Mindfulness-based Real-time fMRI Neurofeedback: A Randomized Controlled Trial to Optimize Dosing for Depressed Adolescents (Study Protocol)
Paul Alexander Bloom, David Pagliaccio, Jiahe Zhang, Clemens C C Bauer, Mia Kyler, Keara D Greene, Isaac N Treves, Francesca Morfini, Katherine Durham, Rachel Cherner, Zia Bajwa, Emma Wool, Valur T. Olafsson, Ray F. Lee, Jonathan Cardona, Jaclyn Schwartz Kirshenbaum, Satrajit Ghosh, Oliver Hinds, Paul Wighton, Hanga C Galfalvy, Blair H. Simpson, Susan Whitfield-Gabrieli, Randy Patrick Auerbach
September 23, 2023 preprint DOI: 10.31234/osf.io/v3fqx (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol |
|---|---|
| Sample size | 90 |
| Population | Adolescents aged 13-18 with a current diagnosis of major depressive disorder |
| Intervention | Mindfulness-based real-time fMRI neurofeedback (mbNF) |
| Dose | 15 or 30 minutes |
| Topics | Meditation |
| Registration | NCT05617495 |
| Key findings | The protocol proposes that mindfulness-based real-time fMRI neurofeedback will reduce within-default mode network functional connectivity in adolescents with major depressive disorder, and that a 30-minute dose will produce greater reductions than a 15-minute dose. Secondary analyses will assess changes in depressive symptoms and rumination. |
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 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).
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 15
- A default mode of brain function Proceedings of the National Academy of Sciences January 16, 2001
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation Perspectives on Psychological Science October 10, 2017
- Functional connectivity of default mode network components: Correlation, anticorrelation, and causality Human Brain Mapping January 24, 2008
- States of Mind: Characterizing the Neural Bases of Focus and Mind-wandering through Dynamic Functional Connectivity Journal of Cognitive Neuroscience October 25, 2016
and 10 more in the library