A Brief Version of Biofeedback Therapy for Panic Disorder

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder; Feedback, Psychological
• Intervention / Treatment: Behavioral: Biofeedback therapy

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
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Yun-Lin
    • Douliu, Yun-Lin, Taiwan, 640
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University Hospital, Yun-Lin Branch
• Investigators: Principal Investigator: Kuan-Fu Lin, MD, National Taiwan University Hospital, Yun-Lin branch

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2015
• Primary Completion (ACTUAL): April 18, 2021
• Study Completion (ACTUAL): April 18, 2021

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Psychiatry; psychotherapy; Biofeedback; psychological; randomize
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: 201511031RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No