
Time frame: baseline, pre-intervention
emotional distress
Time frame: baseline, pre-intervention
emotional awareness
Time frame: baseline, pre-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 6 Dec 2023.
- Individual participant dataSharing planned: No
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THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
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 REThink game in people with Assessment and Emotion Regulation, 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 2 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 6 Dec 2023. 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?
Mental Health (time frame: baseline, pre-intervention). The study lists 2 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 6 Dec 2023.