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Intervention in a Small-scale Study of Game Based Cognitive Change Skills

NCT ID: NCT05424601

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2022-09-07

Brief Summary

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This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy

Detailed Description

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Preliminary efficacy will be tested in an emotion-regulation framework. Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition. Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation. Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.

Conditions

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Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Rethink game plus PsyPills

Rethink game followed by PsyPills

Group Type EXPERIMENTAL

Rethink game

Intervention Type BEHAVIORAL

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.

PsyPills

Intervention Type BEHAVIORAL

PsyPills is a mobile app designed to provide personalized psychological pills

Rethink Game

Rethink game only

Group Type EXPERIMENTAL

Rethink game

Intervention Type BEHAVIORAL

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.

Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rethink game

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.

Intervention Type BEHAVIORAL

PsyPills

PsyPills is a mobile app designed to provide personalized psychological pills

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children and adolescents between 10 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Executive Agency for Higher Education, Research, Development and Innovation Funding

OTHER

Sponsor Role collaborator

Babes-Bolyai University

OTHER

Sponsor Role lead

Responsible Party

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Oana David

Professor Ph.D of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

Other Identifiers

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RETthinkEMOTIONS3

Identifier Type: -

Identifier Source: org_study_id