Emotional StressNCT04763954
Guided and Unguided Therapeutic Game to Improve Emotional Abilities of Students
A study testing Rethink therapeutic game in people with Emotional Stress, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The aim of the study is to investigate the efficiency of a therapeutic online game, with and without coaching, in training emotional abilities of students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress
- What is being tested?
- Rethink therapeutic game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteRomania
- Study dates
- 15 Feb 2021to 30 Apr 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being a student in a public or private university from Romania
Who cannot join
- not being enrolled as a student in a university from Romania
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Therapeutic Game With or Without Email Coaching in Improving the Emotional Abilities in Students
The aim of the study is to investigate the efficiency of a therapeutic online game, with and without coaching, in training emotional abilities of students.
Read the detailed description
The study is a randomized control trial with three groups. We will perform measurements before the intervention, after the intervention and at one month follow-up.
Participants will be students and will be randomized into three groups using a randomization program. The first group will be the gaming with coaching group, the second group will bw the gaming without coaching group and the third group will be the control group.
Measurements will be performed before receiving the game, after the intervention and at one month follow-up. We will measure depression, anxiety, stress and well-being as primary outcomes, solution focus orientation as secondary outcome and rational and irrational cognitions as mechanism outcome. All questionnaires will be completed online in a Google Form.
The intervention will consist of the Rethink game. Rethink is a therapeutic game developed and tested to improve emotional abilities in children. Participants in our study will test two levels of Rethink as well as a trial version of the game. Each level of the game is focused on a component:
- Level 1: recognition of emotions
- Level 2: relaxation and mindfulness
- Level 3: rational and irrational cognitions
- Level 4:changing the cognitions
- Level 5: problem-solving
- Level 6: positive emotions
- Level 7: summary of previous aqusitions
- Conditions
- Emotional Stress
- Being tested
- Rethink therapeutic game
- Keywords
- emotional skills, emotional abilities, stress, relaxation
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rethink therapeutic gameOther
The Rethink therapeutic game is a 7 levels online game developed and tested for children. Each level is based on a specific skill and its efficiency has been previously studies in children.
| Study group | Role | What they receive |
|---|---|---|
| Game | Experimental | Group that receives the game intervention (the trial version and the access to level 2 and level 7 Receives: Other: Rethink therapeutic game |
| Control | No intervention | Group without intervention |
| Guidance | Experimental | Group that receives the game (the same levels as group 1) and email coaching one day after completing the game. Receives: Other: Rethink therapeutic game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline emotions
Measured with Profile of Emotional Distress
Measured: Pre-intervention (one day before the intervention)
Emotions after intervention in a stressful condition
Measured with Profile of Emotional Distress
Measured: Post-intervention - before a stressful event (before an exam)
Changes in time in emotions after intervention
Measured with Profile of Emotional Distress
Measured: Post-intervention at one month after the intervention
Secondary outcomes (3)
Baseline cognitions
Measured with Attitudinal Beliefs Scale
Measured: Pre-intervention (one day before the intervention)
Cognitions after intervention in stress condition
Measured with Attitudinal Beliefs Scale
Measured: Post-intervention - before a stressful event (before an exam)
Changes in time in cognitions after intervention
Measured with Attitudinal Beliefs Scale
Measured: Post-intervention at one month 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 Feb 2021
- Study start15 Feb 2021
- Primary completion20 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Game and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Lorint, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763954
- Sponsor's protocol ID
- 1396/ 10.02.2021
- Status last verified
- May 2021
- First submitted
- 15 Feb 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tomoiaga C, David O. The Efficacy of Guided and Unguided Game-Based Cognitive-Behavioral Therapy in Reducing Distress in College Students. Games Health J. 2022 Sep 6. doi: 10.1089/g4h.2021.0195. Online ahead of print.
PubMed 36067336
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Therapeutic Game With or Without Email Coaching in Improving the Emotional Abilities in Students
- ClinicalTrials.gov ID
- NCT04763954
- Acronym / sponsor ID
- 1396/ 10.02.2021
- Conditions
- Emotional Stress
- Keywords
- emotional skills, emotional abilities, stress, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 21 Feb 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 aim of the study is to investigate the efficiency of a therapeutic online game, with and without coaching, in training emotional abilities of students.
Detailed description
The study is a randomized control trial with three groups. We will perform measurements before the intervention, after the intervention and at one month follow-up.
Participants will be students and will be randomized into three groups using a randomization program. The first group will be the gaming with coaching group, the second group will bw the gaming without coaching group and the third group will be the control group.
Measurements will be performed before receiving the game, after the intervention and at one month follow-up. We will measure depression, anxiety, stress and well-being as primary outcomes, solution focus orientation as secondary outcome and rational and irrational cognitions as mechanism outcome. All questionnaires will be completed online in a Google Form.
The intervention will consist of the Rethink game. Rethink is a therapeutic game developed and tested to improve emotional abilities in children. Participants in our study will test two levels of Rethink as well as a trial version of the game. Each level of the game is focused on a component:
- Level 1: recognition of emotions
- Level 2: relaxation and mindfulness
- Level 3: rational and irrational cognitions
- Level 4:changing the cognitions
- Level 5: problem-solving
- Level 6: positive emotions
- Level 7: summary of previous aqusitions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Game and control
| Arm | Type | Receives |
|---|---|---|
| Game | Experimental | Other: Rethink therapeutic gameGroup that receives the game intervention (the trial version and the access to level 2 and level 7 |
| Control | No intervention | –Group without intervention |
| Guidance | Experimental | Other: Rethink therapeutic gameGroup that receives the game (the same levels as group 1) and email coaching one day after completing the game. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being a student in a public or private university from Romania
Key exclusion criteria (1 listed)
- not being enrolled as a student in a university from Romania
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 gameThe Rethink therapeutic game is a 7 levels online game developed and tested for children. Each level is based on a specific skill and its efficiency has been previously studies in children. | Other | Game, Guidance |
Primary outcome
Baseline emotions
Time frame: Pre-intervention (one day before the intervention)
Measured with Profile of Emotional Distress
Emotions after intervention in a stressful condition
Time frame: Post-intervention - before a stressful event (before an exam)
Measured with Profile of Emotional Distress
Changes in time in emotions after intervention
Time frame: Post-intervention at one month after the intervention
Measured with Profile of Emotional Distress
3 secondary outcomes
Baseline cognitions
Time frame: Pre-intervention (one day before the intervention)
Cognitions after intervention in stress condition
Time frame: Post-intervention - before a stressful event (before an exam)
Changes in time in cognitions after intervention
Time frame: Post-intervention at one month after the intervention
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 27 May 2021.
- Derived from this study: PubMed 36067336Tomoiaga C, David O. The Efficacy of Guided and Unguided Game-Based Cognitive-Behavioral Therapy in Reducing Distress in College Students. Games Health J. 2022 Sep 6. doi: 10.1089/g4h.2021.0195. Online ahead of print.
Related trials for Emotional Stress
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Recruiting
Trauma-Informed Yoga Intervention in Young Women
Trauma, Young Adult Females
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 therapeutic game in people with Emotional Stress, 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 1 inclusion and 1 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 27 May 2021. 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?
Baseline emotions (time frame: Pre-intervention (one day before the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763954, which also lists 1 linked publication.
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 27 May 2021.