NCT05390034 - 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)

Aldao A, Nolen-Hoeksema S, Schweizer S
Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
Aldao A, Nolen-Hoeksema S
The influence of context on the implementation of adaptive emotion regulation strategies. Behav Res Ther. 2012 Aug;50(7-8):493-501. doi: 10.1016/j.brat.2012.04.004. Epub 2012 May 7.
Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W
Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019.
Csikszentmihalyi M, Larson R
Validity and reliability of the Experience-Sampling Method. J Nerv Ment Dis. 1987 Sep;175(9):526-36.
Gross JJ
Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. Review.
Kazdin AE
Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. Review.

REFLEX: A Randomized Controlled Trial to Test the Efficacy of an Emotion Regulation Flexibility Program With Daily Measures

Clinical trial NCT05390034 - References