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
BMC psychiatry October 17, 2023 DOI: 10.1186/s12888-023-05223-8
Summary
Mindfulness-based real-time fMRI neurofeedback (mbNF) shows promise in treating Major Depressive Disorder (MDD) among adolescents, with a sample of 90 participants aged 13-18. This innovative approach aims to reduce ruminatory processes by downregulating the default mode network (DMN). Participants will be randomly assigned to receive either 15 or 30 minutes of mbNF, targeting functional connectivity between the medial prefrontal cortex and posterior cingulate cortex. The study seeks to identify optimal dosing for effective symptom reduction and improved mental health outcomes.
Abstract
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. 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. 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. This study has been registered with clinicaltrials.gov, most recently updated on July 6, 2023 (trial identifier: NCT05617495).