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临床试验/NCT03199625
NCT03199625Unknown2 期

Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
96
试验地点
1
主要终点
Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research

研究概览

简要总结

Cognitive behavioral therapy (CBT), which includes cognitive therapy (CT) and behavioral therapy (BT), is the first-line treatment for patients with panic disorder (PD). However, the neural mechanism of CBT is unknown. The exploration of mechanism is of great significance for clinical strategy formulation. This study is proposed on the basis of our early PD and CBT neuroimaging studies, adopt the design of prospective randomized controlled intervention study, set up three time points: before the treatment(week 0), the initial treatment (week 4th), the plateau treatment (week 28th). With normal subjects as black control and antidepressant therapy as intervention comparison, this study set up CT and BT two intervention groups, respectively collect all the participants'symptomatological, psychological, cognitive function and brain imaging data (3D,DTI, fMRI in resting and tasks states) at week 0, week 4th and week 28th. This study is based on the advanced analysis methods we applied in the early study,including BOLD-fMRI, DTI, topological characteristics analysis of the whole brain network and Granger causality test etc. It is from the point of multiple levels(brain regions, circuits, whole brain), multimodal (structure, function) to comprehensively analysis the role of CT and BT for the function and structure of brain regions, circuits (mood regulating circuit and cognitive control network for emotion processing) and whole brain in patients with PD. Totally, we explore the target area, path and mechanism of CBT for emotion processing neural circuits in patients with PD, and combined with the clinical data we preliminarily explore the imaging biomarkers of different intervention methods which may predict therapeutic effect.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •meet DSM-5 and Mini-international neuropsychiatric interview (MINI) Chinese version panic disorder diagnosis;
  • •the age of 20-50 years old;
  • •Right handedness;
  • •patients to participate voluntarily, with the consent of their families, signed informed consent book.

排除标准

  • •neurological diseases or other mental illnesses;
  • •serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
  • •treatment by psychotropic medications,psychological treatment, electroconvulsive therapy or physical therapy within 3 months prior to the start of the trial;
  • •with contraindication for MRI
  • •pregnancy and lactation.

研究组 & 干预措施

Behavior Therapy group

Experimental

treatment with Behavior Therapy

干预措施: Behavior therapy (Behavioral)

Cognitive Therapy group

Experimental

treatment with Cognitive Therapy

干预措施: Cognitive therapy (Behavioral)

SSRI antidepressants

Active Comparator

treatment by SSRI antidepressant

干预措施: SSRI antidepressants (Drug)

结局指标

主要结局

Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research

时间窗: an expected average of 6 months

The 14-item version of the Hamilton Rating Scale for Anxiety (HAMA; Hamilton, 1959) will be used for measuring severity of depressive symptoms. Minimum and maximum possible values are respectively 0 and 56. Lower scores show more mild anxiety.

Magnetic Resonance Imaging

时间窗: Time Frame: an expected average of 6 months

次要结局

未报告次要终点

研究者

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun Wang

Nanjing Brain hospital

Nanjing Medical University

研究点 (1)

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