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

N

Nanjing Medical University

Status and phase

Unknown
Phase 2

Conditions

Panic Disorder

Treatments

Behavioral: Behavior therapy
Drug: SSRI antidepressants
Behavioral: Cognitive therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03199625
81571344

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 3 patient groups

Cognitive Therapy group
Experimental group
Description:
treatment with Cognitive Therapy
Treatment:
Behavioral: Cognitive therapy
Behavior Therapy group
Experimental group
Description:
treatment with Behavior Therapy
Treatment:
Behavioral: Behavior therapy
SSRI antidepressants
Active Comparator group
Description:
treatment by SSRI antidepressant
Treatment:
Drug: SSRI antidepressants

Trial contacts and locations

1

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Central trial contact

Chun Wang, doctor

Data sourced from clinicaltrials.gov

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