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

• ClinicalTrials.gov Identifier: NCT05911412
• Recruitment Status: Not yet recruiting
• First Posted: June 22, 2023
• Last Update Posted: August 25, 2023
• Sponsor: CHA University
• Collaborator: National Research Foundation of Korea
• Information provided by (Responsible Party): Sang-Hyuk Lee, CHA University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety Depression	Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: September 1, 2023
• Estimated Primary Completion Date: February 28, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

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.).

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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)
3. 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)
4. 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)
5. 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.
6. 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.
7. 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.
8. 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.
9. Change in FC measured with fMRI [ Time Frame: baseline, 8 weeks after treatment ]
   Change in functional connectivity (FC) in resting-state functional MRI (fMRI).

Secondary Outcome Measures :

1. The changes in the Korean version of Panic Disorder Severity Scale (PDSS). [ Time Frame: baseline, 8 week after treatment ]
   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.
2. The change in the Korean version of Albany Panic and Phobia Questionnaire (APPQ) [ Time Frame: baseline, 8 week after treatment ]
   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.
3. The change in the Korean version of the Beck Depression Inventory (BDI)-II [ Time Frame: baseline, 8 week after treatment ]
   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.
4. The change in the Korean version of the Beck Anxiety Inventory (BAI) [ Time Frame: baseline, 8 week after treatment ]
   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.
5. The change in the Korean version of the Penn State Worry Questionnaire (PSWQ) [ Time Frame: baseline, 8 week after treatment ]
   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.
6. The change in the Korean version of the Anxiety Sensitivity Inventory-Revised (ASI-R) [ Time Frame: baseline, 8 week after treatment ]
   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.
7. The change in the Self-Compassion Scale-Short Form (SCS-SF) [ Time Frame: baseline, 8 week after treatment ]
   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.
8. The change in the Concise Measure of Subjective Well-Being (COMOSWB) [ Time Frame: baseline, 8 week after treatment ]
   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.
9. The change in the Korean Burnout Syndrome Scale (KBOSS) [ Time Frame: baseline, 8 week after treatment ]
   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.
10. The change in the Korean version of the Grit Scale [ Time Frame: baseline, 8 week after treatment ]
    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.
11. side effects [ Time Frame: baseline, 2 week/4 week/8 week after treatment ]
    To evaluate the side effects through the interview

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Hyun-Ju Kim, MD., PhD; 82+31-780-5874; guswn10ve@gmail.com

Contact: Hye-Yeon Jung, MA; hychung980607@gmail.com

Sponsors and Collaborators

CHA University

National Research Foundation of Korea

Investigators

• Principal Investigator: Sang-Hyuk Lee, MD., PhD; Professor at Bundang CHA medical center

More Information

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• Responsible Party: Sang-Hyuk Lee, Professor at Bundang CHA medical center, CHA University
• ClinicalTrials.gov Identifier: NCT05911412
• Other Study ID Numbers: 2022-10-041-002
• First Posted: June 22, 2023
• Last Update Posted: August 25, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sang-Hyuk Lee, CHA University:

mindfulness-based cognitive therapy; mri; neuroscience

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders