Recruiting

Mindfulness-Based Neurofeedback

Sponsor:

Columbia University

Code:

NCT05617495

Conditions

Depression in Adolescence

Rumination

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Mindfulness + fMRI Neurofeedback

Study Details

Brief 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, 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.

Conditions

Depression in Adolescence

Rumination

Study ID

NCT05617495

Start date

Apr 10, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 15-Minute mbNF

Participants receiving mindfulness training and 15-minute session of mbNF

active comparator: 30-Minute mbNF

Participants receiving mindfulness training and 30-minute session of mbNF

Interventions

Mindfulness + 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.

Primary outcome measure

  • Within-person Default Mode Network (DMN) Connectivity [ Time Frame: Pre-mbNF procedure ]
  • Within-person Default Mode Network (DMN) Connectivity [ Time Frame: Post-mbNF procedure ]

Central Contacts and Locations

Central contacts

Randy P Auerbach, PhD

646-774-5745rpa2009@cumc.columbia.edu

Simryn Molina, BA

simryn.molina@nyspi.columbia.edu

Locations

Northeastern University

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Susan Whitfield-Gabrieli, PhD

s.whitfield-gabrieli@northeastern.edu

Principal Investigator:

Susan Whitfield-Gabrieli, PhD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Randy P Auerbach, PhD

646-774-5745rpa2009@cumc.columbia.edu

Principal Investigator:

Randy Auerbach, PhD

More Information

Sponsor

Columbia University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Real-time fMRI Neurofeedback
  • Mindfulness
  • Rumination
  • Major Depressive Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-29.