Anxiety DepressionNCT05911412
Development of the Neuroimaging Biomarker-based Prediction Model of Anxiety-related Disorders: Effect of Mindfulness-based Cognitive Therapy Using Neuroscience on the Brain
A study testing Mindfulness-based cognitive therapy using neuroscience (NMBCT) in people with Anxiety Depression, run by CHA University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Mindfulness-based cognitive therapy using neuroscience (NMBCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Hye-Yeon Jung, MA contact
About this study
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
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.
Read the 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).
- Conditions
- Anxiety Depression
- Being tested
- Mindfulness-based cognitive therapy using neuroscience (NMBCT)
- Keywords
- mindfulness-based cognitive therapy, mri, neuroscience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive therapy using neuroscience (NMBCT)Behavioural
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.).
| Study group | Role | What they receive |
|---|---|---|
| NMBCT intervention | Experimental | Participants in this arm enter the 8-week NMBCT course immediately after the baseline visit. Receives: 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. Receives: Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GMV measured with sMRI
Change in gray matter volume (GMV) in mm3 measured with structural MRI (sMRI)
Measured: baseline, 8 weeks after treatment
Change in CT measured with sMRI
Change in cortical thickness (CT) in mm measured with structural MRI (sMRI)
Measured: baseline, 8 weeks after treatment
Change in SA measured with sMRI
Change in surface area (SA) in mm2 measured with structural MRI (sMRI)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 8 weeks after treatment
Change in FC measured with fMRI
Change in functional connectivity (FC) in resting-state functional MRI (fMRI).
Measured: baseline, 8 weeks after treatment
Secondary outcomes (11)
The changes in the Korean version of Panic Disorder Severity Scale (PDSS).
To assess panic symptom changes after the 8th week of treatment using the Korean version of the Panic Disorder Severity Scale (PDSS). The PDSS consists of 7 items coded on a 5-point scale (0-4). The total scores ranged from 0 to 28. The higher the total scores, the higher the panic symptom severity.
Measured: baseline, 8 week after treatment
The change in the Korean version of Albany Panic and Phobia Questionnaire (APPQ)
To assess agoraphobia symptoms changes after the 8th week of treatment, the Korean Albany Panic and Phobia Questionnaire (APPQ) was used. The APPQ contains 27 items coded on a 9-point scale (0-8). And it can be used to assess interoceptive fear (8 items), social phobia (10 items), and agoraphobia (9 items). The higher each subscale's total score, the poorer the phobic symptom.
Measured: baseline, 8 week after treatment
The change in the Korean version of the Beck Depression Inventory (BDI)-II
To assess depressive symptoms changes after the 8th week of treatment, the Beck Depression Inventory (BDI)-II was used. The 21 self-administered items that comprise the BDI-II were scored from a range of 0 to 3, with the maximum score being 63. The higher the total scores, the more severe the depressive symptom.
Measured: baseline, 8 week after treatment
The change in the Korean version of the Beck Anxiety Inventory (BAI)
To assess anxiety symptoms changes after the 8th week of treatment, the Beck Anxiety Inventory (BAI) was used. The 21 self-administered items that comprise the BAI were scored from a range of 0 to 3, with the maximum score being 63. The higher the total scores, the more severe the anxiety symptom.
Measured: baseline, 8 week after treatment
The change in the Korean version of the Penn State Worry Questionnaire (PSWQ)
To assess the frequency, intensity, and uncontrollability of pathological worry symptoms changes after the 8th week of treatment, the Penn State Worry Questionnaire (PSWQ) was used. The 16 self-administered items that comprise the PSWQ were scored from a range of 1 (not at all typical) to 5 (very typical), with the maximum score being 80. The higher the total scores, the more severe the pathological worry symptom.
Measured: baseline, 8 week after treatment
The change in the Korean version of the Anxiety Sensitivity Inventory-Revised (ASI-R)
To assess the trait anxiety sensitivity levels changes after the 8th week of treatment, the Korean version of the Anxiety Sensitivity Inventory-Revised (ASI-R) was used. The 36-item ASI-R consists of (1) fear of respiratory symptoms, (2) publicly observable anxiety reactions, (3) cardiovascular symptoms, and (4) cognitive dyscontrol. Total scores range from 0 to 144. The higher the total scores, the higher the anxiety sensitivity levels.
Measured: baseline, 8 week after treatment
The change in the Self-Compassion Scale-Short Form (SCS-SF)
To assess the changes in self-compassion levels after the 8th week of treatment, the Self-Compassion Scale-Short Form (SCS-SF) was used. The 12-item SCS-SF consists of self-kindness (2 items), self-judgment (2 items), common humanity (2 items), isolation subscales (2 items), mindfulness (2 items), and over-identified (2 items). Total scores range from 12 to 60. The reverse score of the negative subscale items (e.g., self-judgment, isolation, and over-identification) was used to compute total self-compassion scores. The higher the total scores, the higher the self-compassion levels.
Measured: baseline, 8 week after treatment
The change in the Concise Measure of Subjective Well-Being (COMOSWB)
To evaluate the changes in subjective well-being levels after the 8th week of treatment, the Concise Measure of Subjective Well-Being (COMOSWB) was used. The COMOSWB consists of life satisfaction, positive affect, and negative affect. The 9-item was scored from a range of 1 (strongly disagree or never) to 7 (strongly agree or always). Total scores range from 7 to 63. The higher the total scores, the higher the subjective well-being levels.
Measured: baseline, 8 week after treatment
The change in the Korean Burnout Syndrome Scale (KBOSS)
To evaluate the changes in burnout symptoms levels after the 8th week of treatment, the Korean Burnout Syndrome Scale (KBOSS) was used. The 12-item KBOSS consists of exhaustion (4 items), cynicism (4 items), and inefficacy (4 items). The 16-item was scored from a range of 1 (strongly disagree) to 7 (strongly agree), with the maximum score being 84. Total scores range from 12 to 84. The higher the total scores, the more severe the burn-out symptom.
Measured: baseline, 8 week after treatment
The change in the Korean version of the Grit Scale
To evaluate the changes in grit levels after the 8th week of treatment, the Korean version of the Grit Scale was used. The 12-item of the Korean version of the Grit scale was scored from a range of 0 (strongly disagree) to 5 (strongly agree), with the maximum score being 60. The higher the total scores, the higher levels of grit.
Measured: baseline, 8 week after treatment
side effects
To evaluate the side effects through the interview
Measured: baseline, 2 week/4 week/8 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sang-Hyuk Lee, CHA University
- Investigators
- Sang-Hyuk Lee, MD., PhD, Principal investigator, Professor at Bundang CHA medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911412
- Sponsor's protocol ID
- 2022-10-041-002
- Status last verified
- Aug 2023
- First submitted
- 23 Feb 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35259523Yun 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.
PubMed 32040561Yook 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.
PubMed 18552629Williams 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.
PubMed 27150382Varghese 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.
PubMed 30733585Tang 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.
PubMed 25783612Stein 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.
PubMed 22504417Sun 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.
PubMed 29165048Shear 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.
PubMed 17623395Roy-Byrne PP, Craske MG, Stein MB. Panic disorder. Lancet. 2006 Sep 16;368(9540):1023-32. doi: 10.1016/S0140-6736(06)69418-X.
PubMed 16980119Park 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.
PubMed 32988740Park 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.
PubMed 29662558Liang 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.
PubMed 30275937Klauke 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.
PubMed 20112245Kim 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.
PubMed 19242985
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05911412
- Acronym / sponsor ID
- 2022-10-041-002
- Conditions
- Anxiety Depression
- Keywords
- mindfulness-based cognitive therapy, mri, neuroscience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMBCT intervention | Experimental | Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)Participants in this arm enter the 8-week NMBCT course immediately after the baseline visit. |
| Waitlist | Experimental | Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.). | Behavioural | NMBCT intervention, Waitlist |
Primary outcome
Change in GMV measured with sMRI
Time frame: baseline, 8 weeks after treatment
Change in gray matter volume (GMV) in mm3 measured with structural MRI (sMRI)
Change in CT measured with sMRI
Time frame: baseline, 8 weeks after treatment
Change in cortical thickness (CT) in mm measured with structural MRI (sMRI)
Change in SA measured with sMRI
Time frame: baseline, 8 weeks after treatment
Change in surface area (SA) in mm2 measured with structural MRI (sMRI)
Change LGI measured with sMRI
Time frame: baseline, 8 weeks after treatment
Change in local gyrification index (LGI), ranged from 0 to 1, measured with structural MRI (sMRI)
Change in FA measured with DTI
Time frame: baseline, 8 weeks after treatment
Change in fractional anisotropy (FA), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.
Change in MD measured with DTI
Time frame: baseline, 8 weeks after treatment
Change in mean diffusivity (MD), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.
Change in AD measured with DTI
Time frame: baseline, 8 weeks after treatment
Change in axial diffusivity (AD), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.
Change in RD measured with DTI
Time frame: baseline, 8 weeks after treatment
Change in radial diffusivity (AD), ranged from 0 to 1, measured with diffusion tensor imaging (DTI) and T1-weighted MR image.
Change in FC measured with fMRI
Time frame: baseline, 8 weeks after treatment
Change in functional connectivity (FC) in resting-state functional MRI (fMRI).
11 secondary outcomes
The changes in the Korean version of Panic Disorder Severity Scale (PDSS).
Time frame: baseline, 8 week after treatment
The change in the Korean version of Albany Panic and Phobia Questionnaire (APPQ)
Time frame: baseline, 8 week after treatment
The change in the Korean version of the Beck Depression Inventory (BDI)-II
Time frame: baseline, 8 week after treatment
The change in the Korean version of the Beck Anxiety Inventory (BAI)
Time frame: baseline, 8 week after treatment
The change in the Korean version of the Penn State Worry Questionnaire (PSWQ)
Time frame: baseline, 8 week after treatment
The change in the Korean version of the Anxiety Sensitivity Inventory-Revised (ASI-R)
Time frame: baseline, 8 week after treatment
The change in the Self-Compassion Scale-Short Form (SCS-SF)
Time frame: baseline, 8 week after treatment
The change in the Concise Measure of Subjective Well-Being (COMOSWB)
Time frame: baseline, 8 week after treatment
The change in the Korean Burnout Syndrome Scale (KBOSS)
Time frame: baseline, 8 week after treatment
The change in the Korean version of the Grit Scale
Time frame: baseline, 8 week after treatment
side effects
Time frame: baseline, 2 week/4 week/8 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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- Background: PubMed 22504417Stein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hye-Yeon Jung, MA contact
Sang-Hyuk Lee, MD., PhD principal investigator
Professor at Bundang CHA medical center
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive therapy using neuroscience (NMBCT) in people with Anxiety Depression, run by CHA University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Ju Kim, MD., PhD (82+31-780-5874, guswn10ve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GMV measured with sMRI (time frame: baseline, 8 weeks after treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911412, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.