Development of the Neuroimaging Biomarker-based Prediction Model of Anxiety-related Disorders: Effect of Mindfulness-based Cognitive Therapy Using Neuroscience on the Brain
NCT ID: NCT05911412
Last Updated: 2023-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
64 participants
INTERVENTIONAL
2023-09-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigating Neural Response Variability as a Single-patient Predictor of Successful CBT in Clinical Psychiatry
NCT04191811
Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
NCT02226042
Real-time fMRI Neurofeedback for Mild/Moderate Depression
NCT05025904
Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety
NCT03084042
Scrutinizing and Promoting Mindfulness Via New Technologies
NCT03148678
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NMBCT intervention
Participants in this arm enter the 8-week NMBCT course immediately after the baseline visit.
Mindfulness-based cognitive therapy using neuroscience (NMBCT)
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.).
Waitlist
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.
Mindfulness-based cognitive therapy using neuroscience (NMBCT)
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.).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness-based cognitive therapy using neuroscience (NMBCT)
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.).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Research Foundation of Korea
OTHER
CHA University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sang-Hyuk Lee
Professor at Bundang CHA medical center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sang-Hyuk Lee, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Professor at Bundang CHA medical center
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Insel TR, Cuthbert BN. Medicine. Brain disorders? Precisely. Science. 2015 May 1;348(6234):499-500. doi: 10.1126/science.aab2358. No abstract available.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-10-041-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.