Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study

This activity will have the objective of testing the validity of the integrated in-game assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders in youth.

Study Overview

• Status: Completed
• Conditions: Emotional Regulation
• Intervention / Treatment: Other: REThink Game; Other: MoodWheel; Other: PsyPills

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• children and adolescents between 8 and 16 years old
• provided written parental consent
• able to access mobile/internet applications on their device

Exclusion Criteria:

• Intellectual disability or physical limitations precluded the use of the computer program
• Had a major mental health disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REThink game; Each recruited participant randomized in the experimental group will receive the REThink game app.	Other: REThink Game; REThink Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of seven levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change, positive bias, distinction between useful and useless thoughts, problem solving and compassion.
Active Comparator: MoodWheel; The participants randomized in the control group will complete the MoodWheel app.	Other: MoodWheel; Mood Wheel is a web and mobile-based app that uses experience sampling procedures for the assessment of current/previous distress and positive emotions. The aim of the app is to inquire about the valence, control and functionality of users' emotions.
Experimental: PsyPills; Participants from experimental group who do not respond to REThink game alone will receive the PsyPills app	Other: REThink Game; REThink Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of seven levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change, positive bias, distinction between useful and useless thoughts, problem solving and compassion.; Other: PsyPills; PsyPills is a self-help psycho-educational instrument intended to build stress resilience and to target (only) mild and transient negative mood states, alone or in combination with other methods/instruments. Psychological Pills (PsyPills) are inspired by Rational-Emotive & Cognitive-Behavioral Therapy (CBT/REBT), which has strong evidence for its efficacy/effectiveness in human development/health promotion and in the treatment of a variety of psychological conditions. The PsyPills app was tested in a pilot study and showed positive effects on reducing distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of rational and irrational beliefs	The Child and Adolescent Scale of Irrationality will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")	baseline, pre-intervention
Fluctuations in of rational and irrational beliefs	The Child and Adolescent Scale of Irrationality will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")	6 months Follow-up
Levels of emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA) It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	baseline, pre-intervention
Changes in emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	Post-intervention (one week after the intervention)
Fluctuations in emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	6 months Follow-up
Changes of rational and irrational beliefs	The Child and Adolescent Scale of Irrationality will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")	Post-intervention (one week after the intervention)
Levels of child behavioral difficulties	Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.	Pre-intervention (one week before the intervention)
Changes in child behavioral difficulties	Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.	Post-intervention (one week after the intervention)
Fluctuations in child behavioral difficulties	Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in emotional distress	The Profile of Emotional Distress is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).	Post-intervention (one week after the intervention)
Level of emotional distress	The Profile of Emotional Distress (PED) is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).	baseline, pre-intervention
Fluctuations in emotional distress	The Profile of Emotional Distress is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).	6 months follow-up

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Collaborators: The Executive Agency for Higher Education, Research, Development and Innovation Funding

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2023
• Primary Completion (Actual): November 10, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: REThink SMARTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No