NCT02826096

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

5.3 years

First QC Date

July 5, 2016

Last Update Submit

April 19, 2021

Conditions

Keywords

PsychiatrypsychologicalpsychotherapyrandomizeBiofeedback

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

EXPERIMENTAL

biofeedback therapy

Behavioral: Biofeedback therapy

medication group

NO INTERVENTION

only 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.

biofeedback group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Kuan-Fu Lin, MD

    National Taiwan University Hospital, Yun-Lin Branch

    PRINCIPAL INVESTIGATOR

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

Locations