NCT04978194 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Charbonnier E, Trémolière B, Baussard L, Goncalves A, Lespiau F, Philippe AG, Le Vigouroux S
Effects of an online self-help intervention on university students' mental health during COVID-19: a non-randomized controlled pilot study. JMIR Preprints. 09/04/2021:29505
Charbonnier, E
, Le Vigouroux, S., & Goncalves, A. (2021). Etudiants en temps de confinement et au-delà. La Presse Médicale Formation. https://doi.org/10.1016/j.lpmfor.2021.06.011
Le Vigouroux S, Goncalves A, Charbonnier E
The Psychological Vulnerability of French University Students to the COVID-19 Confinement. Health Educ Behav. 2021 Apr;48(2):123-131. doi: 10.1177/1090198120987128. Epub 2021 Jan 20.

Effects of an Intervention on University Students' Mental Health and Learning During COVID-19: a Non-randomized Controlled Study

Clinical trial NCT04978194 - References