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Completed

NCT Number: NCT02826096

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Feedback, Psychological Mental Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Douliu, Yun-Lin, 640, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

biofeedback therapy

Behavioral

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

Primary outcomes

  1. Changes from baseline Panic Disorder Severity Scale (PDSS)

    Time frame: week 0, week 3, week 6

    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).

Secondary outcomes

  1. Scores of Patient Health Questionnaire-15 (PHQ-15)

    Time frame: week 0, week 3, week 6

    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).

  2. Scores of Health Anxiety Questionnaire (HAQ)

    Time frame: week 0, week 3, week 6

    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).

  3. Penn State Worry Questionnaire (PSWQ)

    Time frame: week 0, week 3, week 6

    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).

  4. Scores of WHOQOL-BREF

    Time frame: week 0, week 3, week 6

    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.

  5. Sheehan Function Inventory

    Time frame: week 0, week 3, week 6

    It is a scale rating the function in various dimensions of work, social life, leisure activities, family life and family responsibilities.

  6. Scores of Beck Depression Inventory-II (BDI-II)

    Time frame: week 0, week 3, week 6

    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).

  7. Scores of Beck Anxiety Inventory (BAI)

    Time frame: week 0, week 3, week 6

    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).

  8. Degree of Change in Physiological Parameters

    Time frame: week 0, week 6

    ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University Hospital, Yun-Lin Branch

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2016
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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