- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07357363
REThink for Mental Health of Youths in Romania
January 15, 2026 updated by: Oana David, Babes-Bolyai University
REThink for Mental Health of the Youths in Romania
In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group.
A minimum of 1000 students from the participating institutions (schools will be able to join based on a recruitment call), will be recruited and randomly assigned to either the experimental or control group.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oana David
- Phone Number: +40-264-434141
- Email: oanadavid@psychology.ro
Study Locations
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Cluj-Napoca, Romania
- Babes-Bolyai University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- internet and PC access to complete the scales and game
Exclusion Criteria:
- no internet of PC access
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: REThink
To ensure age-appropriate interventions, students below the age of 18 in the experimental group will receive the REThink game, while college-aged participants will engage with the REThink LIFE game.
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At its core, the REThink game consists of seven levels, each focusing on a specific emotion-regulation skill crucial for emotional health.
The game's story is based on the RETMAN character which helps the player fight the power of the "Irrationalizer" who personalizes irrational beliefs.
The game is based on cognitive-behavioral psychotherapy - the unified protocol (Barlow et al., 2004) and well-supported Rational Emotive Behavioral Therapy (Ellis, 1995).
Each level is composed of three sublevels, increasing in difficulty, and also has an embedded validated assessment system (composed of a sublevel for each level; David, Tomoiaga & Fodor, 2024), and can function as a standalone intervention.
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No Intervention: Control
The students randomized in the control group will access the intervention after finalizing the post-test measurement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bullying
Time Frame: baseline assessment, one week before starting the intervention
|
Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying.
The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying
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baseline assessment, one week before starting the intervention
|
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Compassion
Time Frame: baseline assessment, one week before starting the intervention
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Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.
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baseline assessment, one week before starting the intervention
|
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Trauma Screening
Time Frame: baseline assessment, one week before starting the intervention
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Childhood Trauma Screener is used to measure past traumatic experiences .The scale is composed of 5 items each representing a type of trauma or abuse.
Higher scores represent higher frequency of abuse and/or trauma.
The minimum score is and the maximum score is 5 and the maximum 25.
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baseline assessment, one week before starting the intervention
|
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Mental Health
Time Frame: baseline assessment
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Depression, Anxiety, and Stress Scale is used for mental healh.
For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.
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baseline assessment
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Mental Health Stigma
Time Frame: baseline assessment
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Peer Mental Health Stigmatization Scale measures mental health stigma.
Lower scores represent an improvement.
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baseline assessment
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Stress
Time Frame: baseline assessment
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MoodWheel instrument is used to measure stress.
The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions.
Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160.
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baseline assessment
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Self Compassion
Time Frame: baseline assessment
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The Self-Compassion Scale Short Form is used to measure self-compassion.
The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.
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baseline assessment
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Emotion Regulation
Time Frame: baseline assessment, one week before starting the intervention
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The in-game assessment for each REThink intervention.
This assessment system is the trial version of the game with sections for each level and very good psychometric properties.
For this system, higher scores represent higher levels of various emotion-regulation abilities.
|
baseline assessment, one week before starting the intervention
|
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Changes in Bullying
Time Frame: post-test assessment, one week after finishing the intervention
|
Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying.
The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying
|
post-test assessment, one week after finishing the intervention
|
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Changes in Mental Health
Time Frame: post-test assessment, one week after finishing the intervention
|
Depression, Anxiety, and Stress Scale is used for mental healh.
For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.
|
post-test assessment, one week after finishing the intervention
|
|
Changes in Mental Health Stigma
Time Frame: post-test assessment, one week after finishing the intervention
|
The Peer Mental Health Stigmatization Scale measures mental health stigma.
Lower scores represent an improvement.
|
post-test assessment, one week after finishing the intervention
|
|
Changes in Stress
Time Frame: post-test assessment, one week after finishing the intervention
|
MoodWheel instrumentis used to measure stress.
The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions.
Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160
|
post-test assessment, one week after finishing the intervention
|
|
Changes in Self-Compassion
Time Frame: post-test assessment, one week after finishing the intervention
|
The Self-Compassion Scale Short Form is used to measure self-compassion.
The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.
|
post-test assessment, one week after finishing the intervention
|
|
Changes in Compassion
Time Frame: post-test assessment, one week after finishing the intervention
|
Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.
|
post-test assessment, one week after finishing the intervention
|
|
Changes in Emotion Regulation
Time Frame: post-test assessment, one week after finishing the intervention
|
The in-game assessment for each REThink intervention.
This assessment system is the trial version of the game with sections for each level and very good psychometric properties.
For this system, higher scores represent higher levels of various emotion-regulation abilities.
|
post-test assessment, one week after finishing the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
January 15, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- REThinkBullying Being
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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