A Brief Version of Biofeedback Therapy for Panic Disorder

NCT ID: NCT02826096

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-21
• Study Completion Date: 2021-04-18

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.

Conditions

Panic Disorder; Feedback, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

biofeedback group

biofeedback therapy

Group Type: EXPERIMENTAL

Biofeedback therapy

Intervention Type: BEHAVIORAL

The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.

medication group

only medication treament

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital, Yun-Lin Branch

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuan-Fu Lin, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Yun-Lin Branch

Locations

National Taiwan University Hospital

Douliu, Yun-Lin, Taiwan

Countries

Taiwan

Other Identifiers

201511031RIND

Identifier Type: -

Identifier Source: org_study_id