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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Change in GMV measured with sMRI
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in GMV measured with sMRI
时间窗: baseline, 8 weeks after treatment
Change in gray matter volume (GMV) in mm3 measured with structural MRI (sMRI)
Change LGI measured with sMRI
时间窗: 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
时间窗: 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 RD measured with DTI
时间窗: 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
时间窗: baseline, 8 weeks after treatment
Change in functional connectivity (FC) in resting-state functional MRI (fMRI).
Change in CT measured with sMRI
时间窗: baseline, 8 weeks after treatment
Change in cortical thickness (CT) in mm measured with structural MRI (sMRI)
Change in SA measured with sMRI
时间窗: baseline, 8 weeks after treatment
Change in surface area (SA) in mm2 measured with structural MRI (sMRI)
Change in MD measured with DTI
时间窗: 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
时间窗: 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.
次要结局
- The changes in the Korean version of Panic Disorder Severity Scale (PDSS).(baseline, 8 week after treatment)
- The change in the Korean version of Albany Panic and Phobia Questionnaire (APPQ)(baseline, 8 week after treatment)
- The change in the Korean version of the Beck Depression Inventory (BDI)-II(baseline, 8 week after treatment)
- The change in the Korean version of the Beck Anxiety Inventory (BAI)(baseline, 8 week after treatment)
- The change in the Korean version of the Penn State Worry Questionnaire (PSWQ)(baseline, 8 week after treatment)
- The change in the Korean version of the Anxiety Sensitivity Inventory-Revised (ASI-R)(baseline, 8 week after treatment)
- The change in the Korean Burnout Syndrome Scale (KBOSS)(baseline, 8 week after treatment)
- The change in the Korean version of the Grit Scale(baseline, 8 week after treatment)
- The change in the Self-Compassion Scale-Short Form (SCS-SF)(baseline, 8 week after treatment)
- The change in the Concise Measure of Subjective Well-Being (COMOSWB)(baseline, 8 week after treatment)
- side effects(baseline, 2 week/4 week/8 week after treatment)
研究者
Sang-Hyuk Lee
Professor at Bundang CHA medical center
CHA University