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Randomized Controlled Trial
. 2023 Oct 17;23(1):757.
doi: 10.1186/s12888-023-05223-8.

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

Paul A Bloom  1 , David Pagliaccio  2 , Jiahe Zhang  3 , Clemens C C Bauer  3   4 , Mia Kyler  2 , Keara D Greene  3 , Isaac Treves  4 , Francesca Morfini  3 , Katherine Durham  2 , Rachel Cherner  2 , Zia Bajwa  2 , Emma Wool  2 , Valur Olafsson  5 , Ray F Lee  6 , Fred Bidmead  5 , Jonathan Cardona  6 , Jaclyn S Kirshenbaum  2 , Satrajit Ghosh  7 , Oliver Hinds  8 , Paul Wighton  9 , Hanga Galfalvy  2 , H Blair Simpson  2 , Susan Whitfield-Gabrieli #  3   5 , Randy P Auerbach #  2
Affiliations
Randomized Controlled Trial

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

Paul A Bloom et al. BMC Psychiatry. .

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.

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Conflict of interest statement

During the past 3 years, Dr. Auerbach has received funding from the NIMH, Tommy Fuss Fund, and Morgan Stanley Foundation. Dr. Auerbach is an unpaid scientific advisor for Ksana Health and paid scientific advisor for Get Sonar, Inc. All other authors report no biomedical financial interests or potential conflicts of interest.

Figures

Fig. 1
Fig. 1
Protocol Overview. Screening and baseline assessment (videocall) will be followed by the in-person MRI visit approximately 1 week after baseline. Follow-up assessments will be approximately 1 month after the MRI visit. Ecological Momentary Assessment (EMA) prompts will be delivered during the week after the baseline assessment and MRI visit, as well as the week leading up to the follow-up assessment. WASI-II = Wechsler Abbreviated Scale of Intelligence-II, K-SADS = Kiddie-Schedule for Affective Disorders and Schizophrenia, CDRS-R = Children’s Depression Rating Scale-Revised, C-SSRS = Columbia-Suicide Severity Rating Scale, mbNF = mindfulness-based real-time fMRI neurofeedback, gradCPT = gradual onset continuous performance task. For the current protocol, visits refer to study interactions on separate days (Screening visit, baseline visit, MRI visit, and 1-month follow-up visit), while MRI sessions refer to continuous windows of time within visits when the participant is in the scanner (MRI Session 1, MRI Session 2). A free stock image from Vecteezy.com was used in this figure
Fig. 2
Fig. 2
MRI Visit Overview. Participants will be randomized to receive either a 15-min or 30-min dose of mbNF at MRI session 2. In the upper right hand corner, shaded rectangles indicate 3-min fMRI runs with (blue) versus without (red, with X) real-time neurofeedback. gradCPT = gradual onset continuous performance task, rsfMRI = resting-state functional magnetic resonance imaging. A free stock image from Vecteezy.com was used in this figure
Fig. 3
Fig. 3
Personalized DMN and FPN Mask Generation. Examples of personalized DMN and FPN masks are shown for a pilot scan in native space
Fig. 4
Fig. 4
Mindfulness-based Real-time fMRI Neurofeedback Schematic. Participants will be instructed to practice mental noting while undergoing fMRI (top panel). In real time, fMRI data will be analyzed using Multivariate and Univariate Real-time Functional Imaging (MURFI) for FPN relative to DMN activation (bottom left panel). The targeted state is greater FPN relative to DMN activation. The difference between FPN and DMN activation will determine the velocity of a small white ball upwards (when FPN > DMN) and downwards (when DMN > FPN) towards two larger circles displayed to the participant via PsychoPy (bottom right panel). A free stock image from Vecteezy.com was used in this figure
See this image and copyright information in PMC

References

    1. Shorey S, Ng ED, Wong CHJ. Global prevalence of depression and elevated depressive symptoms among adolescents: A systematic review and meta-analysis. Br J Clin Psychol. 2022;61(2):287–305. - PubMed
    1. Substance Abuse and Mental Health Services Administration. Mental Health Services Administration. Key substance use and mental health indicators in the United States: results from the 2021 National Survey on Drug Use and Health (HHS Publication No. PEP22–07–01–005, NSDUH Series H-57). Cent Behav Health Stat Qual Subst Abuse Ment Health Serv Adm. 2022. p. 37-40.
    1. Wilson S, Dumornay NM. Rising Rates of Adolescent Depression in the United States: Challenges and Opportunities in the 2020s. J Adolesc Health Off Publ Soc Adolesc Med. 2022;70(3):354–355. - PMC - PubMed
    1. Lu W. Adolescent Depression: National Trends, Risk Factors, and Healthcare Disparities. Am J Health Behav. 2019;43(1):181–194. - PubMed
    1. World Health Organization. World mental health report: transforming mental health for all. World Health Organization; 2022. Cited 2023 Mar 5. Available from: https://archive.hshsl.umaryland.edu/handle/10713/20295. Accessed 22 Sept 2023.

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