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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

January 15, 2009
August 19, 2012
July 2008
February 2009   (final data collection date for primary outcome measure)
score change of The Panic Disorder Severity Scale(PDSS) [ Time Frame: day 1 / 4 weeks/ 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00825136 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
A Study on Mental Health Care by Using Specific Vital Signs

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Panic Disorder
  • 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.
  • Active Comparator: relaxation
    The patients of this arm practice on-line muscle relaxation for 8 weeks.
    Intervention: Behavioral: relaxation
  • Experimental: relaxation & biofeedback
    The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks.
    Interventions:
    • Behavioral: relaxation
    • Behavioral: biofeedback (finger temperature biofeedback)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
May 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00825136
IRB 09707-001
Yes
Fong-Lin Jang, Chimei Medical Center
Chimei Medical Center
Not Provided
Study Director: Fong-Lin Jang, M.D. Chimei Medical Center
Chimei Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP