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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04763954
Other study ID # 1396/ 10.02.2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date April 30, 2021

Study information

Verified date May 2021
Source Babes-Bolyai University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date April 30, 2021
Est. primary completion date March 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Rethink therapeutic 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.

Locations

Country Name City State
Romania Cristinalorint@Psychology.Ro Cluj-Napoca Cluj

Sponsors (1)

Lead Sponsor Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline emotions Measured with Profile of Emotional Distress Pre-intervention (one day before the intervention)
Primary Emotions after intervention in a stressful condition Measured with Profile of Emotional Distress Post-intervention - before a stressful event (before an exam)
Primary Changes in time in emotions after intervention Measured with Profile of Emotional Distress Post-intervention at one month after the intervention
Secondary Baseline cognitions Measured with Attitudinal Beliefs Scale Pre-intervention (one day before the intervention)
Secondary Cognitions after intervention in stress condition Measured with Attitudinal Beliefs Scale Post-intervention - before a stressful event (before an exam)
Secondary Changes in time in cognitions after intervention Measured with Attitudinal Beliefs Scale Post-intervention at one month after the intervention
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