Panic Disorder Clinical Trial
Official title:
A Brief Version of Biofeedback Therapy for Panic Disorder
Verified date | April 2021 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Douliu | Yun-Lin |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Taiwan University Hospital, Yun-Lin Branch |
Taiwan,
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 |
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