NCT07041073 EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial
| NCT ID | NCT07041073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corporacion Parc Tauli |
| Condition | Major Depression With Comorbid Anxiety Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-05-19 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07041073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depression With Comorbid Anxiety Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07041073 currently recruiting?
Yes, NCT07041073 is actively recruiting participants. Contact the research team at vsoria@gmail.com for enrollment information.
Where is the NCT07041073 trial being conducted?
This trial is being conducted at Sabadell, Spain.
Who is sponsoring the NCT07041073 clinical trial?
NCT07041073 is sponsored by Corporacion Parc Tauli. The trial plans to enroll 72 participants.
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