Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents.
Paul A Bloom, David Pagliaccio, Jiahe Zhang...
https://pubmed.ncbi.nlm.nih.gov/37848857/Actively Recruiting
Led by Columbia University · Updated on 2026-04-29
90
Participants Needed
2
Research Sites
21 weeks
Total Duration
This research aims to evaluate a new mindfulness-based real-time fMRI neurofeedback intervention for adolescents aged 13 to 18 years diagnosed with major depressive disorder MDD. Depression is common in this age group and current treatments only help about half of patients. The study focuses on rumination, a pattern of repetitive negative thinking linked to depression onset and treatment resistance, by targeting brain activity related to this process. Participants will first receive about 45 minutes of mindfulness training outside the MRI scanner. Then they will undergo one session of mindfulness-based fMRI neurofeedback mbNF, where they observe their brain activity and practice mindfulness to reduce overactivity in a brain network called the default mode network DMN. The study compares two groups receiving different mbNF session lengths 15 minutes or 30 minutes. During the study, researchers will measure changes in brain connectivity before and after mbNF sessions using fMRI. Depression symptoms and rumination will be assessed using clinician interviews, self-reports, and smartphone-based questionnaires at baseline, immediately after treatment, and one month later. The study monitors participant safety and evaluates whether mbNF reduces rumination and depressive symptoms. Participation lasts through these assessments up to one month post-treatment.
CONDITIONS
Mindfulness-Based fMRI Neurofeedback for Depression
R
Randy P Auerbach, PhD
S
Simryn Molina, BA
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Columbia University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 15-Minute Mindfulness-Based fMRI Neurofeedback | 30-Minute Mindfulness-Based fMRI Neurofeedback |
|---|---|---|
| What it is | A single session of mindfulness-based fMRI neurofeedback lasting 15 minutes, following 45 minutes of mindfulness training. The neurofeedback targets specific brain networks related to depression. | A single session of mindfulness-based fMRI neurofeedback lasting 30 minutes, following 45 minutes of mindfulness training. The neurofeedback targets the same brain networks as the 15-minute arm. |
| Role in trial | Investigational dosing arm evaluating the effects of a shorter neurofeedback session on depressive symptoms and rumination. | Investigational dosing arm evaluating the effects of a longer neurofeedback session on depressive symptoms and rumination. |
| Primary use | Studied to determine whether a shorter neurofeedback session can impact symptoms of depression and rumination in adolescents. | Studied to determine whether a longer neurofeedback session can impact symptoms of depression and rumination in adolescents. |
| How it is given or performed | Participants first receive mindfulness training, then undergo real-time fMRI neurofeedback for 15 minutes, targeting default mode and frontoparietal control networks. | Same procedure as the 15-minute group, but neurofeedback lasts for 30 minutes instead of 15. |
| Evidence status | Ongoing randomized investigation; no published results yet for this dosing configuration in the current trial. Earlier randomized data for similar mbNF procedures in adolescents suggest measurable effects on depressive symptoms, but optimal dosing remains under study. | Ongoing randomized investigation; no published results yet for this dosing configuration in the current trial. Prior trials demonstrate mbNF can impact depressive symptoms in adolescents, but whether a longer session produces greater improvement is not yet established. |
| Important limitations | Effects on symptoms may differ from longer neurofeedback sessions. The optimal session length for adolescent depression is not yet established. | Longer sessions may require greater patient tolerance and may not yield proportionally greater benefit. The effect of session duration is still uncertain in this population. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session on treatment day
Participants receive 45 minutes of mindfulness training followed by either a 15- or 30-minute mindfulness-based real-time fMRI neurofeedback session targeting brain networks associated with depression.
1 visit (in-person) for mindfulness training and neurofeedback
Duration - 1 month
Participants complete clinician assessments, self-reports, and smartphone-based assessments to monitor changes in depression symptoms and rumination after treatment.
1 follow-up visit plus ongoing smartphone assessments
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Paul A Bloom, David Pagliaccio, Jiahe Zhang...
https://pubmed.ncbi.nlm.nih.gov/37848857/Columbia University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor