Depression in AdolescencembNFNCT05617495
Mindfulness-Based fMRI Neurofeedback for Depression
A study testing Mindfulness + fMRI Neurofeedback in people with Depression in Adolescence and Rumination, run by Columbia University at 2 sites in United States.
Trial summary
In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression in Adolescence, Rumination
- What is being tested?
- Mindfulness + fMRI Neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 13-18 years-old
- Written informed assent/consent and parental/guardian permission for 13-17 year-olds or informed consent for 18 year-olds
- Tanner puberty stage ≥3
- Meets current diagnostic criteria for MDD
- English fluency
Who cannot join
- Lifetime history of primary psychotic disorders, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorders
- Substance use disorder, moderate or severe in past 6 months
- Active suicidal ideation with a specific plan
- History of seizure disorder
- Medical or neurological illness (e.g., severe head injury)
- MRI contraindications
- Current psychotropic medication use other than antidepressant medication
- Intelligence quotient (IQ) <80.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Simryn Molina, BA contact
United States2 sites, 2 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Susan Whitfield-Gabrieli, PhD, s.whitfield-gabrieli@northeastern.edu
Susan Whitfield-Gabrieli, PhD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Randy P Auerbach, PhD, 646-774-5745, rpa2009@cumc.columbia.edu
Randy P Auerbach
About this study
Official title: Targeting Adolescent Depression Symptoms Using Network-based Real-time fMRI Neurofeedback and Mindfulness Meditation (NIMH); Mindfulness-Based Real-Time fMRI Neurofeedback for Depression (IRB)
In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response. Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.
Read the detailed description
Adolescent major depressive disorder (MDD) is common and debilitating. Presently, gold-standard treatments are only effective for approximately half of patients, underscoring the need to develop novel interventions, particularly to target core underlying mechanisms and more effectively treat this recurrent disorder.
Rumination, the tendency to perseverate about depressive symptoms, contributes to MDD onset and predicts treatment non-response and relapse. At the neural level, rumination is characterized by elevated functional connectivity within the default mode network (DMN), and similarly, prior research has consistently demonstrated patterns of DMN hyper-connectivity in MDD. Interestingly, mindfulness meditation, which trains attentional focus to the present moment, reduces perseverative thinking, ruminative tendencies, and depression symptoms. Further, prior research have shown that adolescents can apply mindfulness practices to decrease perceived stress, increase sustained attention, and suppress DMN activity. Although mindfulness has profound mental health benefits, for some, mindfulness alone may not be sufficient to mitigate ruminative tendencies during a depressive episode. That is, MDD symptoms, including reduced motivation, inattention, and lack of self-efficacy, may impede a patient's progress in successfully acquiring and utilizing mindfulness strategies necessary to change perceptions about one's environment and relationships. To directly address this challenge, this project will use real-time fMRI neurofeedback to enhance the acquisition and utilization of mindfulness skills to better target DMN hyper-connectivity, rumination, and depressive symptoms.
Specifically, a novel, mindfulness-based, real-time neurofeedback (mbNF) paradigm will be used whereby people observe a visual display of their brain activity and practice mindfulness to volitionally reduce DMN activation. Adolescents (N=90; ages 13-18 years) diagnosed with MDD will complete a ~45-minute mindfulness training outside the MRI scanner. To test target engagement of reducing DMN hyper-connectivity and dosing effects, adolescents will all receive mbNF and changes in brain connectivity will be examined (primary outcome). To examine dosing effects, adolescents will be randomized to receive either a 15- or a 30-minute mbNF session (n=45/dose group). Clinician-administered instruments, self-reports, and smartphone ecological momentary assessment will be used test whether mbNF contributes to a greater reduction in clinician assessed depression symptoms as well as decreased rumination post-treatment (secondary outcomes). As a whole, mbNF is directly in line with precision medicine initiatives, and if successful, could revolutionize clinical care for depressed adolescents.
- Conditions
- Depression in Adolescence, Rumination
- Being tested
- Mindfulness + fMRI Neurofeedback
- Keywords
- Real-time fMRI Neurofeedback, Mindfulness, Rumination, Major Depressive Disorder
- Medical subject headings
- Rumination Syndrome, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness + fMRI NeurofeedbackOther
Also called Mindfulness-based Real-time fMRI Neurofeedback
Prior to neurofeedback, participants will receive 45 minutes of mindfulness training. Participants will then receive mindfulness-based fMRI neurofeedback targeting the default mode network and frontoparietal control network.
| Study group | Role | What they receive |
|---|---|---|
| 15-Minute mbNF | Active comparator | Participants receiving mindfulness training and 15-minute session of mbNF Receives: Other: Mindfulness + fMRI Neurofeedback |
| 30-Minute mbNF | Active comparator | Participants receiving mindfulness training and 30-minute session of mbNF Receives: Other: Mindfulness + fMRI Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-person Default Mode Network (DMN) Connectivity
DMN change will be assessed via fMRI from before mbNF.
Measured: Pre-mbNF procedure
Within-person Default Mode Network (DMN) Connectivity
DMN connectivity will be assessed via fMRI from post mbNF. Changes in DMN connectivity following mbNF are anticipated.
Measured: Post-mbNF procedure
Secondary outcomes (8)
Self-Report Depression Symptoms
Self-report of depression symptoms from pre-mbNF assessed through the Mood and Feelings Questionnaire; 33-items with each item ranging from 0-2; Higher scores reflect greater depression
Measured: Pre-mbNF procedure
Self-Report Depression Symptoms
Self-report of depression symptoms from post-mbNF assessed through the Mood and Feelings Questionnaire; 33-items with each item ranging from 0-2; Higher scores reflect greater depression
Measured: Immediately Post-mbNF procedure
Self-Report Depression Symptoms
Self-report of depression symptoms from 1 month after mbNF assessed through the Mood and Feelings Questionnaire; 33-items with each item ranging from 0-2; Higher scores reflect greater depression
Measured: 1-month
Interviewer-Assessed Depression Symptoms
Depressive symptoms at baseline assessed via the Children's Depression Rating Scale - Revised, which is a clinician interview of depression symptoms. Scores range from 17 to 119 with higher scores reflecting greater depression symptom severity.
Measured: Baseline
Interviewer-Assessed Depression Symptoms
Depressive symptoms at 1-month post mbNF assessed via the Children's Depression Rating Scale - Revised, which is a clinician interview of depression symptoms. Scores range from 17 to 119 with higher scores reflecting greater depression symptom severity.
Measured: 1-month
Self-Reported Rumination
Self-report of rumination symptoms pre-mbNF assessed through the Ruminative Response Scale; 22-items with each item ranging from 1-4; Higher scores reflect greater rumination
Measured: Immediately Post-mbNF procedure
Self-Reported Rumination
Self-report of rumination symptoms from post-mbNF assessed through the Ruminative Response Scale; 22-items with each item ranging from 1-4; Higher scores reflect greater rumination
Measured: Immediately Post-mbNF procedure
Self-Reported Rumination
self-report of rumination symptoms 1-month post mbNF assessed through the Ruminative Response Scale; 22-items with each item ranging from 1-4; Higher scores reflect greater rumination
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start10 Apr 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Randy P. Auerbach, Ph.D., ABPP, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617495
- Sponsor's protocol ID
- AAAV1161
- Other IDs
- R61MH132072-01
- Acronym
- mbNF
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be uploaded to the NIMH NDA.
Publications
Bloom PA, Pagliaccio D, Zhang J, Bauer CCC, Kyler M, Greene KD, Treves I, Morfini F, Durham K, Cherner R, Bajwa Z, Wool E, Olafsson V, Lee RF, Bidmead F, Cardona J, Kirshenbaum JS, Ghosh S, Hinds O, Wighton P, Galfalvy H, Simpson HB, Whitfield-Gabrieli S, Auerbach RP. Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents. BMC Psychiatry. 2023 Oct 17;23(1):757. doi: 10.1186/s12888-023-05223-8.
PubMed 37848857
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Adolescent Depression Symptoms Using Network-based Real-time fMRI Neurofeedback and Mindfulness Meditation (NIMH); Mindfulness-Based Real-Time fMRI Neurofeedback for Depression (IRB)
- ClinicalTrials.gov ID
- NCT05617495
- Acronym / sponsor ID
- mbNF / AAAV1161
- Conditions
- Depression in Adolescence, Rumination
- Keywords
- Real-time fMRI Neurofeedback, Mindfulness, Rumination, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response. Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.
Detailed description
Adolescent major depressive disorder (MDD) is common and debilitating. Presently, gold-standard treatments are only effective for approximately half of patients, underscoring the need to develop novel interventions, particularly to target core underlying mechanisms and more effectively treat this recurrent disorder.
Rumination, the tendency to perseverate about depressive symptoms, contributes to MDD onset and predicts treatment non-response and relapse. At the neural level, rumination is characterized by elevated functional connectivity within the default mode network (DMN), and similarly, prior research has consistently demonstrated patterns of DMN hyper-connectivity in MDD. Interestingly, mindfulness meditation, which trains attentional focus to the present moment, reduces perseverative thinking, ruminative tendencies, and depression symptoms. Further, prior research have shown that adolescents can apply mindfulness practices to decrease perceived stress, increase sustained attention, and suppress DMN activity. Although mindfulness has profound mental health benefits, for some, mindfulness alone may not be sufficient to mitigate ruminative tendencies during a depressive episode. That is, MDD symptoms, including reduced motivation, inattention, and lack of self-efficacy, may impede a patient's progress in successfully acquiring and utilizing mindfulness strategies necessary to change perceptions about one's environment and relationships. To directly address this challenge, this project will use real-time fMRI neurofeedback to enhance the acquisition and utilization of mindfulness skills to better target DMN hyper-connectivity, rumination, and depressive symptoms.
Specifically, a novel, mindfulness-based, real-time neurofeedback (mbNF) paradigm will be used whereby people observe a visual display of their brain activity and practice mindfulness to volitionally reduce DMN activation. Adolescents (N=90; ages 13-18 years) diagnosed with MDD will complete a ~45-minute mindfulness training outside the MRI scanner. To test target engagement of reducing DMN hyper-connectivity and dosing effects, adolescents will all receive mbNF and changes in brain connectivity will be examined (primary outcome). To examine dosing effects, adolescents will be randomized to receive either a 15- or a 30-minute mbNF session (n=45/dose group). Clinician-administered instruments, self-reports, and smartphone ecological momentary assessment will be used test whether mbNF contributes to a greater reduction in clinician assessed depression symptoms as well as decreased rumination post-treatment (secondary outcomes). As a whole, mbNF is directly in line with precision medicine initiatives, and if successful, could revolutionize clinical care for depressed adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15-Minute mbNF | Active comparator | Other: Mindfulness + fMRI NeurofeedbackParticipants receiving mindfulness training and 15-minute session of mbNF |
| 30-Minute mbNF | Active comparator | Other: Mindfulness + fMRI NeurofeedbackParticipants receiving mindfulness training and 30-minute session of mbNF |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 13-18 years-old
- Written informed assent/consent and parental/guardian permission for 13-17 year-olds or informed consent for 18 year-olds
- Tanner puberty stage ≥3
- Meets current diagnostic criteria for MDD
- English fluency
Key exclusion criteria (8 listed)
- Lifetime history of primary psychotic disorders, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorders
- Substance use disorder, moderate or severe in past 6 months
- Active suicidal ideation with a specific plan
- History of seizure disorder
- Medical or neurological illness (e.g., severe head injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness + fMRI NeurofeedbackAlso: Mindfulness-based Real-time fMRI NeurofeedbackPrior to neurofeedback, participants will receive 45 minutes of mindfulness training. Participants will then receive mindfulness-based fMRI neurofeedback targeting the default mode network and frontoparietal control network. | Other | 15-Minute mbNF, 30-Minute mbNF |
Primary outcome
Within-person Default Mode Network (DMN) Connectivity
Time frame: Pre-mbNF procedure
DMN change will be assessed via fMRI from before mbNF.
Within-person Default Mode Network (DMN) Connectivity
Time frame: Post-mbNF procedure
DMN connectivity will be assessed via fMRI from post mbNF. Changes in DMN connectivity following mbNF are anticipated.
8 secondary outcomes
Self-Report Depression Symptoms
Time frame: Pre-mbNF procedure
Self-Report Depression Symptoms
Time frame: Immediately Post-mbNF procedure
Self-Report Depression Symptoms
Time frame: 1-month
Interviewer-Assessed Depression Symptoms
Time frame: Baseline
Interviewer-Assessed Depression Symptoms
Time frame: 1-month
Self-Reported Rumination
Time frame: Immediately Post-mbNF procedure
Self-Reported Rumination
Time frame: Immediately Post-mbNF procedure
Self-Reported Rumination
Time frame: 1-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 37848857Bloom PA, Pagliaccio D, Zhang J, Bauer CCC, Kyler M, Greene KD, Treves I, Morfini F, Durham K, Cherner R, Bajwa Z, Wool E, Olafsson V, Lee RF, Bidmead F, Cardona J, Kirshenbaum JS, Ghosh S, Hinds O, Wighton P, Galfalvy H, Simpson HB, Whitfield-Gabrieli S, Auerbach RP. Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents. BMC Psychiatry. 2023 Oct 17;23(1):757. doi: 10.1186/s12888-023-05223-8.
- Individual participant dataSharing planned: No. De-identified data will be uploaded to the NIMH NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simryn Molina, BA contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness + fMRI Neurofeedback in people with Depression in Adolescence and Rumination, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randy P Auerbach, PhD (646-774-5745, rpa2009@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-person Default Mode Network (DMN) Connectivity (time frame: Pre-mbNF procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05617495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.