NCT03199625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 27, 2017

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

June 20, 2017

Last Update Submit

June 23, 2017

Conditions

Panic Disorder

Keywords

cognitive-behavior therapymagnetic resonance imagingPanic Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Cognitive Therapy group

EXPERIMENTAL

treatment with Cognitive Therapy

Behavioral: Cognitive therapy

Behavior Therapy group

EXPERIMENTAL

treatment with Behavior Therapy

Behavioral: Behavior therapy

SSRI antidepressants

ACTIVE COMPARATOR

treatment by SSRI antidepressant

Drug: SSRI antidepressants

Interventions

Cognitive therapyBEHAVIORAL
Also known as: cognitive therapy(CT)
Cognitive Therapy group
Behavior therapyBEHAVIORAL
Also known as: Behavior therapy(BT)
Behavior Therapy group
SSRI antidepressantsDRUG
SSRI antidepressants

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral TherapyBehavior Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chun Wang, doctor

    Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Wang, doctor

CONTACT

86 15850566376fm51109@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nanjing Brain hospital

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 27, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

June 27, 2017

Record last verified: 2016-12

Locations

CN(1)