Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring - Full Text View

Sponsored by:	Chimei Medical Center
Information provided by:	Chimei Medical Center
ClinicalTrials.gov Identifier:	NCT00825136

Purpose

Internet plays a more and more important role in many applications of healthcare. Many researches on the integrations of internet and mental health care have been proposed in recent years. This project aims at the development of an online treatment system which combines the biofeedback therapy and the web technologies to treat the patients suffering from panic disorder with partial response to medications. This project also evaluates the efficacy of a new- designed wireless temperature biofeedback ring.

Condition	Intervention
Panic Disorder	Behavioral: finger temperature biofeedback

MedlinePlus related topics: Mental Health Panic Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Study on Mental Health Care by Using Specific Vital Signs

Further study details as provided by Chimei Medical Center:

Primary Outcome Measures:

score change of The Panic Disorder Severity Scale(PDSS) [ Time Frame: day 1 / 4 weeks/ 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

score change of MOS 36-Item Short-Form Health Survey (SF-36) [ Time Frame: day 1 / 4 weeks/ 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
muscle relaxation: Active Comparator The patients of this arm practice on-line muscle relaxation every day and complete some self rating scales via internet browser.	Behavioral: finger temperature biofeedback patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every week.
muscle relaxation with biofeedback: Experimental The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day and complete some self rating scales via internet browser.	Behavioral: finger temperature biofeedback patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every week.

Detailed Description:

The participants should be chronic panic patients. They login an web-based server and practice muscle relaxation on-line every day. There will be two two parallel groups: one group practicing muscle relaxation only and the other practicing muscle relaxation with finger surface temperature monitor through a wireless biofeedback ring.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The participant must fulfill DSM-IV criteria for panic disorder.
The participant must be between 18 and 60 years of age.
The participant must have panic disorder as the primary problem.
If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 2 months before starting treatment, and b) the participant have to agree to keep the dosage constant for 1 month after starting treatment.
If the participant was already in therapy, the contact must have lasted at least 6 months and not be based on cognitive behavior therapy.
All participants have access to a computer with an Internet connection.

Exclusion Criteria:

The participant suffers from any other psychiatric disorder in immediate need of treatment.
The participant fulfills DSM-IV criteria for major depression.
The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. The participant has alcoholism.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825136

Contacts

Contact: Fong-Lin Jang, M.D.

886-929-047535

jfl5124@gmail.com

Locations

Taiwan
Psychiatry Department, Chimei Medical Center	Recruiting
Tainan, Taiwan, 700

Sponsors and Collaborators

Chimei Medical Center

Investigators

Study Director:

Fong-Lin Jang, M.D.

Chimei Medical Center

More Information

No publications provided

Responsible Party:	Chi Mei Medical Center ( Fong-Lin Jang )
Study ID Numbers:	IRB 09707-001
Study First Received:	January 15, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00825136 History of Changes
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Chimei Medical Center:

panic disorder
temperature biofeedback
internet

Study placed in the following topic categories:

Panic Disorder
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Panic Disorder
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 07, 2009