Design and rational 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
This novel treatment strategy could pave the way for a more personalized and targeted treatment for those with depression & childhood trauma.
Article Abstract
“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.”
—Description from publisher
Article Access
Open Access
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 rational 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, 23(41). Open access: https://doi.org/10.1186/s12888-023-04518-0
Date
January 17, 2023
Creator(s)
Anouk W. Gathier, Josine E. Verhoeven, Patricia C. van Oppen
Contributor(s)
Brenda W. J. H. Penninx, Maarten J. M. Merkx, Pieter Dingemanse, Kim M. K. S. Stehouwer, Carmen M. M. van den Bulck, Christiaan H. Vinkers
Topics
Childhood Trauma, Depression
Practice & Methods
Comparative Studies, Protocols
Extent
14 pages
Publisher
BMC Psychiatry
Rights
© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
APA Citation
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 rational 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, 23(41). Open access: https://doi.org/10.1186/s12888-023-04518-0
Audience
EMDR Therapists, Other Mental Health Professionals
Language
English
Content Type
Article, Peer-Reviewed, RCT
Access Type
External Resource, Open Access
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