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

Launched by CORPORACION PARC TAULI · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a type of brain training called EEG-based neurofeedback can help adults with Major Depressive Disorder (MDD) better manage their emotions and reduce symptoms of depression, especially for those who haven’t fully improved with standard treatments like medication. The study also looks at whether changes in brain activity and stress levels, measured through saliva tests, are linked to feeling better. Participants will be divided into three groups: one receiving real neurofeedback, one receiving a fake (placebo) version, and one continuing their usual treatment without additional sessions.

People eligible for this study are adults diagnosed with moderate depression, with or without anxiety symptoms, who have been on stable medication for at least six weeks. Participants will attend 10 neurofeedback sessions over five weeks or continue their usual care if in the control group. They will complete assessments before and after the sessions, including mood evaluations and saliva tests to check stress hormones. Importantly, those with severe psychiatric conditions, active suicidal thoughts, ongoing psychotherapy, substance abuse issues, or certain health conditions won’t be able to join. This study aims to find out if this brain training can be a helpful addition to current treatments for depression.

Gender

ALL

Eligibility criteria

• 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.