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

NCT ID: NCT03199625

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cognitive Therapy group

treatment with Cognitive Therapy

Group Type EXPERIMENTAL

Cognitive therapy

Intervention Type BEHAVIORAL

Behavior Therapy group

treatment with Behavior Therapy

Group Type EXPERIMENTAL

Behavior therapy

Intervention Type BEHAVIORAL

SSRI antidepressants

treatment by SSRI antidepressant

Group Type ACTIVE_COMPARATOR

SSRI antidepressants

Intervention Type DRUG

Interventions

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Cognitive therapy

Intervention Type BEHAVIORAL

Behavior therapy

Intervention Type BEHAVIORAL

SSRI antidepressants

Intervention Type DRUG

Other Intervention Names

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cognitive therapy(CT) Behavior therapy(BT)

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chun Wang

Nanjing Brain hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University

Locations

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Nanjing Brain Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chun Wang, doctor

Role: CONTACT

86 15850566376

Other Identifiers

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81571344

Identifier Type: -

Identifier Source: org_study_id

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