Clinical trial NCT05911412: Development of the Neuroimaging Biomarker-based Prediction Model of Anxiety-related Disorders: Effect of Mindfulness-based Cognitive Therapy Using Neuroscience on the Brain
Official title: Development of the Neuroimaging Biomarker-based Prediction Model of Anxiety-related Disorders and Novel Treatment Strategies: Effect of Mindfulness-based Cognitive Therapy Using Neuroscience on the Brain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Depression
Keywords: mindfulness-based cognitive therapy
mri
neuroscience
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2023-06-22
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: There are reports that mindfulness-based cognitive therapy (MBCT) techniques in patients with panic disorder or depression promote neuroplasticity changes in the brain, thereby restoring individual vulnerability to anxiety. This clinical study aims to develop a metacognitive task that improves existing MBCT as a new treatment that changes the function of anxiety or depression-specific neural circuits, and to explore neurological mechanisms and treatment-related factors.

This study was designed to enroll 64 participants, 32 in the NMBCT intervention and 32 in waitlist. This will allow 20% attrition and the Investigators anticipate 52 participants will complete the study. A sample size of 52 will achieve 80% power, given current effect size (cohen's d = 0.40, alpha = 0.05) estimates per aim.

Participants randomized to the NMBCT intervention or waitlist group will complete an 8-week NMBCT program conducted by a trained psychiatrist. The waitlist control group will maintain the blind for a treatment period from the baseline and then implement the NMBCT program on the NMBCT intervention group to those who agree.

Study data will be collected at 3 times for two groups: T1=1st week session (baseline); T2=8th week session; T3=6 months after baseline. All participants in the clinical study will undergo a total of two brain MRI tests within two weeks before and after visit 2 (T1, baseline) and visit 3 (T2, post-treatment, 8 weeks later).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in GMV measured with sMRI
timeFrame: baseline, 8 weeks after treatment
measure: Change in CT measured with sMRI
timeFrame: baseline, 8 weeks after treatment
measure: Change in SA measured with sMRI
timeFrame: baseline, 8 weeks after treatment
measure: Change LGI measured with sMRI
timeFrame: baseline, 8 weeks after treatment
measure: Change in FA measured with DTI
timeFrame: baseline, 8 weeks after treatment
measure: Change in MD measured with DTI
timeFrame: baseline, 8 weeks after treatment
measure: Change in AD measured with DTI
timeFrame: baseline, 8 weeks after treatment
measure: Change in RD measured with DTI
timeFrame: baseline, 8 weeks after treatment
measure: Change in FC measured with fMRI
timeFrame: baseline, 8 weeks after treatment
Secondary outcomes:
measure: The changes in the Korean version of Panic Disorder Severity Scale (PDSS).
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean version of Albany Panic and Phobia Questionnaire (APPQ)
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean version of the Beck Depression Inventory (BDI)-II
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean version of the Beck Anxiety Inventory (BAI)
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean version of the Penn State Worry Questionnaire (PSWQ)
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean version of the Anxiety Sensitivity Inventory-Revised (ASI-R)
timeFrame: baseline, 8 week after treatment
measure: The change in the Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: baseline, 8 week after treatment
measure: The change in the Concise Measure of Subjective Well-Being (COMOSWB)
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean Burnout Syndrome Scale (KBOSS)
timeFrame: baseline, 8 week after treatment
measure: The change in the Korean version of the Grit Scale
timeFrame: baseline, 8 week after treatment
measure: side effects
timeFrame: baseline, 2 week/4 week/8 week after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Professor at Bundang CHA medical center
name: Sang-Hyuk Lee, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Insel TR, Cuthbert BN. Medicine. Brain disorders? Precisely. Science. 2015 May 1;348(6234):499-500. doi: 10.1126/science.aab2358. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.