Tests EEG brain-training neurofeedback for emotion regulation in adults with depression
Tests brain-wave neurofeedback against sham and usual care in adults with depression.
Plain-language title generated from the registry record
Registry title: EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial
Key facts
- Where
- Sabadell, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07041073, who can take part
Where in Spain
- Corporació Sanitària Parc Taulí de SabadellSabadell, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Corporacion Parc Tauli
- Trial code
- NCT07041073
- Record updated
- 27 June 2025
- Original description
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:Read full original descriptionShow less
Restoring Emotional Stability Through Neurofeedback and AI for Transformative Empowerment
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.
Inclusion: 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: 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; Intellectual disability or conditions that interfere with the ability to provide informed consent and complete the intervention (e.g., severe visual or hearing impairments); 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); Pregnancy.