Mindfulness-Based fMRI Neurofeedback for Depression

Rumination Clinical Trial

— mbNF  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617495
• Other study ID #: CU AAAV1161
• Secondary ID: R61MH132072-01
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Randy P Auerbach, PhD
• Phone: 646-774-5745
• Email: rpa2009[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression in Adolescence
• Depressive Disorder
• Rumination

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts
United States	CUIMC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ecological Momentary Assessment of Depression Symptoms	Change in self-report of depressive symptoms from baseline to post-mbNF assessed through the Patient Health Questionnaire (PHQ)-2 delivered via ecological momentary assessment over a 7-day period; 2-items with each item ranging from 0-100; Higher scores reflect greater depression severity.	Immediately Post-mbNF procedure
Other	Ecological Momentary Assessment of Depression Symptoms	Change in self-report of depressive symptoms from baseline to 1-month post-mbNF assessed through the Patient Health Questionnaire (PHQ)-2 delivered via ecological momentary assessment over a 7-day period; 2-items with each item ranging from 0-100; Higher scores reflect greater depression severity.	1-month
Other	Ecological Momentary Assessment of Rumination	Change in self-report of rumination (5-items) from baseline to post-mbNF assessed via ecological momentary assessment over a 7-day period; 5-items with each item ranging from 0-100; Higher scores reflect greater rumination.	Immediately Post-mbNF procedure
Other	Ecological Momentary Assessment of Rumination	Change in self-report of rumination (5-items) from baseline to 1-month post-mbNF assessed via ecological momentary assessment over a 7-day period; 5-items with each item ranging from 0-100; Higher scores reflect greater rumination.	1-month
Other	Ecological Momentary Assessment of Mindfulness	Change in self-report of mindfulness (3-items) from baseline to post-mbNF assessed via ecological momentary assessment over a 7-day period; 3-items with each item ranging from 0-100; Higher scores reflect greater mindfulness.	Immediately Post-mbNF procedure
Other	Ecological Momentary Assessment of Mindfulness	Change in self-report of mindfulness (3-items) from baseline to 1-month post-mbNF assessed via ecological momentary assessment over a 7-day period; 3-items with each item ranging from 0-100; Higher scores reflect greater mindfulness.	1-month
Other	Default Mode Network (DMN) and Frontoparietal Control Network (FPCN) Connectivity	Anticorrelation between DMN and FPCN will be assessed via fMRI from pre and post mbNF. Changes in DMN-FPCN anticorrelation are anticipated.	Immediately Post-mbNF procedure
Primary	Within-person Default Mode Network (DMN) Connectivity	DMN change will be assessed via fMRI from before mbNF.	Pre-mbNF procedure
Primary	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	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	Pre-mbNF procedure
Secondary	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	Immediately Post-mbNF procedure
Secondary	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	1-month
Secondary	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.	Baseline
Secondary	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.	1-month
Secondary	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	Immediately Post-mbNF procedure
Secondary	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	Immediately Post-mbNF procedure
Secondary	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	1-month