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

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ClinicalTrials.gov Identifier: NCT03199625
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Chun Wang, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Panic Disorder Behavioral: Cognitive therapy Behavioral: Behavior therapy Drug: SSRI antidepressants Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Therapy group
treatment with Cognitive Therapy
Behavioral: Cognitive therapy
Other Name: cognitive therapy(CT)

Experimental: Behavior Therapy group
treatment with Behavior Therapy
Behavioral: Behavior therapy
Other Name: Behavior therapy(BT)

Active Comparator: SSRI antidepressants
treatment by SSRI antidepressant
Drug: SSRI antidepressants



Primary Outcome Measures :
  1. Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research [ Time Frame: 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.

  2. Magnetic Resonance Imaging [ Time Frame: Time Frame: an expected average of 6 months ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199625


Contacts
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Contact: Chun Wang, doctor 86 15850566376 fm51109@163.com

Locations
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China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Principal Investigator: Chun Wang         
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Principal Investigator: Chun Wang, doctor Nanjing Medical University

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Responsible Party: Chun Wang, Nanjing Brain hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03199625     History of Changes
Other Study ID Numbers: 81571344
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: December 2016
Keywords provided by Chun Wang, Nanjing Medical University:
cognitive-behavior therapy
magnetic resonance imaging
Panic Disorder
Additional relevant MeSH terms:
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Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs