EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCorporacion Parc Tauli
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Active swLORETA Z-score Neurofeedback
- Yoked-sham swLORETA Z-score Neurofeedback
Treatment groups
72 Participants
are divided into 3 treatment groupsSponsors and collaborators
Corporacion Parc Tauli
Lead sponsor
Horizon 2020 - European Commission
Collaborator
Source ClinicalTrials.gov