Design and rationale of the REStoring mood after early life trauma with psychotherapy (RESET-psychotherapy) study

Autor: Gathier, Anouk W., Verhoeven, Josine E., van Oppen, Patricia C., Penninx, Brenda W. J. H., Merkx, Maarten J. M., Dingemanse, Pieter, Stehouwer, Kim M. K. S., van den Bulck, Carmen M. M., Vinkers, Christiaan H.
Přispěvatelé: Psychiatry, APH - Mental Health, APH - Digital Health, Amsterdam Neuroscience - Complex Trait Genetics, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMC Psychiatry, 23(1):41. BioMed Central
Gathier, A W, Verhoeven, J E, van Oppen, P C, Penninx, B W J H, Merkx, M J M, Dingemanse, P, Stehouwer, K M K S, van den Bulck, C M M & Vinkers, C H 2023, ' Design and rationale of the REStoring mood after early life trauma with psychotherapy (RESET-psychotherapy) study : a multicenter randomized controlled trial on the efficacy of adjunctive trauma-focused therapy (TFT) versus treatment as usual (TAU) for adult patients with major depressive disorder (MDD) and childhood trauma ', BMC Psychiatry, vol. 23, no. 1, 41 . https://doi.org/10.1186/s12888-023-04518-0
ISSN: 1471-244X
DOI: 10.1186/s12888-023-04518-0
Popis: Background Major depressive disorder (MDD) is a common, recurrent mental disorder and a leading cause of disability worldwide. A large part of adult MDD patients report a history of childhood trauma (CT). Patients with MDD and CT are assumed to represent a clinically and neurobiologically distinct MDD subtype with an earlier onset, unfavorable disease course, stress systems’ dysregulations and brain alterations. Currently, there is no evidence-based treatment strategy for MDD that specifically targets CT. Given the central role of trauma in MDD patients with CT, trauma-focused therapy (TFT), adjunctive to treatment as usual (TAU), may be efficacious to alleviate depressive symptoms in this patient population. Methods The RESET-psychotherapy study is a 12-week, single-blind, randomized controlled trial testing the efficacy of TFT in 158 adults with moderate to severe MDD, as a ‘stand-alone’ depression diagnosis or superimposed on a persistent depressive disorder (PDD), and CT. TFT (6–10 sessions of Eye Movement Desensitization and Reprocessing and/or imagery rescripting) + TAU is compared to TAU only. Assessments, including a wide range of psychological/psychiatric and biological characteristics, take place before randomization (T0), during treatment (T1), at post-treatment (T2) and at 6-month follow-up (T3). Pre-post treatment stress-related biomarkers in hair (cortisol) and blood (epigenetics and inflammation) will be assessed to better understand working mechanisms of TFT. A subgroup of 60 participants will undergo structural and functional Magnetic Resonance Imaging (MRI) assessments to determine pre-post treatment brain activity. The primary outcome is self-reported depression symptom severity at post-treatment, measured with the 30-item Inventory of Depressive Symptomatology – Self Report (IDS-SR). Discussion If adjunctive TFT efficaciously alleviates depressive symptoms in MDD patients with CT, this novel treatment strategy could pave the way for a more personalized and targeted MDD treatment. Trial registration ClinicalTrials.gov, registered at 08–12-2021, number of identification: NCT05149352.
Databáze: OpenAIRE
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