Clinical trials

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.

The STIM-PRADER study aims to assess the effectiveness of auricular vagal neuromodulation therapy (aVNT) on emotional, behavioral, and cognitive domains impaired in Prader-Willi Syndrome (PWS). Currently, no treatment exists that addresses the multiple alterations associated with this rare neurodevelopmental disorder that significantly impact patients and their families. We will investigate the effects of daily, four-hour aVNT stimulation over a nine-month period on (a) emotion regulation, including assessing the persistence of effects following stimulation; (b) executive functions, including inhibition, flexibility, planning, and updating information in memory; (c) hyperphagia; (d) depression; (e) quality of life; (e) and the threshold at which effects on these dimensions can be observed. We will conduct a longitudinal multicenter parallel randomized controlled single-blind exploratory trial. Twenty-four adults with PWS and 24 caregivers will be randomly assigned to receive either active or sham stimulation under identical conditions (four hours per day, seven days per week over nine months). The primary outcome, focusing on emotional control, will be assessed every two weeks for both participants and caregivers. Secondary outcomes (executive functions, hyperphagia, depression, and quality of life) will be measured at four time points: pre-intervention, at three months, six months, and at nine months. As this is the first multicenter randomized controlled trial investigating the effects of aVNT as a treatment in PWS patients, we anticipate witnessing improved emotional regulation and reduced eating disorders, along with enhancements in executive functions and quality of life in the active stimulation group. The findings from this project could support the development of broader therapeutic approaches for other conditions in which behavioral disorders and emotional processing deficits affect patients and their caregivers.

KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population. Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions. The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.