Mindfulness-Based fMRI Neurofeedback for Depression

NCT05617495 | Recruiting DMC

• 2 other identifiers: AAAV1161R61MH132072-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Rumination; Depression in Adolescence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Within-person Default Mode Network (DMN) Connectivity

  DMN change will be assessed via fMRI from before mbNF.

  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.

  Post-mbNF procedure

Secondary Outcomes (8)

• Self-Report Depression Symptoms

  Pre-mbNF procedure

• Self-Report Depression Symptoms

  Immediately Post-mbNF procedure

• Self-Report Depression Symptoms

  1-month

• Interviewer-Assessed Depression Symptoms

  Baseline

• Interviewer-Assessed Depression Symptoms

  1-month

Other Outcomes (7)

• Ecological Momentary Assessment of Depression Symptoms

  Immediately Post-mbNF procedure

• Ecological Momentary Assessment of Depression Symptoms

  1-month

• Ecological Momentary Assessment of Rumination

  Immediately Post-mbNF procedure

Study Arms (2)

15-Minute mbNF

ACTIVE COMPARATOR

Participants receiving mindfulness training and 15-minute session of mbNF

Other: Mindfulness + fMRI Neurofeedback

30-Minute mbNF

ACTIVE COMPARATOR

Participants receiving mindfulness training and 30-minute session of mbNF

Other: Mindfulness + fMRI Neurofeedback

Interventions

Mindfulness + fMRI Neurofeedback OTHER

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.

Also known as: Mindfulness-based Real-time fMRI Neurofeedback

15-Minute mbNF; 30-Minute mbNF

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37848857 DERIVED

MeSH Terms

Conditions

Rumination Syndrome; Depressive Disorder, Major

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Randy P Auerbach, PhD

CONTACT

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

Simryn Molina, BA

CONTACT

simryn.molina@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 15, 2022
• Study Start: April 10, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)