Efficacy of Ego State Therapy Versus Eye Movement Desensitisation and Reprocessing in Major Depressive Disorder with Childhood Trauma: Interim Analysis of a Randomised Single-Blind Active Controlled Non-Inferiority Clinical Trial

Background: Around 60% of patients with major depressive disorder (MDD) report adverse childhood circumstances. Such adversities have been shown to be an important factor in the development and maintenance of depression. For this reason, specific therapies would be required to treat patients with MDD and emotional childhood adversities. We aimed to investigate the clinical outcomes of ego state therapy (EST) compared with eye movement desensitisation and reprocessing (EMDR), a therapy already established for MDD. Methods: In the single-blind, randomised, active controlled, feasibility trial, patients with MDD, aged 18-75 years, were allocated 1:1 to trauma-focused therapies EMDR or EST. Participants underwent 14 sessions of psychotherapy. The primary outcome was the change in depression severity assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary clinical outcomes included response, remission from depression, posttraumatic stress disorder (PTSD) symptoms, emotion regulation and aggression. Findings: 40 participants were included. Both EMDR and EST significantly decreased depression symptom scores with a large effect size (F (2/114) = 9·908, p=0·0001, Cohen’s f = 0·417). No significant difference between treatment groups (F (1/114) = 0·407, p = 0·525) and no significant interactive effect between visits and treatment groups (F (2/114) = 0·08, p = 0·924) were detected. Secondary outcomes BDI-II scores and PTSD symptoms also significantly decreased over time. There was no significant effects on aggression scores, self-regulation, and adaptive and maladaptive cognitive and emotional regulation. No adverse events of special interest were reported. Interpretation: EST was not inferior to the well-established EMDR, supporting its potential in MDD with childhood adversity. Both therapy programmes not only show effects on depressive symptoms, but also on PTSD symptoms. The trial provides important information about the feasibility including efficacy and the sample size required for a confirmatory regulatory trial.