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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
mbNF Trial Summary
This trial aims to find out if a mindfulness-based intervention can reduce depression in adolescents by changing the brain circuit related to rumination.
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.Check my eligibility
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.See study design
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.
mbNF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Within-person Default Mode Network (DMN) Connectivity
Secondary outcome measures
Interviewer-Assessed Depression Symptoms
Mental Depression
Self-Reported Rumination
Other outcome measures
Default Mode Network (DMN) and Frontoparietal Control Network (FPCN) Connectivity
Ecological Momentary Assessment of Depression Symptoms
Ecological Momentary Assessment of Mindfulness
+1 morembNF 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
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Who is running the clinical trial?
Northeastern UniversityOTHER
88 Previous Clinical Trials
61,220 Total Patients Enrolled
3 Trials studying Depression
144 Patients Enrolled for Depression
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,169 Total Patients Enrolled
47 Trials studying Depression
38,113 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,619 Total Patients Enrolled
666 Trials studying Depression
251,494 Patients Enrolled for Depression
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any particular demographics that are particularly suited for this clinical experiment?
"Eligibility criteria for this research include having depression and being between the ages of 13 and 18. The study is in search of 90 participants to participate fully."
Answered by AI
Does this research project allow for the enrollment of senior citizens?
"Applicants aged 13 to 18 that meet the eligibility requirements for this clinical trial are welcome to apply. Currently, 209 studies exist for individuals younger than 18 and 988 trials target those over 65."
Answered by AI
Are there any openings at this point for those interested in participating in the clinical trial?
"According to clinicaltrials.gov, this research study is not actively recruiting participants at the present moment. The trial was first advertised on August 1st 2023 and amended July 2nd 2023; however, there are 1341 other medical trials that are currently enrolling patients."
Answered by AI
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