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

ClinicalTrials.gov IDNCT07041073

PhaseNA

Enrollment72

SponsorCorporacion Parc Tauli

Age18 Years

SexALL

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Conditions studied

Major Depression With Comorbid Anxiety Symptoms, Major Depressive Disorder (MDD)

About this study

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.

Interventions

Device: Active swLORETA Z-score Neurofeedback — Participants receive 10 sessions (25 minutes each, twice per week for 5 weeks) of EEG-based neurofeedback using the NeuroGuide® software and a 24-channel EEG recording system (eego™, ANT Neuro). The neurofeedback protocol is based on real-time swLORETA Z-score training targeting brain regions involved in emotion regulation. Feedback is provided via gamified visual displays when EEG activity moves toward normative patterns. This is an operant conditioning-based protocol designed to enhance emotional self-regulation.
Device: Yoked-sham swLORETA Z-score Neurofeedback — Participants receive 10 sessions identical in appearance and duration to the active neurofeedback condition. However, the feedback provided is not based on their own EEG activity. Instead, it is pre-recorded data from a matched participant in the active group ("yoked" design), ensuring no real-time neurophysiological modulation occurs. The same EEG equipment and visual feedback interface are used to maintain blinding.

Primary outcomes

Change in depressive symptom severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to post-intervention. (From enrollment (week 0) to the end of treatment (week 6))
Change in depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D), from baseline to post-treatment (From enrollment (week 0) to the end of treatment (week 6))
Change in self-reported anxiety symptoms measured by the Beck Anxiety Inventory (BAI), from baseline to post-intervention (From enrollment (week 0) to the end of treatment (week 6))
Change in self-reported depressive symptoms measured by the Beck Depression Inventory-II (BDI-II), from baseline to post-intervention (From enrollment (week 0) to the end of treatment (week 6))
Change in salivary cortisol levels (Cortisol Awakening Response and Diurnal Slope) (From enrollment (week 0) to the end of treatment (week 6))
Change in cognitive emotion regulation strategies measured by the Cognitive Emotion Regulation Questionnaire (CERQ) (From enrollment (week 0) to the end of treatment (week 6))
Change in transient mood states measured by the Profile of Mood States (POMS) (Before and after each neurofeedback session (Sessions 1-10; Weeks 1-5))
Change in resting-state EEG activity (From baseline (week 0) to Post-treatment (Week 6); Before and after each neurofeedback session (Sessions 1-10; Weeks 1-5))

Eligibility information

Inclusion Criteria: * A primary diagnosis of Major Depressive Disorder (MDD), established by qualified psychiatrists according to DSM-5 criteria. * Patients with comorbid anxiety or anxiety symptoms will be included, provided that MDD is the primary diagnosis. * Participants must score at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS), indicating a moderate level of depression. * All participants must be on a stable psychopharmacological treatment for at least 6 weeks before beginning of the study. Exclusion Criteria: * Patients with a concurrent diagnosis of MDD and other severe psychiatric disorders. * Patients with serious physical illnesses that could interfere with study participation or the interpretation of results. * Participants currently undergoing structured psychotherapy or other interventions unrelated to standard psychopharmacological treatment. * Patients presenting with active suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), at the time of screening will not be eligible due to associated risks. * Active substance abuse or dependence (except nicotine). * Intellectual disability or conditions that interfere with the ability to provide informed consent and complete the intervention (e.g., severe visual or hearing impairments). * Pregnancy.

Study locations

Corporació Sanitària Parc Taulí de Sabadell, Sabadell, Barcelona, Cataluña 08208 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.