Development of the Neuroimaging Biomarker-based Prediction Model of Anxiety-related Disorders: Effect of Mindfulness-based Cognitive Therapy Using Neuroscience on the Brain

NCT05911412 | Unknown

• 1 other identifier: 2022-10-041-002
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study designed a randomized clinical trial is to determine the efficacy of an 8-week mindfulness-based cognitive therapy using neuroscience (NMBCT) to reduce anxiety or depressive symptoms among adult participants with anxiety and depression. The primary object is to assess the effectiveness of NMBCT to change in the structural or functional brain. A secondary objective is to reduce clinical symptom severity.

Conditions

Anxiety Depression

Keywords

mindfulness-based cognitive therapy; mri; neuroscience

Outcome Measures

Primary Outcomes (9)

• Change in GMV measured with sMRI

  Change in gray matter volume (GMV) in mm3 measured with structural MRI (sMRI)

  baseline, 8 weeks after treatment

• Change in CT measured with sMRI

  Change in cortical thickness (CT) in mm measured with structural MRI (sMRI)

  baseline, 8 weeks after treatment

• Change in SA measured with sMRI

  Change in surface area (SA) in mm2 measured with structural MRI (sMRI)

  baseline, 8 weeks after treatment

• Change LGI measured with sMRI

  Change in local gyrification index (LGI), ranged from 0 to 1, measured with structural MRI (sMRI)

  baseline, 8 weeks after treatment

• Change in FA measured with DTI

  Change in fractional anisotropy (FA), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.

  baseline, 8 weeks after treatment

• Change in MD measured with DTI

  Change in mean diffusivity (MD), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.

  baseline, 8 weeks after treatment

• Change in AD measured with DTI

  Change in axial diffusivity (AD), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.

  baseline, 8 weeks after treatment

• Change in RD measured with DTI

  Change in radial diffusivity (AD), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.

  baseline, 8 weeks after treatment

• Change in FC measured with fMRI

  Change in functional connectivity (FC) in resting-state functional MRI (fMRI).

  baseline, 8 weeks after treatment

Secondary Outcomes (11)

• The changes in the Korean version of Panic Disorder Severity Scale (PDSS).

  baseline, 8 week after treatment

• The change in the Korean version of Albany Panic and Phobia Questionnaire (APPQ)

  baseline, 8 week after treatment

• The change in the Korean version of the Beck Depression Inventory (BDI)-II

  baseline, 8 week after treatment

• The change in the Korean version of the Beck Anxiety Inventory (BAI)

  baseline, 8 week after treatment

• The change in the Korean version of the Penn State Worry Questionnaire (PSWQ)

  baseline, 8 week after treatment

Study Arms (2)

NMBCT intervention

EXPERIMENTAL

Participants in this arm enter the 8-week NMBCT course immediately after the baseline visit.

Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)

Waitlist

EXPERIMENTAL

Participants in the waitlist control arm will wait for 8 weeks after the baseline visit, and then will be offered an identical 8-week NMBCT course.

Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)

Interventions

Mindfulness-based cognitive therapy using neuroscience (NMBCT) BEHAVIORAL

Mindfulness-based cognitive therapy using neuroscience (NMBCT) is a standardized 8-week course taught by trained instructors. The NMBCT is a group therapy that takes place once a week for about 90 minutes per session. The program consists of mental education for each session, 2-3 mindfulness meditation practice, mindfulness practice in daily life, and about 30 minutes of daily home mindfulness meditation task. While participating in the program, the subjects will receive psychoeducation and various mindfulness meditation techniques (eating meditation, breathing meditation, sedentary meditation, viewing meditation, and listening meditation, etc.).

NMBCT intervention; Waitlist

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 19 years of age
• a Beck Depression Inventory score of more than 5 but less than 20 points
• a Beck Anxiety Inventory score of more than 5 but less than 25 points
• A person who has been sufficiently explained and understood the contents of clinical trials, and maintains the ability to make a free-will decision
• Those with normal or normal corrected vision
• Those without claustrophobic symptoms
• Right-handed person
• Those who do not have a family history of psychiatric disease in the first family (parents, children, siblings)

You may not qualify if:

• Currently taking psychoactive drugs
• Those with a history of neurological disease, head trauma with loss of consciousness, or mental retardation (IQ \<70)
• A person who currently requires hospitalization due to a serious physical illness or who has not passed 6 months since discharge
• Pregnant and lactating women
• A person who is judged to be at risk of serious suicide or violent behavior in a mental status examination
• A person who is judged to have severe symptoms or significant decline in reality testing and judgment through a mental status examination by a psychiatrist
• Foreigners
• Those who are illiterate in Korean
• Those who have previously received mindfulness-based cognitive therapy
• If the researcher judges that the researcher is unsuitable for participation in clinical trials due to other reasons

Sponsors & Collaborators

• CHA University: lead
• National Research Foundation of Korea: collaborator

Related Publications (23)

• Guendelman S, Bayer M, Prehn K, Dziobek I. Towards a mechanistic understanding of mindfulness-based stress reduction (MBSR) using an RCT neuroimaging approach: Effects on regulating own stress in social and non-social situations. Neuroimage. 2022 Jul 1;254:119059. doi: 10.1016/j.neuroimage.2022.119059. Epub 2022 Mar 5.

  PMID: 35259523 BACKGROUND

• Yun JY, Boedhoe PSW, Vriend C, Jahanshad N, Abe Y, Ameis SH, Anticevic A, Arnold PD, Batistuzzo MC, Benedetti F, Beucke JC, Bollettini I, Bose A, Brem S, Calvo A, Cheng Y, Cho KIK, Ciullo V, Dallaspezia S, Denys D, Feusner JD, Fouche JP, Gimenez M, Gruner P, Hibar DP, Hoexter MQ, Hu H, Huyser C, Ikari K, Kathmann N, Kaufmann C, Koch K, Lazaro L, Lochner C, Marques P, Marsh R, Martinez-Zalacain I, Mataix-Cols D, Menchon JM, Minuzzi L, Morgado P, Moreira P, Nakamae T, Nakao T, Narayanaswamy JC, Nurmi EL, O'Neill J, Piacentini J, Piras F, Piras F, Reddy YCJ, Sato JR, Simpson HB, Soreni N, Soriano-Mas C, Spalletta G, Stevens MC, Szeszko PR, Tolin DF, Venkatasubramanian G, Walitza S, Wang Z, van Wingen GA, Xu J, Xu X, Zhao Q; ENIGMA-OCD working group; Thompson PM, Stein DJ, van den Heuvel OA, Kwon JS. Brain structural covariance networks in obsessive-compulsive disorder: a graph analysis from the ENIGMA Consortium. Brain. 2020 Feb 1;143(2):684-700. doi: 10.1093/brain/awaa001.

  PMID: 32040561 BACKGROUND

• Yook K, Lee SH, Ryu M, Kim KH, Choi TK, Suh SY, Kim YW, Kim B, Kim MY, Kim MJ. Usefulness of mindfulness-based cognitive therapy for treating insomnia in patients with anxiety disorders: a pilot study. J Nerv Ment Dis. 2008 Jun;196(6):501-3. doi: 10.1097/NMD.0b013e31817762ac.

  PMID: 18552629 BACKGROUND

• Williams LM. Precision psychiatry: a neural circuit taxonomy for depression and anxiety. Lancet Psychiatry. 2016 May;3(5):472-80. doi: 10.1016/S2215-0366(15)00579-9. Epub 2016 Apr 14.

  PMID: 27150382 BACKGROUND

• Varghese B, Chen F, Hwang D, Palmer SL, De Castro Abreu AL, Ukimura O, Aron M, Aron M, Gill I, Duddalwar V, Pandey G. Objective risk stratification of prostate cancer using machine learning and radiomics applied to multiparametric magnetic resonance images. Sci Rep. 2019 Feb 7;9(1):1570. doi: 10.1038/s41598-018-38381-x.

  PMID: 30733585 BACKGROUND

• Tang YY, Holzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015 Apr;16(4):213-25. doi: 10.1038/nrn3916. Epub 2015 Mar 18.

  PMID: 25783612 BACKGROUND

• Stein JL, Medland SE, Vasquez AA, Hibar DP, Senstad RE, Winkler AM, Toro R, Appel K, Bartecek R, Bergmann O, Bernard M, Brown AA, Cannon DM, Chakravarty MM, Christoforou A, Domin M, Grimm O, Hollinshead M, Holmes AJ, Homuth G, Hottenga JJ, Langan C, Lopez LM, Hansell NK, Hwang KS, Kim S, Laje G, Lee PH, Liu X, Loth E, Lourdusamy A, Mattingsdal M, Mohnke S, Maniega SM, Nho K, Nugent AC, O'Brien C, Papmeyer M, Putz B, Ramasamy A, Rasmussen J, Rijpkema M, Risacher SL, Roddey JC, Rose EJ, Ryten M, Shen L, Sprooten E, Strengman E, Teumer A, Trabzuni D, Turner J, van Eijk K, van Erp TG, van Tol MJ, Wittfeld K, Wolf C, Woudstra S, Aleman A, Alhusaini S, Almasy L, Binder EB, Brohawn DG, Cantor RM, Carless MA, Corvin A, Czisch M, Curran JE, Davies G, de Almeida MA, Delanty N, Depondt C, Duggirala R, Dyer TD, Erk S, Fagerness J, Fox PT, Freimer NB, Gill M, Goring HH, Hagler DJ, Hoehn D, Holsboer F, Hoogman M, Hosten N, Jahanshad N, Johnson MP, Kasperaviciute D, Kent JW Jr, Kochunov P, Lancaster JL, Lawrie SM, Liewald DC, Mandl R, Matarin M, Mattheisen M, Meisenzahl E, Melle I, Moses EK, Muhleisen TW, Nauck M, Nothen MM, Olvera RL, Pandolfo M, Pike GB, Puls R, Reinvang I, Renteria ME, Rietschel M, Roffman JL, Royle NA, Rujescu D, Savitz J, Schnack HG, Schnell K, Seiferth N, Smith C, Steen VM, Valdes Hernandez MC, Van den Heuvel M, van der Wee NJ, Van Haren NE, Veltman JA, Volzke H, Walker R, Westlye LT, Whelan CD, Agartz I, Boomsma DI, Cavalleri GL, Dale AM, Djurovic S, Drevets WC, Hagoort P, Hall J, Heinz A, Jack CR Jr, Foroud TM, Le Hellard S, Macciardi F, Montgomery GW, Poline JB, Porteous DJ, Sisodiya SM, Starr JM, Sussmann J, Toga AW, Veltman DJ, Walter H, Weiner MW; Alzheimer's Disease Neuroimaging Initiative; EPIGEN Consortium; IMAGEN Consortium; Saguenay Youth Study Group; Bis JC, Ikram MA, Smith AV, Gudnason V, Tzourio C, Vernooij MW, Launer LJ, DeCarli C, Seshadri S; Cohorts for Heart and Aging Research in Genomic Epidemiology Consortium; Andreassen OA, Apostolova LG, Bastin ME, Blangero J, Brunner HG, Buckner RL, Cichon S, Coppola G, de Zubicaray GI, Deary IJ, Donohoe G, de Geus EJ, Espeseth T, Fernandez G, Glahn DC, Grabe HJ, Hardy J, Hulshoff Pol HE, Jenkinson M, Kahn RS, McDonald C, McIntosh AM, McMahon FJ, McMahon KL, Meyer-Lindenberg A, Morris DW, Muller-Myhsok B, Nichols TE, Ophoff RA, Paus T, Pausova Z, Penninx BW, Potkin SG, Samann PG, Saykin AJ, Schumann G, Smoller JW, Wardlaw JM, Weale ME, Martin NG, Franke B, Wright MJ, Thompson PM; Enhancing Neuro Imaging Genetics through Meta-Analysis Consortium. Identification of common variants associated with human hippocampal and intracranial volumes. Nat Genet. 2012 Apr 15;44(5):552-61. doi: 10.1038/ng.2250.

  PMID: 22504417 BACKGROUND

• Sun H, Chen Y, Huang Q, Lui S, Huang X, Shi Y, Xu X, Sweeney JA, Gong Q. Psychoradiologic Utility of MR Imaging for Diagnosis of Attention Deficit Hyperactivity Disorder: A Radiomics Analysis. Radiology. 2018 May;287(2):620-630. doi: 10.1148/radiol.2017170226. Epub 2017 Nov 22.

  PMID: 29165048 BACKGROUND

• Shear MK, Bjelland I, Beesdo K, Gloster AT, Wittchen HU. Supplementary dimensional assessment in anxiety disorders. Int J Methods Psychiatr Res. 2007;16 Suppl 1(Suppl 1):S52-64. doi: 10.1002/mpr.215.

  PMID: 17623395 BACKGROUND

• Roy-Byrne PP, Craske MG, Stein MB. Panic disorder. Lancet. 2006 Sep 16;368(9540):1023-32. doi: 10.1016/S0140-6736(06)69418-X.

  PMID: 16980119 BACKGROUND

• Park YW, Choi D, Lee J, Ahn SS, Lee SK, Lee SH, Bang M. Differentiating patients with schizophrenia from healthy controls by hippocampal subfields using radiomics. Schizophr Res. 2020 Sep;223:337-344. doi: 10.1016/j.schres.2020.09.009. Epub 2020 Sep 26.

  PMID: 32988740 BACKGROUND

• Park JE, Kim HS. Radiomics as a Quantitative Imaging Biomarker: Practical Considerations and the Current Standpoint in Neuro-oncologic Studies. Nucl Med Mol Imaging. 2018 Apr;52(2):99-108. doi: 10.1007/s13139-017-0512-7. Epub 2018 Feb 1.

  PMID: 29662558 BACKGROUND

• Liang S, Ma A, Yang S, Wang Y, Ma Q. A Review of Matched-pairs Feature Selection Methods for Gene Expression Data Analysis. Comput Struct Biotechnol J. 2018 Feb 25;16:88-97. doi: 10.1016/j.csbj.2018.02.005. eCollection 2018.

  PMID: 30275937 BACKGROUND

• Klauke B, Deckert J, Reif A, Pauli P, Domschke K. Life events in panic disorder-an update on "candidate stressors". Depress Anxiety. 2010 Aug;27(8):716-30. doi: 10.1002/da.20667.

  PMID: 20112245 BACKGROUND

• Kim YW, Lee SH, Choi TK, Suh SY, Kim B, Kim CM, Cho SJ, Kim MJ, Yook K, Ryu M, Song SK, Yook KH. Effectiveness of mindfulness-based cognitive therapy as an adjuvant to pharmacotherapy in patients with panic disorder or generalized anxiety disorder. Depress Anxiety. 2009;26(7):601-6. doi: 10.1002/da.20552.

  PMID: 19242985 BACKGROUND

• Kim MK, Kim B, Kiu Choi T, Lee SH. White matter correlates of anxiety sensitivity in panic disorder. J Affect Disord. 2017 Jan 1;207:148-156. doi: 10.1016/j.jad.2016.08.043. Epub 2016 Oct 3.

  PMID: 27721189 BACKGROUND

• Insel TR, Cuthbert BN. Medicine. Brain disorders? Precisely. Science. 2015 May 1;348(6234):499-500. doi: 10.1126/science.aab2358. No abstract available.

  PMID: 25931539 BACKGROUND

• Harrison BJ, Fullana MA, Soriano-Mas C, Via E, Pujol J, Martinez-Zalacain I, Tinoco-Gonzalez D, Davey CG, Lopez-Sola M, Perez Sola V, Menchon JM, Cardoner N. A neural mediator of human anxiety sensitivity. Hum Brain Mapp. 2015 Oct;36(10):3950-8. doi: 10.1002/hbm.22889. Epub 2015 Jul 6.

  PMID: 26147233 BACKGROUND

• Hamilton SP, Slager SL, De Leon AB, Heiman GA, Klein DF, Hodge SE, Weissman MM, Fyer AJ, Knowles JA. Evidence for genetic linkage between a polymorphism in the adenosine 2A receptor and panic disorder. Neuropsychopharmacology. 2004 Mar;29(3):558-65. doi: 10.1038/sj.npp.1300311.

  PMID: 14666117 BACKGROUND

• Fraguas D, Diaz-Caneja CM, State MW, O'Donovan MC, Gur RE, Arango C. Mental disorders of known aetiology and precision medicine in psychiatry: a promising but neglected alliance. Psychol Med. 2017 Jan;47(2):193-197. doi: 10.1017/S0033291716001355. Epub 2016 Jun 23.

  PMID: 27334937 BACKGROUND

• Dow MG, Kenardy JA, Johnston DW, Newman MG, Taylor CB, Thomson A. Prognostic indices with brief and standard CBT for panic disorder: I. Predictors of outcome. Psychol Med. 2007 Oct;37(10):1493-502. doi: 10.1017/S0033291707000670. Epub 2007 May 10.

  PMID: 17493294 BACKGROUND

• Black DW, Wesner RB, Gabel J, Bowers W, Monahan P. Predictors of short-term treatment response in 66 patients with panic disorder. J Affect Disord. 1994 Apr;30(4):233-41. doi: 10.1016/0165-0327(94)90131-7.

  PMID: 8014323 BACKGROUND

• Angst J, Vollrath M. The natural history of anxiety disorders. Acta Psychiatr Scand. 1991 Nov;84(5):446-52. doi: 10.1111/j.1600-0447.1991.tb03176.x.

  PMID: 1776498 BACKGROUND

Study Officials

• Sang-Hyuk Lee, MD., PhD

  Professor at Bundang CHA medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Ju Kim, MD., PhD

CONTACT

82+31-780-5874; guswn10ve@gmail.com

Hye-Yeon Jung, MA

CONTACT

hychung980607@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Bundang CHA medical center

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: June 22, 2023
• Study Start: September 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: December 31, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08