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EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial

Study acronym: RESoNATE
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 27, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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The goal of this clinical trial is to evaluate whether EEG-based neurofeedback targeting the emotion regulation network through swLORETA can improve emotional regulation and reduce symptoms in adults with Major Depressive Disorder (MDD) who have not responded sufficiently to first-line treatments. The main questions it aims to answer are: * Does EEG-neurofeedback improve emotional self-regulation and reduce clinical symptoms in patients with MDD with or without anxiety symptoms? * Are changes in EEG resting-state activity and stress biomarkers (e.g., cortisol) associated with clinical improvement? Researchers will compare an active neurofeedback group, a sham (placebo) neurofeedback group, and a treatment-as-usual control group to see if real-time EEG-neurofeedback leads to greater improvement in mood, emotional regulation, and neurophysiological indicators than placebo or no additional intervention. Participants will: * Receive 10 sessions of either real or sham EEG-neurofeedback (or no sessions in the control group) over 5 weeks. * Complete clinical, psychological, and neurophysiological assessments before (week 0) and after the intervention (week 6). * Provide repeated saliva samples to assess stress-related biomarkers at week 0 and week 6. * Continue their standard pharmacological treatment throughout the study.
Trial Details
NCT Number NCT07041073
Lead Sponsor Corporacion Parc Tauli
Collaborators: Horizon 2020 - European Commission
Conditions
(from sponsor)
Major Depression With Comorbid Anxiety Symptoms, Major Depressive Disorder (MDD)
Related terms Anxiety Disorders, Depression, Emotional Regulation, Major Depressive Disorder
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov