A Brief Version of Biofeedback Therapy for Panic Disorder

Panic Disorder Clinical Trial

Official title:

A Brief Version of Biofeedback Therapy for Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826096
• Other study ID #: 201511031RIND
• Status: Completed
• Phase: N/A
• Start date: December 21, 2015
• Est. completion date: April 18, 2021

Study information

• Verified date: April 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 18, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Feedback, Psychological
• Panic Disorder

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Douliu	Yun-Lin

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University Hospital, Yun-Lin Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	week 0, week 3, week 6
Secondary	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).	week 0, week 3, week 6
Secondary	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).	week 0, week 3, week 6
Secondary	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).	week 0, week 3, week 6
Secondary	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.	week 0, week 3, week 6
Secondary	Sheehan Function Inventory	It is a scale rating the function in various dimensions of work, social life, leisure activities, family life and family responsibilities.	week 0, week 3, week 6
Secondary	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).	week 0, week 3, week 6
Secondary	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).	week 0, week 3, week 6
Secondary	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.	week 0, week 6