NCT04752072 - 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)

Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P
The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
Cloitre, M
, Karatzias, T., Mc Glanaghy, E. (2019). Enhanced STAIR Narrative Therapy for CPTSD. Treatment Manual. Unpublished Manuscript.
Gray MJ, Litz BT, Hsu JL, Lombardo TW
Psychometric properties of the life events checklist. Assessment. 2004 Dec;11(4):330-41.
Hutton P, Byrne R, Pyle M, Morrison AP
Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.
Kroenke K, Spitzer RL, Williams JB
The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66.
Kroenke K, Spitzer RL, Williams JB
The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M
Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804.
Spitzer RL, Kroenke K, Williams JB, Löwe B
A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) vs. Treatment as Usual (TAU) for Complex Posttraumatic Stress Disorder (CPTSD) in Military Personnel

Details for clinical trial NCT04752072

Clinical trial NCT04752072 - References