A Brief Version of Biofeedback Therapy for Panic Disorder
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2015
CompletedFirst Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2021
CompletedApril 21, 2021
April 1, 2021
5.3 years
July 5, 2016
April 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Scores of Patient Health Questionnaire-15 (PHQ-15)
week 0, week 3, week 6
Scores of Health Anxiety Questionnaire (HAQ)
week 0, week 3, week 6
Penn State Worry Questionnaire (PSWQ)
week 0, week 3, week 6
Scores of WHOQOL-BREF
week 0, week 3, week 6
Sheehan Function Inventory
week 0, week 3, week 6
- +3 more secondary outcomes
Study Arms (2)
biofeedback group
EXPERIMENTALbiofeedback therapy
medication group
NO INTERVENTIONonly medication treament
Interventions
The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Douliu, Yun-Lin, 640, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuan-Fu Lin, MD
National Taiwan University Hospital, Yun-Lin Branch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 7, 2016
Study Start
December 21, 2015
Primary Completion
April 18, 2021
Study Completion
April 18, 2021
Last Updated
April 21, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share