ClinicalTrials.gov
ClinicalTrials.gov Menu

A Brief Version of Biofeedback Therapy for Panic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02826096
Recruitment Status : Unknown
Verified July 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. It is a randomized controlled design. The severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or not) were measured before and after the six week duration. Besides, the severity of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.

Condition or disease Intervention/treatment Phase
Panic Disorder Feedback, Psychological Behavioral: Biofeedback therapy Not Applicable

Detailed Description:
The purpose of this study is trying to find out whether our newly developed brief version of biofeedback is an effective treatment approach for panic disorder. At the same time, the investigators want to clarify the change of bio- and psycho- indices present through the process. Patient recently experienced panic attacks are recruited in this study. The diagnosis of "Panic Disorder" is made by psychiatrists according to The Diagnostic and Statistical Manual of Mental Disorders(DSM-5) criteria. Subjects are randomly assigned to medication group or biofeedback therapy. The biofeedback therapy is conducted by psychologists following the structure way. Every subject will be measured both the bio and psycho indices on week 0, 3, and 6 under 6-week observation. In the end of the study, the investigators hope to analyze and clarify the treatment effects of our design, and also to exam the meanings of these indices, in order to find out an effective treatment approach.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Brief Version of Biofeedback Therapy for Panic Disorder
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder

Arm Intervention/treatment
Experimental: biofeedback group
biofeedback therapy
Behavioral: Biofeedback therapy
The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.

No Intervention: medication group
only medication treament



Primary Outcome Measures :
  1. Panic Disorder Severity Scale(PDSS) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

inclusion criteria: The panic disorder cases of the National Taiwan University Hospital Yunlin Branch Psychiatric outpatient department (Huwei, Douliou) have more than one time of panic attack in nearly three months.

exclusion criteria:

  1. The age is younger than 20 or older than 70 years.
  2. With psychotic symptoms or cognitive dysfunction.
  3. A major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction)
  4. Unable to read or understand the questionnaire

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): NCT02826096


Contacts
Contact: hong-yeh chang 886-5-5323911 ext 7124 Y00650@ms1.ylh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Dou-Liou, Yun-Lin, Taiwan, 640
Contact: Kuan-Fu Lin, MD    866-5-5323911 ext 7106    Trumansays@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Kuan-Fu Lin, MD National Taiwan University Hospital, Yun-Lin Branch

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02826096     History of Changes
Other Study ID Numbers: 201511031RIND
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Taiwan University Hospital:
Psychiatry
psychological
psychotherapy
randomize
Biofeedback

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders