Clinical trial NCT05617495: Mindfulness-Based fMRI Neurofeedback for Depression
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression in Adolescence
Rumination
Keywords: Real-time fMRI Neurofeedback
Mindfulness
Rumination
Major Depressive Disorder
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Within-person Default Mode Network (DMN) Connectivity
timeFrame: Pre-mbNF procedure
measure: Within-person Default Mode Network (DMN) Connectivity
timeFrame: Post-mbNF procedure
Secondary outcomes:
measure: Self-Report Depression Symptoms
timeFrame: Pre-mbNF procedure
measure: Self-Report Depression Symptoms
timeFrame: Immediately Post-mbNF procedure
measure: Self-Report Depression Symptoms
timeFrame: 1-month
measure: Interviewer-Assessed Depression Symptoms
timeFrame: Baseline
measure: Interviewer-Assessed Depression Symptoms
timeFrame: 1-month
measure: Self-Reported Rumination
timeFrame: Immediately Post-mbNF procedure
measure: Self-Reported Rumination
timeFrame: Immediately Post-mbNF procedure
measure: Self-Reported Rumination
timeFrame: 1-month
Other outcomes:
measure: Ecological Momentary Assessment of Depression Symptoms
timeFrame: Immediately Post-mbNF procedure
measure: Ecological Momentary Assessment of Depression Symptoms
timeFrame: 1-month
measure: Ecological Momentary Assessment of Rumination
timeFrame: Immediately Post-mbNF procedure
measure: Ecological Momentary Assessment of Rumination
timeFrame: 1-month
measure: Ecological Momentary Assessment of Mindfulness
timeFrame: Immediately Post-mbNF procedure
measure: Ecological Momentary Assessment of Mindfulness
timeFrame: 1-month
measure: Default Mode Network (DMN) and Frontoparietal Control Network (FPCN) Connectivity
timeFrame: Immediately Post-mbNF procedure
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
References: