Actively Recruiting
A Randomised Controlled Trial of FMRI-neurofeedback Combined with Standard Care in Depression
Led by Maastricht University Medical Center · Updated on 2025-03-24
120
Participants Needed
3
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the use of fMRI-neurofeedback combined with standard care compared to standard care alone in adults with depression. Previous studies suggest this approach has a good safety profile and may reduce symptoms, but a direct comparison has not yet been made. This trial aims to assess the impact of adding fMRI-neurofeedback on depressive symptom severity. Participants will be randomly assigned to receive either standard care or standard care plus fMRI-neurofeedback training. The neurofeedback group will undergo five sessions, each about one hour long, including visual stimulation to identify brain areas linked to positive emotions and about 30 minutes of training to increase activity in these areas using real-time fMRI signals. Assessments occur before, immediately after, and six months following the intervention. During the study, participants will have their depression severity measured using the Inventory of Depressive Symptomatology and other mental health scales. Researchers will evaluate symptoms at baseline, post-intervention, and six-month follow-up. The study also monitors brain activity changes via fMRI in the neurofeedback group. The total participation period spans approximately six months, including follow-up evaluations to understand longer-term effects.
CONDITIONS
Brief Title
FMRI-neurofeedback in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a depressive disorder (ICD-10: F32 or F33)
- Stable antidepressant medication for at least 4 weeks
- Current depression with QIDS score of 17 or higher (or 13 if needed for recruitment)
- Adults aged 18 years or older
You will not qualify if you...
- MRI contraindications such as cardiac pacemaker or certain metallic implants
- History of psychotic disorder, bipolar disorder, or psychotic depression
- Current use of illegal drugs in the last four weeks
- Excessive alcohol use interfering with daily functioning
- History of neurological diseases affecting fMRI signal or brain anatomy (e.g. stroke, multiple sclerosis, brain tumour)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive fMRI-neurofeedback training combined with standard care or continue with standard care alone. The neurofeedback involves 5 sessions of about 1 hour each, including brain area localization and upregulation training.
5 sessions of about 1 hour each
Duration - 6 months
Participants are monitored for symptoms of depression and mental health status 6 months after the intervention using various assessment scales.
1 follow-up visit
Trial Site Locations
Total: 3 locations
1
Mondriaan Zorggroep
Maastricht, Netherlands, 6226NB
Actively Recruiting
2
Maastricht University
Maastricht, Netherlands, 6229ER
Actively Recruiting
3
Maastricht UMC+
Maastricht, Netherlands, 6229HX
Actively Recruiting
Research Team
D
David E Linden, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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