NCT04763954

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

February 15, 2021

Last Update Submit

May 25, 2021

Conditions

Keywords

emotional skillsemotional abilitiesstressrelaxation

Outcome Measures

Primary Outcomes (3)

  • Baseline emotions

    Measured with Profile of Emotional Distress

    Pre-intervention (one day before the intervention)

  • Emotions after intervention in a stressful condition

    Measured with Profile of Emotional Distress

    Post-intervention - before a stressful event (before an exam)

  • Changes in time in emotions after intervention

    Measured with Profile of Emotional Distress

    Post-intervention at one month after the intervention

Secondary Outcomes (3)

  • Baseline cognitions

    Pre-intervention (one day before the intervention)

  • Cognitions after intervention in stress condition

    Post-intervention - before a stressful event (before an exam)

  • Changes in time in cognitions after intervention

    Post-intervention at one month after the intervention

Study Arms (3)

Game

EXPERIMENTAL

Group that receives the game intervention (the trial version and the access to level 2 and level 7

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.

Other: Rethink therapeutic game

Interventions

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.

GameGuidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being a student in a public or private university from Romania

You may not qualify if:

  • not being enrolled as a student in a university from Romania

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristinalorint@Psychology.Ro

Cluj-Napoca, Cluj, 400540, Romania

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Game and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D Student

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 21, 2021

Study Start

February 15, 2021

Primary Completion

March 20, 2021

Study Completion

April 30, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations