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

• Published in: BMC psychiatry 2023-01, Vol.23 (1), p.41-41, Article 41
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adult; Adverse Childhood Experiences; Affect; Childhood Trauma; Depressive Disorder, Major - psychology; Depressive Disorder, Major - therapy; Eye Movement Desensitization and Reprocessing; Humans; Imagery Rescripting; Major Depressive Disorder; Psychotherapy - methods; Randomized Controlled Trial; Single-Blind Method; Trauma-Focused Therapy; Treatment Outcome
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-023-04518-0

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. 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). 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. ClinicalTrials.gov, registered at 08-12-2021, number of identification: NCT05149352.