Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
Primary Purpose
Panic Disorder
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cognitive therapy
Behavior therapy
SSRI antidepressants
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring cognitive-behavior therapy, magnetic resonance imaging, Panic Disorder
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.
Sites / Locations
- Nanjing Brain HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Cognitive Therapy group
Behavior Therapy group
SSRI antidepressants
Arm Description
treatment with Cognitive Therapy
treatment with Behavior Therapy
treatment by SSRI antidepressant
Outcomes
Primary Outcome Measures
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.
Magnetic Resonance Imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT03199625
First Posted
June 20, 2017
Last Updated
June 23, 2017
Sponsor
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03199625
Brief Title
Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
Official Title
Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
cognitive-behavior therapy, magnetic resonance imaging, Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Therapy group
Arm Type
Experimental
Arm Description
treatment with Cognitive Therapy
Arm Title
Behavior Therapy group
Arm Type
Experimental
Arm Description
treatment with Behavior Therapy
Arm Title
SSRI antidepressants
Arm Type
Active Comparator
Arm Description
treatment by SSRI antidepressant
Intervention Type
Behavioral
Intervention Name(s)
Cognitive therapy
Other Intervention Name(s)
cognitive therapy(CT)
Intervention Type
Behavioral
Intervention Name(s)
Behavior therapy
Other Intervention Name(s)
Behavior therapy(BT)
Intervention Type
Drug
Intervention Name(s)
SSRI antidepressants
Primary Outcome Measure Information:
Title
Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research
Description
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.
Time Frame
an expected average of 6 months
Title
Magnetic Resonance Imaging
Time Frame
Time Frame: an expected average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Wang, doctor
Phone
86 15850566376
Email
fm51109@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Wang, doctor
Organizational Affiliation
Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Wang
12. IPD Sharing Statement
Learn more about this trial
Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
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