NCT03213327 - 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)

Damásio BF, Valentini F, Núñes-Rodriguez SI, Kliem S, Koller SH, Hinz A, Brähler E, Finck C, Zenger M
Is the General Self-Efficacy Scale a Reliable Measure to be used in Cross-Cultural Studies? Results from Brazil, Germany and Colombia. Span J Psychol. 2016 May 26;19:E29. doi: 10.1017/sjp.2016.30.
Derogatis LR, Melisaratos N
The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
Jenny GJ, Bauer GF, Vinje HF, Vogt K, Torp S
The Application of Salutogenesis to Work. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindström B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK435821/

StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks

Clinical trial NCT03213327 - References