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Behavioural Intervention
Mindfulness-Based Neurofeedback for Depression (mbNF Trial)
N/A
Recruiting
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-month
Awards & highlights
No Placebo-Only Group
Summary
This trial uses real-time brain scans to help depressed adolescents practice mindfulness and control their brain activity. It targets teens with major depression who don't respond well to current treatments. By seeing their brain activity live, they can reduce negative thinking patterns that worsen depression.
Who is the study for?
This trial is for adolescents aged 13-18 with major depressive disorder (MDD) who can give informed consent and have parental permission if under 18. Participants must speak English fluently and be in at least the third stage of puberty. Those with an IQ below 80, severe mental health disorders, recent substance abuse, or conditions that make MRI scans unsafe cannot join.
What is being tested?
The study tests a new treatment combining mindfulness practices with real-time feedback from fMRI brain scans to target rumination—a repetitive focus on negative thoughts—in depressed teens. The goal is to see if this approach changes brain activity related to rumination and improves depression symptoms.
What are the potential side effects?
Since the intervention involves mindfulness exercises and non-invasive brain imaging, there are minimal expected side effects. However, some participants might experience discomfort during the MRI scan or find focusing on their thoughts during mindfulness practice challenging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Within-person Default Mode Network (DMN) Connectivity
Secondary study objectives
Interviewer-Assessed Depression Symptoms
Mental Depression
Self-Reported Rumination
Other study objectives
Default Mode Network (DMN) and Frontoparietal Control Network (FPCN) Connectivity
Ecological Momentary Assessment of Depression Symptoms
Ecological Momentary Assessment of Mindfulness
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: 15-Minute mbNFActive Control1 Intervention
Participants receiving mindfulness training and 15-minute session of mbNF
Group II: 30-Minute mbNFActive Control1 Intervention
Participants receiving mindfulness training and 30-minute session of mbNF
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression, such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), work by altering thought patterns and increasing awareness to reduce negative thinking and improve emotional regulation. Electroconvulsive therapy (ECT) involves electrical stimulation of the brain to induce changes in brain chemistry that can rapidly alleviate severe depressive symptoms.
The trial on mindfulness-based real-time fMRI neurofeedback aims to modify brain circuits associated with rumination, a key factor in depression, by providing real-time feedback to help patients regulate their brain activity. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and sets realistic expectations for outcomes.
Treatment of Psychiatric Problems After Traumatic Brain Injury.Can magnetic resonance imaging enhance the assessment of potential new treatments for cognitive impairment in mood disorders? A systematic review and position paper by the International Society for Bipolar Disorders Targeting Cognition Task Force.Biomarkers for Deep Brain Stimulation in Animal Models of Depression.
Treatment of Psychiatric Problems After Traumatic Brain Injury.Can magnetic resonance imaging enhance the assessment of potential new treatments for cognitive impairment in mood disorders? A systematic review and position paper by the International Society for Bipolar Disorders Targeting Cognition Task Force.Biomarkers for Deep Brain Stimulation in Animal Models of Depression.
Find a Location
Who is running the clinical trial?
Northeastern UniversityOTHER
98 Previous Clinical Trials
70,906 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,162 Total Patients Enrolled
1 Trials studying Rumination Syndrome
62 Patients Enrolled for Rumination Syndrome
National Institute of Mental Health (NIMH)NIH
2,915 Previous Clinical Trials
2,738,665 Total Patients Enrolled
1 Trials studying Rumination Syndrome
183 Patients Enrolled for Rumination Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for mental health that is not an antidepressant.I have a history of seizures.I have a severe medical or neurological condition, like a serious head injury.I am between 13 and 18 years old.I have been diagnosed with major depressive disorder.I have never been diagnosed with a major mental health disorder like schizophrenia, bipolar, or autism.I have given my consent, or if under 18, I and my guardian have consented.I am in or past the middle stages of puberty.
Research Study Groups:
This trial has the following groups:- Group 1: 15-Minute mbNF
- Group 2: 30-Minute mbNF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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