Mindfulness-Based fMRI Neurofeedback for Depression

NCT ID: NCT05617495

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2026-06-30

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.

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, our research and others 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

15-Minute mbNF

Participants receiving mindfulness training and 15-minute session of mbNF

Group Type: ACTIVE_COMPARATOR

Mindfulness + fMRI Neurofeedback

Intervention Type: 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.

30-Minute mbNF

Participants receiving mindfulness training and 30-minute session of mbNF

Group Type: ACTIVE_COMPARATOR

Mindfulness + fMRI Neurofeedback

Intervention Type: 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.

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.

Intervention Type: OTHER

Other Intervention Names

Mindfulness-based Real-time fMRI Neurofeedback

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Randy P. Auerbach, Ph.D., ABPP

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northeastern University

Boston, Massachusetts, United States

Site Status: RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Randy P Auerbach, PhD

Role: CONTACT

rpa2009@cumc.columbia.edu

646-774-5745

Emma Wool, BA

Role: CONTACT

emma.wool@nyspi.columbia.edu

Facility Contacts

Susan Whitfield-Gabrieli, PhD

Role: primary

s.whitfield-gabrieli@northeastern.edu

Randy P Auerbach, PhD

Role: primary

rpa2009@cumc.columbia.edu

646-774-5745

Randy P Auerbach

Role: backup

References

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.

Reference Type: DERIVED

PMID: 37848857 (View on PubMed)

Other Identifiers

R61MH132072-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAV1161

Identifier Type: -

Identifier Source: org_study_id