Development of the Neuroimaging Biomarker-based Prediction Model of

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05911412
Study type	Interventional
Source	CHA University
Contact	Hyun-Ju Kim, MD., PhD
Phone	82+31-780-5874
Email	guswn10ve@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	September 1, 2023
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms