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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive therapy
* Behavioral: Behavior therapy
* Drug: SSRI antidepressants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Therapy group<br>treatment with Cognitive Therapy | Behavioral: Cognitive therapy<br> <br> * Other names: cognitive therapy(CT);|
| Experimental: Behavior Therapy group<br>treatment with Behavior Therapy | Behavioral: Behavior therapy<br> <br> * Other names: Behavior therapy(BT);|
| Active Comparator: SSRI antidepressants<br>treatment by SSRI antidepressant | Drug: SSRI antidepressants<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research | 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. | an expected average of 6 months | 
| Magnetic Resonance Imaging |  | Time Frame: an expected average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive-behavior therapy, magnetic resonance imaging, Panic Disorder