NCT07357363

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (15)

  • Bullying

    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

    baseline assessment, one week before starting the intervention

  • Mental Health

    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.

    baseline assessment

  • Mental Health Stigma

    Peer Mental Health Stigmatization Scale measures mental health stigma. Lower scores represent an improvement.

    baseline assessment

  • Stress

    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.

    baseline assessment

  • Self Compassion

    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.

    baseline assessment

  • Compassion

    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.

    baseline assessment, one week before starting the intervention

  • Emotion Regulation

    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

  • Trauma Screening

    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.

    baseline assessment, one week before starting the intervention

  • Changes in Bullying

    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

  • Changes in Mental Health

    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

    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

    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

    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

    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

    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

Study Arms (2)

Experimental: REThink

EXPERIMENTAL

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.

Behavioral: REThink Intervention

Control

NO INTERVENTION

The students randomized in the control group will access the intervention after finalizing the post-test measurement

Interventions

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.

Experimental: REThink

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • internet and PC access to complete the scales and game

You may not qualify if:

  • no internet of PC access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ph.D of Clinical Psychology

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 22, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations