REThink GameREThinkChronicNCT05163938
REThink Chronic-A Mobile Therapeutic Game
A study testing REThink Therapeutic Game and Treatment as Usual in people with REThink Game and Treatment-as-usual, run by Babes-Bolyai University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- REThink Game, Treatment-as-usual
- What is being tested?
- REThink Therapeutic Game and Treatment as Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteRomania
- Study dates
- 10 Jan 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease
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.
Read the 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
- Being tested
- REThink Therapeutic Game, Treatment as Usual
- Keywords
- chronic physical disease, youth, emotional disorders, therapeutic game, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink Therapeutic GameDevice
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 UsualDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| REThink therapeutic game | Experimental | 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) Receives: Device: REThink Therapeutic Game |
| Treatment as usual | Active comparator | 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. Receives: Device: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's emotional symptoms
The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Goodman et al.,1998)
Measured: 7 months
Children's negative and positive affect
The Positive and Negative Affect Schedule (PANAS-C; Laurent et al, 1999)
Measured: 7 months
Secondary outcomes (4)
Child emotion regulation
The Cognitive Emotion Regulation Scale (CERQ-K; Orgilés, 2017) aims to identify the emotional cognitive regulation strategies that a child uses after going through negative or stressful events.
Measured: 7 months
Children's irrational beliefs
The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999) will be used in order to test irrational/ rational beliefs as a mechanism of change.
Measured: 7 months
Children's quality of life
Youth Quality of Life Instrument - Short Form (YQOL-SF- Edwards, Huebner, Connell \& Patrick, 2002; Patrick, Edwards \& Topolski, 2002) is a questionnaire which assesses the general quality of life in children and adolescents aged 11 to 18 years old with and without chronic diseases and disabilities. The short form consists of 15 items which evaluate the domains of sense of self, social relationships, environment, and general quality of life.
Measured: 7 months
Emotional state
MoodWheel (MoodWheel; David, 2016) is a web and mobile application that includes procedures for sampling experience in order to assess present/past emotional difficulties, as well as positive emotions. The purpose of the mobile app is to examine the validity, control and functionality of the emotion felt by the participant.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start10 Jan 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REThink GameStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- REThink mobile therapeutic game intervention group and Treatment-as-usual group which receives the trial version of the app.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
- Investigators
- Oana David, PhD, Study director, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163938
- Sponsor's protocol ID
- REThink Chronic
- Acronym
- REThinkChronic
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2021
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease
- ClinicalTrials.gov ID
- NCT05163938
- Acronym / sponsor ID
- REThinkChronic / REThink Chronic
- Conditions
- REThink Game, Treatment-as-usual
- Keywords
- chronic physical disease, youth, emotional disorders, therapeutic game, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- REThink mobile therapeutic game intervention group and Treatment-as-usual group which receives the trial version of the app.
| Arm | Type | Receives |
|---|---|---|
| REThink therapeutic game | Experimental | Device: REThink Therapeutic GameGame 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 | Active comparator | Device: Treatment as UsualIn 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REThink Therapeutic GameGame 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) | Device | REThink therapeutic game |
| Treatment as UsualTreatment 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. | Device | Treatment as usual |
Primary outcome
Children's emotional symptoms
Time frame: 7 months
The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Goodman et al.,1998)
Children's negative and positive affect
Time frame: 7 months
The Positive and Negative Affect Schedule (PANAS-C; Laurent et al, 1999)
4 secondary outcomes
Child emotion regulation
Time frame: 7 months
Children's irrational beliefs
Time frame: 7 months
Children's quality of life
Time frame: 7 months
Emotional state
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oana David, PhD study director
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REThink Therapeutic Game and Treatment as Usual in people with REThink Game and Treatment-as-usual, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's emotional symptoms (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.