NCT06358339 - 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)

Christensen H, Farrer L, Batterham PJ, Mackinnon A, Griffiths KM, Donker T
The effect of a web-based depression intervention on suicide ideation: secondary outcome from a randomised controlled trial in a helpline. BMJ Open. 2013 Jun 28;3(6):e002886. doi: 10.1136/bmjopen-2013-002886.
Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC
The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011 Apr;41(2):208-26. doi: 10.1007/s12160-010-9253-x.
Collins LM, Murphy SA, Nair VN, Strecher VJ
A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med. 2005 Aug;30(1):65-73. doi: 10.1207/s15324796abm3001_8.
Deci EL, Ryan RM, Handbook of self-determination research[M/OL]
Rochester, NY: University Rochester Press, 2002. https://psycnet.apa.org/record/2002-01702-000.
Hopia H, Raitio K
Gamification in Healthcare: Perspectives of Mental Health Service Users and Health Professionals. Issues Ment Health Nurs. 2016 Dec;37(12):894-902. doi: 10.1080/01612840.2016.1233595. Epub 2016 Dec 1.
Morris ZS, Wooding S, Grant J
The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
Sebastian Deterding, Dan Dixon, Rilla Khaled, and Lennart Nacke
2011. From game design elements to gamefulness: defining

The Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS) : Implementing a Gamified mHealth Intervention to Reduce Post-Discharge Suicide Risk in Patients With Mental Disorders Using Multiphase Optimization Strategy (MOST)

Details for clinical trial NCT06358339

Clinical trial NCT06358339 - References