NCT03518411 - 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)

Bentley KH, Boettcher H, Bullis JR, Carl JR, Conklin LR, Sauer-Zavala S, Pierre-Louis C, Farchione TJ, Barlow DH
Development of a Single-Session, Transdiagnostic Preventive Intervention for Young Adults at Risk for Emotional Disorders. Behav Modif. 2017
Fisak BJ Jr, Richard D, Mann A
The prevention of child and adolescent anxiety: a meta-analytic review. Prev Sci. 2011 Sep;12(3):255-68. doi: 10.1007/s11121-011-0210-0. Review.
Goebert D, Thompson D, Takeshita J, Beach C, Bryson P, Ephgrave K, Kent A, Kunkel M, Schechter J, Tate J
Depressive symptoms in medical students and residents: a multischool study. Acad Med. 2009 Feb;84(2):236-41. doi: 10.1097/ACM.0b013e31819391bb.
Guille C, Zhao Z, Krystal J, Nichols B, Brady K, Sen S
Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1192-8. doi: 10.1001/jamapsychiatry.2015.1880.
Rotenstein LS, Ramos MA, Torre M, Segal JB, Peluso MJ, Guille C, Sen S, Mata DA
Prevalence of Depression, Depressive Symptoms, and Suicidal Ideation Among Medical Students: A Systematic Review and Meta-Analysis. JAMA. 2016 Dec 6;316(21):2214-2236. doi: 10.1001/jama.2016.17324. Review.

Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese: Open Clinical Trial

Clinical trial NCT03518411 - References