Clinical trial NCT06720792: Cocreation and Evaluation of an Escape Game on Students' Mental Health
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: cocreation
evaluation
randomised controlled trial
students
mental health
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
Collaborators: name: David Labrosse
name: Clara Vié
First posted: 2024-12-06
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Mental Health Literacy Scale
timeFrame: 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
measure: The Health Belief Model Scale
timeFrame: 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.
measure: The Differential Emotions Scale
timeFrame: 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
measure: The Ways of Coping strategy Questionnaire
timeFrame: 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
measure: Acceptability and relevance of the game
timeFrame: One week after having played the Escape Game or having received the email.
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux Population Health U1219
Study officials:
References:
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citation: 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.
citation: 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.