- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763954
Guided and Unguided Therapeutic Game to Improve Emotional Abilities of Students
The Effect of a Therapeutic Game With or Without Email Coaching in Improving the Emotional Abilities in Students
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400540
- Cristinalorint@Psychology.Ro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being a student in a public or private university from Romania
Exclusion Criteria:
- not being enrolled as a student in a university from Romania
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Game
Group that receives the game intervention (the trial version and the access to level 2 and level 7
|
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.
|
No Intervention: Control
Group without intervention
|
|
Experimental: Guidance
Group that receives the game (the same levels as group 1) and email coaching one day after completing the game.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline emotions
Time Frame: Pre-intervention (one day before the intervention)
|
Measured with Profile of Emotional Distress
|
Pre-intervention (one day before the intervention)
|
Emotions after intervention in a stressful condition
Time Frame: Post-intervention - before a stressful event (before an exam)
|
Measured with Profile of Emotional Distress
|
Post-intervention - before a stressful event (before an exam)
|
Changes in time in emotions after intervention
Time Frame: Post-intervention at one month after the intervention
|
Measured with Profile of Emotional Distress
|
Post-intervention at one month after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline cognitions
Time Frame: Pre-intervention (one day before the intervention)
|
Measured with Attitudinal Beliefs Scale
|
Pre-intervention (one day before the intervention)
|
Cognitions after intervention in stress condition
Time Frame: Post-intervention - before a stressful event (before an exam)
|
Measured with Attitudinal Beliefs Scale
|
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
|
Measured with Attitudinal Beliefs Scale
|
Post-intervention at one month after the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1396/ 10.02.2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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