A Brief Version of Biofeedback Therapy for Panic Disorder
Primary Purpose
Panic Disorder, Feedback, Psychological
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Biofeedback therapy
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring Psychiatry, psychological, psychotherapy, randomize, Biofeedback
Eligibility 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:
- The age is younger than 20 or older than 70 years.
- With psychotic symptoms or cognitive dysfunction.
- A major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction)
- Unable to read or understand the questionnaire
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
biofeedback group
medication group
Arm Description
biofeedback therapy
only medication treament
Outcomes
Primary Outcome Measures
Changes from baseline Panic Disorder Severity Scale (PDSS)
PDSS is a scale rating the severity of panic disorder. It is a 5-point Likert scale with 7 items. The scores range from 0 (lowest level of panic disorder) to 28 (highest level of panic disorder).
Secondary Outcome Measures
Scores of Patient Health Questionnaire-15 (PHQ-15)
PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress).
Scores of Health Anxiety Questionnaire (HAQ)
HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety).
Penn State Worry Questionnaire (PSWQ)
PSWQ is a scale rating the severity of worry. It is 5-point Likert scale with 16 items. The scores range from 1 (lowest level of worry) to 80 (highest level of worry).
Scores of WHOQOL-BREF
It is a self-report questionnaire measuring health-related quality of life. It is a 4-point Likert scale with 28 items, which belong to 5 domains (the overall, physical, psychological, social and environmental domains). The scores of each domain are usually normalized with 0-20 or 0-100.
Sheehan Function Inventory
It is a scale rating the function in various dimensions of work, social life, leisure activities, family life and family responsibilities.
Scores of Beck Depression Inventory-II (BDI-II)
BDI- II is a scale rating the severity of depression. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of depression) to 63 (highest level of depression).
Scores of Beck Anxiety Inventory (BAI)
BAI is a scale rating the severity of anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of anxiety) to 63 (highest level of anxiety).
Degree of Change in Physiological Parameters
ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured.
Full Information
NCT ID
NCT02826096
First Posted
July 5, 2016
Last Updated
April 19, 2021
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch
1. Study Identification
Unique Protocol Identification Number
NCT02826096
Brief Title
A Brief Version of Biofeedback Therapy for Panic Disorder
Official Title
A Brief Version of Biofeedback Therapy for Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2015 (Actual)
Primary Completion Date
April 18, 2021 (Actual)
Study Completion Date
April 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Feedback, Psychological
Keywords
Psychiatry, psychological, psychotherapy, randomize, Biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biofeedback group
Arm Type
Experimental
Arm Description
biofeedback therapy
Arm Title
medication group
Arm Type
No Intervention
Arm Description
only medication treament
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback therapy
Intervention Description
The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.
Primary Outcome Measure Information:
Title
Changes from baseline Panic Disorder Severity Scale (PDSS)
Description
PDSS is a scale rating the severity of panic disorder. It is a 5-point Likert scale with 7 items. The scores range from 0 (lowest level of panic disorder) to 28 (highest level of panic disorder).
Time Frame
week 0, week 3, week 6
Secondary Outcome Measure Information:
Title
Scores of Patient Health Questionnaire-15 (PHQ-15)
Description
PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress).
Time Frame
week 0, week 3, week 6
Title
Scores of Health Anxiety Questionnaire (HAQ)
Description
HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety).
Time Frame
week 0, week 3, week 6
Title
Penn State Worry Questionnaire (PSWQ)
Description
PSWQ is a scale rating the severity of worry. It is 5-point Likert scale with 16 items. The scores range from 1 (lowest level of worry) to 80 (highest level of worry).
Time Frame
week 0, week 3, week 6
Title
Scores of WHOQOL-BREF
Description
It is a self-report questionnaire measuring health-related quality of life. It is a 4-point Likert scale with 28 items, which belong to 5 domains (the overall, physical, psychological, social and environmental domains). The scores of each domain are usually normalized with 0-20 or 0-100.
Time Frame
week 0, week 3, week 6
Title
Sheehan Function Inventory
Description
It is a scale rating the function in various dimensions of work, social life, leisure activities, family life and family responsibilities.
Time Frame
week 0, week 3, week 6
Title
Scores of Beck Depression Inventory-II (BDI-II)
Description
BDI- II is a scale rating the severity of depression. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of depression) to 63 (highest level of depression).
Time Frame
week 0, week 3, week 6
Title
Scores of Beck Anxiety Inventory (BAI)
Description
BAI is a scale rating the severity of anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of anxiety) to 63 (highest level of anxiety).
Time Frame
week 0, week 3, week 6
Title
Degree of Change in Physiological Parameters
Description
ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured.
Time Frame
week 0, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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:
The age is younger than 20 or older than 70 years.
With psychotic symptoms or cognitive dysfunction.
A major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction)
Unable to read or understand the questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuan-Fu Lin, MD
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Douliu
State/Province
Yun-Lin
ZIP/Postal Code
640
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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A Brief Version of Biofeedback Therapy for Panic Disorder
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