REThink Chronic-A Mobile Therapeutic Game

NCT ID: NCT05163938

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2025-06-01

Brief Summary

The general objective of the study is to test the efficacy of an online therapeutic game (REThink Game) for the prevention of emotional disorders in children and adolescents aged between 8-16 years with a chronic physical disease.

Detailed Description

The objective of the study is to test an online therapeutic game which, being an evidence-based prevention tool for children and adolescents, might contribute to preventing emotional disorders in children and adolescents aged between 8-16 years old diagnosed with a chronic physical disease. REThink is a scientifically validated therapeutic game for children and adolescents to improve their emotional skills. The enrollment will take place both online and in pediatric medical institutions. The research study will include one parent of the eligible child/adolescent. The children and adolescents will be randomized into two equal groups: the intervention group which benefits of the entire REThink game and the treatment-as-usual group which benefits of a free trial version of the app. Three assessments will be performed to evaluate the variables of interest: before intervention (baseline), after intervention (post-intervention), and a follow-up six months after the post-intervention assessment was performed.

Conditions

REThink Game; Treatment-as-usual

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

REThink therapeutic game

Game based Cognitive-Behavioral Therapy: REThink therapeutic game is an online therapeutic game developed by David and collaborators (2018).

The seven levels of the game were developed based on the REBT model and each level trains an ability:

Level 1: identify the emotional reactions, and differentiating between basic emotions, complex emotions, and functional and dysfunctional emotions; Level 2: identify cognitive processes.

Level 3: identify the relation between cognitive processes, emotions, and behavioral reactions; Level 4: change irrational cognitions into rational cognitions; Level 5: build problem-solving skills; Level 6: build relaxation skills; Level 7: consolidate of the previous skills and building happiness skills. A new level will be unlocked once every three days. In order for a level to be unlocked, the previous one must have been completed.

Duration of the intervention: 21 days (a total of seven levels unlocked every three days)

Group Type: EXPERIMENTAL

REThink Therapeutic Game

Intervention Type: DEVICE

Game based Cognitive-Behavioral Therapy: REThink therapeutic game is an online therapeutic game developed by David and collaborators (2018).

The seven levels of the game were developed based on the REBT model and each level trains an ability:

Level 1: identify the emotional reactions, and differentiating between basic emotions, complex emotions, and functional and dysfunctional emotions; Level 2: identify cognitive processes.

Level 3: identify the relation between cognitive processes, emotions, and behavioral reactions; Level 4: change irrational cognitions into rational cognitions; Level 5: build problem-solving skills; Level 6: build relaxation skills; Level 7: consolidate of the previous skills and building happiness skills. A new level will be unlocked once every three days. In order for a level to be unlocked, the previous one must have been completed.

Duration of the intervention: 21 days (a total of seven levels unlocked every three days)

Treatment as usual

In the treatment as usual group the child/adolescent benefits from a free trial version of the REThink game which means a shorter version of each level of the game.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: DEVICE

Treatment As Usual: In the treatment as usual group the child/adolescent benefits from a free trial version of the REThink game which means a shorter version of each level of the game.

Interventions

REThink Therapeutic Game

Game based Cognitive-Behavioral Therapy: REThink therapeutic game is an online therapeutic game developed by David and collaborators (2018).

The seven levels of the game were developed based on the REBT model and each level trains an ability:

Level 1: identify the emotional reactions, and differentiating between basic emotions, complex emotions, and functional and dysfunctional emotions; Level 2: identify cognitive processes.

Level 3: identify the relation between cognitive processes, emotions, and behavioral reactions; Level 4: change irrational cognitions into rational cognitions; Level 5: build problem-solving skills; Level 6: build relaxation skills; Level 7: consolidate of the previous skills and building happiness skills. A new level will be unlocked once every three days. In order for a level to be unlocked, the previous one must have been completed.

Duration of the intervention: 21 days (a total of seven levels unlocked every three days)

Intervention Type: DEVICE

Treatment as Usual

Treatment As Usual: In the treatment as usual group the child/adolescent benefits from a free trial version of the REThink game which means a shorter version of each level of the game.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• are aged 8 to 16 years old
• are diagnosed with a chronic physical disease
• have consent from the parent or legal tutor to participate in the study
• are fluent in Romanian
• have access to a mobile phone, tablet or laptop

Exclusion Criteria

• have intellectual disabilities or physical limitations which make it impossible for the them to play the game
• have traumatic brain injuries
• have a diagnosed mental disorder
• demised during the study period

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Babes-Bolyai University

OTHER

Sponsor Role: lead

Responsible Party

Oana David

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oana David, PhD

Role: STUDY_DIRECTOR

Babes-Bolyai University

Locations

Babes-Bolyai University

Cluj-Napoca, , Romania

Countries

Romania

Other Identifiers

REThink Chronic

Identifier Type: -

Identifier Source: org_study_id