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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Depression
• Intervention / Treatment: Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyun-Ju Kim, MD., PhD; Phone Number: 82+31-780-5874; Email: guswn10ve@gmail.com
• Study Contact Backup: Name: Hye-Yeon Jung, MA; Email: hychung980607@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMBCT intervention; Participants in this arm enter the 8-week NMBCT course immediately after the baseline visit.	Behavioral: 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.).
Experimental: 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.	Behavioral: 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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	baseline, 8 week after treatment
side effects	To evaluate the side effects through the interview	baseline, 2 week/4 week/8 week after treatment

Collaborators and Investigators

• Sponsor: CHA University
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Sang-Hyuk Lee, MD., PhD, Professor at Bundang CHA medical center

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: mri; neuroscience; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022-10-041-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No