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NCT Number: NCT07357363

REThink for Mental Health of 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.

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Key information

Conditions

Bullying Victimisation Bullying Behavior Bullying of Child

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Romania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • internet and PC access to complete the scales and game

Exclusion criteria

  • no internet of PC access

Treatment and study plan

REThink Intervention

Behavioral

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.

Primary outcomes

  1. 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

  2. Mental Health

    Time frame: baseline assessment

    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.

  3. Mental Health Stigma

    Time frame: baseline assessment

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

  4. Stress

    Time frame: baseline assessment

    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.

  5. Self Compassion

    Time frame: baseline assessment

    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.

  6. Compassion

    Time frame: baseline assessment, one week before starting 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.

  7. Emotion Regulation

    Time frame: baseline assessment, one week before starting 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.

  8. Trauma Screening

    Time frame: baseline assessment, one week before starting the intervention

    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.

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oana David

CONTACT

[email protected]

+40-264-434141

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

REThink for Mental Health of the Youths in Romania

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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