Key result
New RCT protocol tests if mindfulness-based fMRI neurofeedback reduces DMN connectivity in depressed adolescents.
Why the study?
Treatments for adolescent Major Depressive Disorder are effective in only about half of patients, necessitating novel non-invasive interventions to reduce depressive symptoms and rumination.
Does 30 minutes of mindfulness-based real-time fMRI neurofeedback improve within-DMN functional connectivity compared to 15 minutes in adolescents with MDD?
RCT (n=90)
Open-label
Parallel group
Yes
Does 30 minutes of mindfulness-based real-time fMRI neurofeedback improve within-DMN functional connectivity compared to 15 minutes in adolescents with MDD?
This study protocol outlines a trial to determine the optimal dosing of mindfulness-based real-time fMRI neurofeedback for reducing default mode network functional connectivity and depressive symptoms in adolescents with MDD.
This RCT will test optimal dosing of real-time fMRI neurofeedback for DMN connectivity in adolescent MDD; extends neuromodulation evidence to guide future trials.
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 minutes 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-minute 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).
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Bloom et al. (2023) conducted an RCT in Major Depressive Disorder (MDD) (n=90). Mindfulness-based real-time fMRI neurofeedback (mbNF) vs. 15 minutes of mbNF was evaluated on Reduction in within-DMN functional connectivity. This study protocol outlines a randomized controlled trial to determine whether 15 or 30 minutes of mindfulness-based real-time fMRI neurofeedback reduces DMN functional connectivity in depressed adolescents.
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