Researchers in an ongoing study hope to show that if adjunctive trauma-focused therapy (TFT) alleviates depressive symptoms among patients with major depressive disorder (MDD) and childhood trauma (CT) efficaciously, it may lead to more personalized and targeted MDD treatment, according to a pre-study report published in BMC Psychiatry.
Researchers seek to evaluate whether TFT adjunctive to treatment as usual (TAU) leads to a greater reduction of depressive symptoms posttreatment vs TAU exclusively in patients with MDD with CT. The primary endpoint is self-reported depression symptom severity at posttreatment.
Researchers are conducting the ongoing RESET-psychotherapy study (ClinicalTrials.gov Identifier: NCT05149352), a 12-week single-blind, randomly assigned controlled trial (RCT) to test the efficacy of TFT. Participants are recruited in the Netherlands from mental health organization sites. This will be a superiority RCT with dual treatment arms (TAU; TAU + TFT). They plan to include 158 adults with MDD and CT who will be randomly allocated (1:1) to 1 of the treatment arms. Researchers will invite a subgroup (n=30 in each arm) to participate in a functional magnetic resonance imaging (fMRI) sub-study to assess pre/posttreatment brain activity.
Significant inclusion criteria include being at least 18 years of age, a primary diagnosis of MDD (stand-alone depression diagnosis or superimposed on a persistent depressive disorder) confirmed with the Mini International Neuropsychiatric Interview — Simplified (MINI-S) for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), a score of at least 26 (moderate to severe MDD) on the Inventory of Depressive Symptomatology — Self Report (IDS-SR), moderate to severe CT validated by appropriate scores on the short form of the Childhood Trauma Questionnaire (CTQ-SF), and adequate mastery of Dutch.
Telephone screening for exclusion criteria include a primary diagnosis of posttraumatic stress disorder or acute stress disorder, lifetime diagnosis of borderline personality disorder (BPD), current substance use dependence, comorbid diagnosis of severe mental disorder, or previously having received TFT aimed at CT. The fMRI sub-study additionally excludes major internal or neurologic disorders, pregnancy, claustrophobia, and known contra indications for MRI.
Participants will be assessed before being randomly assigned (T0), during treatment (T1), posttreatment (T2), and at 6-month follow-up (T3). Participants will receive a €25 gift voucher for each completed assessment. TFT treatment includes 6 to 10, 60 to 90- minute individual TFT sessions of eye movement desensitization and reprocessing and/or imagery rescripting. Therapists providing TFT will not provide TAU for the same patient. Participants in the TFT treatment plus TAU will be compared with participants in TAU only. The nature of TFT demands patients and therapists are aware of allocated treatment. Outcome assessors will be blinded to the allocation.
The primary endpoint will be assessed with the 30-item IDS-SR which measures the severity of depressive symptomology during the previous 7 days. Remission and depression symptom severity at follow-up and during treatment represent secondary outcomes. A shortened version of the clinician-administered Columbia-Suicide Severity Rating Scale will be administered in the event of participants reporting suicidal ideation, intentions, or plans.
At T0 and T2 hair samples close to scalp will be collected and assessed as a stable retrospective marker of long-term systemic cortisol levels. Blood samples will be taken at T0 and T2 for analysis on epigenetic and inflammatory markers (C-reactive protein, tumor necrosis factor-alpha, interleukin-6) underlying the effects of TFT.
Study limitations include participants in the study group will receive more treatment sessions than those in the TAU group, telephone screening being unreliable for determining exclusion criteria, and CT only being assessed by a retrospective self-report measure.
Researchers hope to conclude, “If adjunctive TFT would be more efficacious than TAU only, this would be a novel hypothesis-driven treatment strategy for an important MDD subtype and pave the way for a more personalized and targeted MDD treatment.”
This article originally appeared on Psychiatry Advisor
Gathier AW, Verhoeven JE, van Oppen PC, et al. 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. Published online January 17, 2023. doi:10.1186/s12888-023-04518-0