mbNF: Mindfulness-Based fMRI Neurofeedback for Depression

Sponsor

Columbia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05617495

Collaborator

Northeastern University (Other)

Enrollment

Arms

25.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression in Adolescence Rumination	Other: fMRI Neurofeedback	N/A

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. 90 adolescents (ages 13-18) diagnosed with MDD will complete a 45-minute mindfulness training outside the scanner. To test target engagement of reducing DMN hyper-connectivity and optimal dosing, adolescents will then be randomized to receive either a 15- or a 30-minute mbNF session (n=45/dose group). Clinician-administered instruments, self-reports, and ecological momentary assessment will be used test whether mbNF contributes to a greater reduction in clinician assessed depression symptoms (primary outcome) as well as decreased rumination (secondary outcome) across the post-treatment and 1-month post-treatment. As a whole, mbNF is directly in line with precision medicine initiatives, and if successful, could revolutionize clinical care for depressed adolescents.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Mindfulness-Based Real-Time fMRI Neurofeedback for Adolescent Depression

Anticipated Study Start Date :

Feb 2, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 15-Minute mbNF Participants receiving 15-minute session of mbNF	Other: fMRI Neurofeedback Participants will receive mindfulness-based fMRI neurofeedback targeting the default mode network and central executive network. Other Names: Mindfulness-based Real-time fMRI Neurofeedback
Active Comparator: 30-Minute mbNF Participants receiving 30-minute session of mbNF	Other: fMRI Neurofeedback Participants will receive mindfulness-based fMRI neurofeedback targeting the default mode network and central executive network. Other Names: Mindfulness-based Real-time fMRI Neurofeedback

Arm

Intervention/Treatment

Active Comparator: 15-Minute mbNF

Participants receiving 15-minute session of mbNF

Other: fMRI Neurofeedback

Participants will receive mindfulness-based fMRI neurofeedback targeting the default mode network and central executive network.

Other Names:

Mindfulness-based Real-time fMRI Neurofeedback

Active Comparator: 30-Minute mbNF

Participants receiving 30-minute session of mbNF

Other: fMRI Neurofeedback

Participants will receive mindfulness-based fMRI neurofeedback targeting the default mode network and central executive network.

Other Names:

Mindfulness-based Real-time fMRI Neurofeedback

Outcome Measures

Primary Outcome Measures

Within-person Default Mode Network (DMN) Connectivity [Immediately Post-mbNF procedure]
DMN change will be assessed via fMRI from pre and post mbNF. We anticipate changes in DMN connectivity following mbNF.

Secondary Outcome Measures

Self-Report Depression Symptoms [Immediately Post-mbNF procedure]
Change in self-report of depression symptoms from baseline to post-mbNF assessed through the Mood and Feelings QuestionnaireSelf-report of depression symptoms through the Mood and Feelings Questionnaire; 33-items with each item ranging from 0-2; Higher scores reflect greater depression symptom severity.
Self-Report Depression Symptoms [1-month]
Change in self-report of depression symptoms from baseline to 1-month post-mbNF assessed through the Mood and Feelings Questionnaire; 33-items with each item ranging from 0-2; Higher scores reflect greater depression symptom severity.
Interviewer-Assessed Depression Symptoms [1-month]
Change in depressive symptoms from baseline to 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.
Self-Reported Rumination [Immediately Post-mbNF procedure]
Change in self-report of rumination symptoms from baseline to post-mbNF assessed assessed through the Ruminative Response Scale; 22-items with each item ranging from 1-4; Higher scores reflect greater rumination.
Self-Reported Rumination [1-month]
Change in self-report of rumination symptoms from baseline to 1-month post-mbNF assessed through the Ruminative Response Scale; 22-items with each item ranging from 1-4; Higher scores reflect greater rumination.

Other Outcome Measures

Ecological Momentary Assessment of Depression Symptoms [Immediately Post-mbNF procedure]
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.
Ecological Momentary Assessment of Depression Symptoms [1-month]
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.
Ecological Momentary Assessment of Rumination [Immediately Post-mbNF procedure]
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.
Ecological Momentary Assessment of Rumination [1-month]
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.
Ecological Momentary Assessment of Mindfulness [Immediately Post-mbNF procedure]
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.
Ecological Momentary Assessment of Mindfulness [1-month]
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.
Default Mode Network (DMN) and Frontoparietal Control Network (FPCN) Anticorrelation [Immediately Post-mbNF procedure]
Anticorrelation between DMN and FPCN will be assessed via fMRI from pre and post mbNF. We anticipate changes in DMN-FPCN anticorrelation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages 13-18 years-old
Written informed assent/consent; parental/guardian permission for 13-17 year-olds or consent for 18 year-olds
Tanner puberty stage ≥3
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., head injury, loss of consciousness >5 minutes)
MRI contraindications
Current psychotropic medication use other than antidepressant medication
Intelligence quotient (IQ) <80.