Mindfulness-Based fMRI Neurofeedback for Depression

ConditionsDepression in Adolescence Rumination

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-18

SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Mindfulness + fMRI Neurofeedback
Other intervention
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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: 15-Minute mbNFActive comparator 1 intervention

Group B: 30-Minute mbNFActive comparator 1 intervention

Trial outcomes

Primary outcomes

Within-person Default Mode Network (DMN) Connectivity

DMN change will be assessed via fMRI from before mbNF.

Time frame

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.

Time frame

Post-mbNF procedure

Secondary outcomes

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

Time frame

Pre-mbNF procedure

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

Time frame

Immediately Post-mbNF procedure

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

Time frame

1-month

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.

Time frame

Baseline

Other outcomes

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.

Time frame

Immediately Post-mbNF procedure

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.

Time frame

1-month

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.

Time frame

Immediately Post-mbNF procedure

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.

Time frame

1-month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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