Clinical trial NCT02826096: A Brief Version of Biofeedback Therapy for Panic Disorder
Official title: A Brief Version of Biofeedback Therapy for Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Feedback, Psychological
Keywords: Psychiatry
psychological
psychotherapy
randomize
Biofeedback
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2016-07-07
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Changes from baseline Panic Disorder Severity Scale (PDSS)
timeFrame: week 0, week 3, week 6
Secondary outcomes:
measure: Scores of Patient Health Questionnaire-15 (PHQ-15)
timeFrame: week 0, week 3, week 6
measure: Scores of Health Anxiety Questionnaire (HAQ)
timeFrame: week 0, week 3, week 6
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: week 0, week 3, week 6
measure: Scores of WHOQOL-BREF
timeFrame: week 0, week 3, week 6
measure: Sheehan Function Inventory
timeFrame: week 0, week 3, week 6
measure: Scores of Beck Depression Inventory-II (BDI-II)
timeFrame: week 0, week 3, week 6
measure: Scores of Beck Anxiety Inventory (BAI)
timeFrame: week 0, week 3, week 6
measure: Degree of Change in Physiological Parameters
timeFrame: week 0, week 6
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital
state: Yun-Lin
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Kuan-Fu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: