NCT05896085

Brief Summary

The aim of this study will be to investigate the validity of the in-game performance measurements or scores as indicators of students'ER abilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

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

May 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

May 26, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

online therapeutic gameemotion regulationcollege studentsmental healthgame-based assessment

Outcome Measures

Primary Outcomes (2)

  • Mental Health

    The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg \&Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 "never" to 5 "everyday" where grater scores represents better mental health.

    baseline, pre-intervention

  • Emotion regulation

    The Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, \& Spinhoven, 2001) is a self-report scale measuring emotion regulation on a 5 point Likert scale ranging from "almost never" to "almost always". It had 9 subscales representing 9 emotion regulation strategies and grater scores represents grater involvement in using that strategy.

    baseline, pre-intervention

Secondary Outcomes (5)

  • MAAS

    baseline, pre-intervention

  • Rational and irrational cognition

    baseline, pre-intervention

  • Atention to positive and negative information

    baseline, pre-intervention

  • emotional distress

    baseline, pre-intervention

  • emotional awareness

    baseline, pre-intervention

Study Arms (1)

REThink game

EXPERIMENTAL

Participants will complete the online standardized scales and then complete the REThink therapeutic game's assessment system in 3D or VR version.

Other: REThink game

Interventions

The Rethink therapeutic game is an online game developed based on Rational-Emotive Behavioral Therapy and has two versions: for children and adolescents and for adults. The Rethink therapeutic game for adults is available in 3D and VR version and consists of four levels, each of them training a specific emotion regulation ability such as: emotional awareness, mindfulness, cognitive change

REThink game

Eligibility Criteria

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

You may qualify if:

  • first year student at Babes-Bolyai University
  • internet and PC access to complete the scales and game

You may not qualify if:

  • no internet or PC access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Emotional RegulationPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ph.D of Clinical Psychology

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 9, 2023

Study Start

July 1, 2023

Primary Completion

November 29, 2023

Study Completion

November 29, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations