Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring

This study has been terminated.
(The main limitations were the small sample size and low completion rate.)
Sponsor:
Information provided by (Responsible Party):
Fong-Lin Jang, Chimei Medical Center
ClinicalTrials.gov Identifier:
NCT00825136
First received: January 15, 2009
Last updated: August 19, 2012
Last verified: August 2012
  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: relaxation
Behavioral: biofeedback (finger temperature biofeedback)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study on Mental Health Care by Using Specific Vital Signs

Resource links provided by NLM:


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 ]

Enrollment: 10
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: relaxation
The patients of this arm practice on-line muscle relaxation for 8 weeks.
Behavioral: relaxation
Participants were asked to log in the system to keep the muscle relaxation program every day and complete some self-rating scales on browser every week.
Experimental: relaxation & biofeedback
The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks.
Behavioral: relaxation
Participants were asked to log in the system to keep the muscle relaxation program every day and complete some self-rating scales on browser every week.
Behavioral: biofeedback (finger temperature biofeedback)
Participants were asked to log in the system to keep the muscle relaxation program plus finger temperature biofeedback every day and 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:

  1. The participant must fulfill DSM-IV criteria for panic disorder.
  2. The participant must be between 18 and 60 years of age.
  3. The participant must have panic disorder as the primary problem.
  4. 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.
  5. If the participant was already in therapy, the contact must have lasted at least 6 months and not be based on cognitive behavior therapy.
  6. All participants have access to a computer with an Internet connection.

Exclusion Criteria:

  1. The participant suffers from any other psychiatric disorder in immediate need of treatment.
  2. The participant fulfills DSM-IV criteria for major depression.
  3. The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. The participant has alcoholism.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Taiwan
Psychiatry Department, Chimei Medical Center
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: Fong-Lin Jang, Department of Psychiatry, Chimei Medical Center
ClinicalTrials.gov Identifier: NCT00825136     History of Changes
Other Study ID Numbers: IRB 09707-001
Study First Received: January 15, 2009
Last Updated: August 19, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chimei Medical Center:
Panic Disorder
Temperature Biofeedback
Internet

Additional relevant MeSH terms:
Disease
Panic Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014