NCT06720792

Brief Summary

The Covid-19 pandemic and the protracted lockdowns have heavily impacted university students' mental health. Digital Escape Games represent a good means to reach students and propose them solutions for their psychological well-being. The objective of the study is to evaluate a cocreated digital Escape Game on students' mental health in the Covid-19 era. The evaluation of the effectiveness of this stand-alone intervention concerns mental health outcomes (mental health literacy, appraisal and change of beliefs about mental health, recognition and management of emotions, and positive coping strategies) and the appreciation and relevance of the game. A randomized controlled trial with pre- and post-test data collection (online questionnaires with validated scales) will be conducted among 500 students in Bordeaux, France, to evaluate a game cocreated with students, researchers, health professionals and web-developers. A sub-sample of students will be randomly selected for responding to a semi-structured interview following a mixed methods design. Recruitment will be done through mail invitation from student associations and presentations in university classes. Half of the sample (250 students) will play the Escape Game, while the other half will receive an email with mental health-related information. The whole study is carried out online. As of December 2nd 2024, 191 students have answered the baseline questionnaire (90 intervention vs. 101 control). Twenty-three students have played the Escape Game and 53 are in the control arm. The current sample size is too small for reaching significance level. Among participants, 20 were interviewed (10 intervention vs. 10 control) reaching the saturation of the sample. According to preliminary results, the game has proved a positive impact on all defined outcomes, while the email has been effective in increasing knowledge on resources available and on coping strategies and meditation techniques. We expect the trial to be completed by the end of June 2025. Preliminary results from the qualitative sub-study are promising: in the aftermaths of the Covid-19 crisis, this intervention is intended to promote players' mental health through gamification, knowledge transfer and a learning-by-doing approach.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
191

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

November 27, 2024

Last Update Submit

December 2, 2024

Conditions

Keywords

cocreationevaluationrandomised controlled trialstudentsmental health

Outcome Measures

Primary Outcomes (5)

  • The Mental Health Literacy Scale

    Validated scale on knowledge, information and beliefs about mental health. Score range from 35 to 160. There are no categories, it is a continuous score.

    Up to 3 months (baseline + one week + one month and three months after having played the Escape Game or having received the email.the email

  • The Health Belief Model Scale

    Validated scale on how we perceive and represent health in general and mental health in particular

    Up to 3 months (baseline + one week + one month and three months after having played the Escape Game or having received the email. Score ranges from 1 to 5, continuous variable.

  • The Differential Emotions Scale

    Validated scale for assessment of an individual's emotions. Mean, standard deviation, variance.

    Up to 3 months (baseline + one week + one month and three months after having played the Escape Game or having received the email.the email

  • The Ways of Coping strategy Questionnaire

    Validated questionnaire describing one's resilience and knowledge of strategies to promote (mental) health and prevent (mental) diseases

    Up to 3 months (baseline + one week + one month and three months after having played the Escape Game or having received the email.the email

  • Acceptability and relevance of the game

    Ad hoc items to describe the appreciation of the game. Sum of the answers, continuous variable.

    One week after having played the Escape Game or having received the email.

Study Arms (2)

Game play

ACTIVE COMPARATOR

Participants receive an email with the link to book a slot to play the Escape Game. The date when students can play the Escape Game is defined when 4 students are available at the same slot. Students receive a further email with all the instructions to play the game.

Other: EscapeCovid

email on mental health-related information

PLACEBO COMPARATOR

Students receive an email detailing mental health services and describing the most common mental health problems. Participants are randomized so that the two groups are similar in terms of sex, age and field of study (stratified balanced randomization).

Other: EscapeCovid

Interventions

Online Escape Game with 4 players and a game guide. The players, in a group, must solve enigmas to win.

Game playemail on mental health-related information

Eligibility Criteria

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

You may qualify if:

  • university students
  • understanding and speaking French
  • being aged more than 18 years old

You may not qualify if:

  • not enrolled in a French university
  • minor
  • not understanding and speaking French
  • not having given one's electronic consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux Population Health U1219

Bordeaux, 33000, France

RECRUITING

Related Publications (9)

  • Vie C, Govindin-Ramassamy K, Thellier D, Labrosse D, Montagni I. Effectiveness of digital games promoting young people's mental health: A review of reviews. Digit Health. 2024 Feb 5;10:20552076231220814. doi: 10.1177/20552076231220814. eCollection 2024 Jan-Dec.

    PMID: 38323239BACKGROUND
  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PMID: 21513547BACKGROUND
  • Plutchik R. The measurement of emotions. Acta Neuropsychiatr. 1997 Jun;9(2):58-60. doi: 10.1017/S0924270800036802.

    PMID: 26972127BACKGROUND
  • Montagni I, Gonzalez Caballero JL. Validation of the Mental Health Literacy Scale in French University Students. Behav Sci (Basel). 2022 Jul 28;12(8):259. doi: 10.3390/bs12080259.

    PMID: 36004830BACKGROUND
  • Janz NK, Becker MH. The Health Belief Model: a decade later. Health Educ Q. 1984 Spring;11(1):1-47. doi: 10.1177/109019818401100101.

    PMID: 6392204BACKGROUND
  • Aschentrup L, Steimer PA, Dadaczynski K, Mc Call T, Fischer F, Wrona KJ. Effectiveness of gamified digital interventions in mental health prevention and health promotion among adults: a scoping review. BMC Public Health. 2024 Jan 2;24(1):69. doi: 10.1186/s12889-023-17517-3.

    PMID: 38167010BACKGROUND
  • Arrue M, Suarez N, Ugartemendia-Yerobi M, Babarro I. Let's play and learn: Educational escape room to improve mental health knowledge in undergraduate nursing students. Nurse Educ Today. 2025 Jan;144:106453. doi: 10.1016/j.nedt.2024.106453. Epub 2024 Oct 11.

    PMID: 39418755BACKGROUND
  • Labrosse D, Vie C, Hajjam H, Tisseron C, Thellier D, Montagni I. An Escape Game on University Students' Mental Health During the COVID-19 Pandemic: Cocreation Study. JMIR Serious Games. 2024 Mar 18;12:e48545. doi: 10.2196/48545.

  • Labrosse D, Vie C, Harb M, Montagni I. Escape Game to Promote Students' Mental Health Outcomes in the Aftermaths of COVID-19 Pandemic: Protocol for a Mixed Methods Study Evaluating a Cocreated Intervention. JMIR Res Protoc. 2025 Apr 2;14:e64068. doi: 10.2196/64068.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Ilaria Montagni Lecturer-researcher, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer-researcher

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 6, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations