Emotion RegulationNCT05424601
Intervention in a Small-scale Study of Game Based Cognitive Change Skills
A study testing Rethink game and PsyPills in people with Emotion Regulation, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Rethink game and PsyPills
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteRomania
- Study dates
- 10 Jun 2022to 7 Sep 2022
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children and adolescents between 10 and 16 years old
- provided written parental consent
- able to access mobile/internet applications on their device
Who cannot join
- Intellectual disability or physical limitations precluded the use of the computer program
- Had a major mental health disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching with or Without EMI
This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy
Read the detailed description
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
- Emotion Regulation
- Being tested
- Rethink game, PsyPills
- Keywords
- online therapeutic game, emotional problems, emotional regulation, children and adolescents
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rethink gameBehavioural
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.
PsyPillsBehavioural
PsyPills is a mobile app designed to provide personalized psychological pills
| Study group | Role | What they receive |
|---|---|---|
| Rethink game plus PsyPills | Experimental | Rethink game followed by PsyPills Receives: Behavioral: Rethink game; Behavioral: PsyPills |
| Rethink Game | Experimental | Rethink game only Receives: Behavioral: Rethink game |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of rational and 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. 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")
Measured: Baseline
Changes in levels of rational and 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. 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")
Measured: Post-intervention (one week after the intervention)
Emotion regulation abilities
The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Measured: Baseline
Changes in emotion regulation abilities
The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Measured: Post-intervention (one week after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start10 Jun 2022
- Primary completion5 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424601
- Sponsor's protocol ID
- RETthinkEMOTIONS3
- Status last verified
- Dec 2024
- First submitted
- 15 Jun 2022
- Last updated
- 4 Dec 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching with or Without EMI
- ClinicalTrials.gov ID
- NCT05424601
- Acronym / sponsor ID
- RETthinkEMOTIONS3
- Conditions
- Emotion Regulation
- Keywords
- online therapeutic game, emotional problems, emotional regulation, children and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 21 Jun 2022 (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.
This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rethink game plus PsyPills | Experimental | Behavioral: Rethink game, Behavioral: PsyPillsRethink game followed by PsyPills |
| Rethink Game | Experimental | Behavioral: Rethink gameRethink game only |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children and adolescents between 10 and 16 years old
- provided written parental consent
- able to access mobile/internet applications on their device
Key exclusion criteria (2 listed)
- Intellectual disability or physical limitations precluded the use of the computer program
- Had a major mental health disorder
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 gameREThink 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. | Behavioural | Rethink Game, Rethink game plus PsyPills |
| PsyPillsPsyPills is a mobile app designed to provide personalized psychological pills | Behavioural | Rethink game plus PsyPills |
Primary outcome
Levels of rational and irrational beliefs
Time frame: Baseline
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. 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")
Changes in levels of rational and irrational beliefs
Time frame: Post-intervention (one week after the intervention)
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. 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")
Emotion regulation abilities
Time frame: Baseline
The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Changes in emotion regulation abilities
Time frame: Post-intervention (one week after the intervention)
The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 game and PsyPills in people with Emotion Regulation, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Levels of rational and irrational beliefs (time frame: Baseline). The study lists 4 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 4 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.