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

Sponsor
Babes-Bolyai University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06085391
Collaborator
The Executive Agency for Higher Education, Research, Development and Innovation Funding (Other)
180
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64.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: REThink Game
  • Other: MoodWheel
  • Other: PsyPills
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study
Actual Study Start Date :
Oct 7, 2023
Anticipated Primary Completion Date :
Nov 10, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Levels of rational and irrational beliefs [baseline, pre-intervention]

    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")

  2. Changes of rational and irrational beliefs [Post-intervention (one week after the intervention)]

    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")

  3. Fluctuations in of rational and irrational beliefs [6 months Follow-up]

    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")

  4. Levels of emotion-regulation [baseline, pre-intervention]

    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,

  5. Changes in emotion-regulation [Post-intervention (one week after the intervention)]

    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. Fluctuations in emotion-regulation [6 months Follow-up]

    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,

  7. Levels of child behavioral difficulties [Pre-intervention (one week before the intervention)]

    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.

  8. Changes in child behavioral difficulties [Post-intervention (one week after the intervention)]

    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.

  9. Fluctuations in child behavioral difficulties [6 months follow-up]

    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.

Secondary Outcome Measures

  1. Level of emotional distress [baseline, pre-intervention]

    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).

  2. Changes in emotional distress [Post-intervention (one week after the intervention)]

    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).

  3. Fluctuations in emotional distress [6 months follow-up]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Babes-Bolyai University Cluj-Napoca Romania

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oana David, Professor Ph.D of Clinical Psychology, Babes-Bolyai University
ClinicalTrials.gov Identifier:
NCT06085391
Other Study ID Numbers:
  • REThink SMARTrial
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 23, 2023