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Mental HealthEscapeCovidNCT06720792

Cocreation and Evaluation of an Escape Game on Students' Mental Health

A study testing EscapeCovid in people with Mental Health, run by University of Bordeaux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
EscapeCovid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
191 participants
Where
1 siteFrance
Study dates
1 Jan 2022to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ilaria Montagni Lecturer-researcher, PhD contact

00330642193363

ilaria.montagni@u-bordeaux.fr

France1 site, 1 recruiting
  • Bordeaux Population Health U1219

    Bordeaux, 33000

    Recruiting

Other trials in France

About this study

Official title: An Escape Game to Promote Students' Mental Health Outcomes in the Aftermaths of Covid-19 Pandemic: Protocol for a Randomized Controlled Trial Evaluating a Cocreated Intervention

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.

Read more

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.

Read the detailed description

The main objective of this study is to evaluate through a randomized controlled trial and semi-structured interviews (mixed methods design) an intervention on mental health promotion and on psychological disease prevention in the form of a digital Escape Game addressed to University students in the era of Covid-19.

The specific objectives of the study are:

  1. assessing among students the effectiveness of the digital Escape Game in (a) increasing players' mental health literacy, (b) helping appraise and change students' beliefs about mental health, (c) supporting recognition and management of their emotions, and (d) teaching them useful positive coping strategies;
  2. assessing the impact of the digital Escape Game on participants' levels of anxiety, stress and depression; and
  3. questioning the appreciation and relevance of the digital Escape Game among students.

Consequential research hypotheses of the study are:

  1. compared to the control group receiving another intervention, after playing the digital Escape Game, students have remarkably improved the following mental health indicators: mental health literacy, identification and positive change of beliefs about mental health, recognition and management of emotions, and adoption of positive coping strategies;
  2. the intervention group also presents reduced levels of anxiety, depression and stress after having played the game one week, one month and three months after the intervention (comparison with the control group and within the group); and
  3. digital Escape Games are considered as appealing and relevant by students when treating mental health.

The Escape Game will be evaluated through a rigorous Randomized Controlled Trial (RCT) design using pre- and post-intervention data coming from a repeated online self-administered questionnaire. The investigators will compare the answers between exposed and non-exposed students (inter-group) and measure the change in their answers at three timepoints (intra-group). The investigators will recruit at least 500 students at the University of Bordeaux, France (this number has been confirmed with a statistical power calculation targeting participants in each arm to achieve 80% to 90% power to detect a small effect - f = 0.09 to f = 0.10 - for differential change in the 2 arms, with α = .05.) representative of the student population in Bordeaux for sex, year and field of study, according to the statistics of the University of Bordeaux. Students will be invited through posts on the social media of the study partners and mailing lists from the University of Bordeaux. Inclusion criteria are: being a student in Bordeaux, being aged ≥18 years and having given the electronic consent to participate to the study (check the "I agree" box to be enrolled in the study, after having read its conditions). After having signed the consent form, students can access the baseline questionnaire. Based on the completion of the questionnaires, the recruitment will end once the sample is composed of at least 500 students (this will be checked by a continuous monitoring through descriptive analysis). At the end of the baseline questionnaire, participants will be allocated to either the intervention or the control group through a random assignment. Thus, 250 students will play online the Escape Game, while 250 students will receive an email with tips and resources for managing their stress during the Covid-19 pandemic. Participants will be randomized so that the two groups are similar in terms of sex, age and field of study (stratified balanced randomization).

Briefly, the 250 students of the intervention arm will: (1) complete the baseline questionnaire, (2) play the Escape Room within the week after the baseline questionnaire, and (3) complete the same questionnaire of the baseline at three timepoints, i.e. one week, one month and three months after having played the game (follow-up). The 250 students of the control arm will: (1) complete the baseline questionnaire, (2) receive the same day an email with tips and resources to manage their stress during the Covid-19 pandemic, and (3) complete the same questionnaire of the baseline at three time points, i.e. one week, one month and three months after having received the email.

In the questionnaire sent after one week after having played the game, the intervention group will also have to respond to some items on the appreciation of the game (satisfaction survey). All participants will be rewarded with gift cards to maximize recruitment and follow-up (the gift card will be offered after the third follow-up at month 3).

Following a mixed methods design, 20 students will be randomly selected among the 250 having received the intervention to respond to a semi-structured interview. Data from these interviews is about commenting on the perceived improvement of the mental health indicators of the quantitative phase and about appreciation and relevance of the intervention. The sample will be composed in order to have different profiles, so that 20 is an approximative number of participants that could be higher or lower depending on the sample saturation. The interviews will be conducted based on an ad hoc grid, transcribed and analyzed through triangulation.

The questionnaires will include validated scales measuring mental health literacy (the Mental Health Literacy Scale - MHLS), health-related beliefs (the Health Belief Model - HBM), emotions (the Differential Emotions Scale - DES), coping strategies (the Ways of Coping strategy Questionnaire - WCQ), anxiety (Generalized Anxiety Disorder-7 (GAD-7), depression (Patient Health Questionnaire-9, (PHQ-9)) and stress (Perceived Stress Scale-4 (PSS-4)).

The items on appreciation/relevance of the intervention will be created ad hoc, but will also be inspired by existing instruments evaluating digital health interventions.

The final questionnaire will be developed by several researchers through different stages of drafts and reviews, following a structured survey construction method in 5 steps.

The response modalities will be varied: multiple choice, binary responses, Likert scales and visual analogue scales. Mental health indicators and appreciation/relevance results are the main outcomes of the study.

Analysis and interpretation of the data will follow the mixed methods approach: first, statistical analyses on quantitative data (descriptive statistics, modeling, exploratory data analysis); second, the discourse analysis of qualitative data (thematic analysis based on a pre-defined interview guide); and third, the coupled analysis of both types of data according to the explanatory design procedure. According to this procedure, qualitative data are used to explain the quantitative results.

Conditions
Mental Health
Being tested
EscapeCovid
Keywords
cocreation, evaluation, randomised controlled trial, students, mental health
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EscapeCovidOther

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

Study groups in NCT06720792
Study groupRoleWhat they receive
Game playActive comparatorParticipants 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.
Receives: Other: EscapeCovid
email on mental health-related informationPlacebo comparatorStudents 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).
Receives: Other: EscapeCovid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. The Health Belief Model Scale

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

    Measured: 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.

  3. The Differential Emotions Scale

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

    Measured: 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

  4. The Ways of Coping strategy Questionnaire

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

    Measured: 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

  5. Acceptability and relevance of the game

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
191 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06720792
Sponsor's protocol ID
ANR-21-CE36-0011
Other IDs
ANR-21-CE36- 0011-02
Acronym
EscapeCovid
Status last verified
Dec 2024
First submitted
27 Nov 2024
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified participant data will be available from the principal investigator upon request, exclusively after the conclusion of the trial.

Publications

  • 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.

    PubMed 38323239
  • 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.

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

    PubMed 26972127
  • 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.

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

    PubMed 6392204
  • 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.

    PubMed 38167010
  • 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.

    PubMed 39418755
  • 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.

    PubMed 38498033
  • 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.

    PubMed 40173436

Questions about this trial

What is this clinical trial studying?

A study testing EscapeCovid in people with Mental Health, run by University of Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ilaria Montagni Lecturer-researcher, PhD (00330642193363, ilaria.montagni@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Mental Health Literacy Scale (time frame: 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06720792, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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