Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents

Paul A Bloom; David Pagliaccio; Jiahe Zhang; Clemens C C Bauer; Mia Kyler; Keara D Greene; Isaac Treves; Francesca Morfini; Katherine Durham; Rachel Cherner; Zia Bajwa; Emma Wool; Valur Olafsson; Ray F Lee; Fred Bidmead; Jonathan Cardona; Jaclyn S Kirshenbaum; Satrajit Ghosh; Oliver Hinds; Paul Wighton; Hanga Galfalvy; H Blair Simpson; Susan Whitfield-Gabrieli; Randy P Auerbach

doi:10.1186/s12888-023-05223-8

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.

Authors

Paul A Bloom¹, David Pagliaccio², Jiahe Zhang³, Clemens C C Bauer^{3

4}, Mia Kyler², Keara D Greene³, Isaac Treves⁴, Francesca Morfini³, Katherine Durham², Rachel Cherner², Zia Bajwa², Emma Wool², Valur Olafsson⁵, Ray F Lee⁶, Fred Bidmead⁵, Jonathan Cardona⁶, Jaclyn S Kirshenbaum², Satrajit Ghosh⁷, Oliver Hinds⁸, Paul Wighton⁹, Hanga Galfalvy², H Blair Simpson², Susan Whitfield-Gabrieli^#^{3

5}, Randy P Auerbach^#²

Affiliations

¹ Department of Psychiatry, Columbia University, New York, NY, USA. paul.bloom@nyspi.columbia.edu.
² Department of Psychiatry, Columbia University, New York, NY, USA.
³ Department of Psychology, Northeastern University, Boston, MA, USA.
⁴ Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, MA, USA.
⁵ Northeastern University Biomedical Imaging Center, Boston, MA, USA.
⁶ Zuckerman Mind Brain and Behavior Institute, Columbia University, New York, NY, USA.
⁷ Harvard Medical School, Boston, MA, USA.
⁸ Orchard Scientific, Yucca Valley, CA, USA.
⁹ Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, MA, USA.

^# Contributed equally.

Abstract

Background: Adolescence is characterized by a heightened vulnerability for Major Depressive Disorder (MDD) onset, and currently, treatments are only effective for roughly half of adolescents with MDD. Accordingly, novel interventions are urgently needed. This study aims to establish mindfulness-based real-time fMRI neurofeedback (mbNF) as a non-invasive approach to downregulate the default mode network (DMN) in order to decrease ruminatory processes and depressive symptoms.

Methods: Adolescents (N = 90) with a current diagnosis of MDD ages 13-18-years-old will be randomized in a parallel group, two-arm, superiority trial to receive either 15 or 30 min of mbNF with a 1:1 allocation ratio. Real-time neurofeedback based on activation of the frontoparietal network (FPN) relative to the DMN will be displayed to participants via the movement of a ball on a computer screen while participants practice mindfulness in the scanner. We hypothesize that within-DMN (medial prefrontal cortex [mPFC] with posterior cingulate cortex [PCC]) functional connectivity will be reduced following mbNF (Aim 1: Target Engagement). Additionally, we hypothesize that participants in the 30-min mbNF condition will show greater reductions in within-DMN functional connectivity (Aim 2: Dosing Impact on Target Engagement). Aim 1 will analyze data from all participants as a single-group, and Aim 2 will leverage the randomized assignment to analyze data as a parallel-group trial. Secondary analyses will probe changes in depressive symptoms and rumination.

Discussion: Results of this study will determine whether mbNF reduces functional connectivity within the DMN among adolescents with MDD, and critically, will identify the optimal dosing with respect to DMN modulation as well as reduction in depressive symptoms and rumination.

Trial registration: This study has been registered with clinicaltrials.gov, most recently updated on July 6, 2023 (trial identifier: NCT05617495).

Keywords: Adolescence; DMN; FPN; MDD; Mindfulness; Real-time fMRI neurofeedback.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Brain / diagnostic imaging
Brain Mapping / methods
Depressive Disorder, Major* / diagnostic imaging
Depressive Disorder, Major* / therapy
Gyrus Cinguli / diagnostic imaging
Humans
Magnetic Resonance Imaging / methods
Mindfulness*
Neurofeedback* / methods

Associated data

ClinicalTrials.gov/NCT05617495

Grants and funding

R61 MH132072/MH/NIMH NIH HHS/United States