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

CHA University

Status: Not yet enrolling

Conditions: Anxiety Depression

Treatments: Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05911412

2022-10-041-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 64 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

NMBCT intervention

Experimental group

Description:

Participants in this arm enter the 8-week NMBCT course immediately after the baseline visit.

Treatment:

Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)

Waitlist

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based cognitive therapy using neuroscience (NMBCT)