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

Panic Disorder Clinical Trial

Official title:

A Study on Mental Health Care by Using Specific Vital Signs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00825136
• Other study ID #: IRB 09707-001
• Status: Terminated
• Phase: N/A
• First received: January 15, 2009
• Last updated: August 19, 2012
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2012
• Source: Chimei Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Psychiatry Department, Chimei Medical Center	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score change of The Panic Disorder Severity Scale(PDSS)		day 1 / 4 weeks/ 8 weeks	No
Secondary	score change of MOS 36-Item Short-Form Health Survey (SF-36)		day 1 / 4 weeks/ 8 weeks	No