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.

Study Overview

• Status: Terminated
• Conditions: Panic Disorder
• Intervention / Treatment: Behavioral: relaxation; Behavioral: biofeedback (finger temperature biofeedback)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
score change of The Panic Disorder Severity Scale(PDSS)	day 1 / 4 weeks/ 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
score change of MOS 36-Item Short-Form Health Survey (SF-36)	day 1 / 4 weeks/ 8 weeks

Collaborators and Investigators

• Sponsor: Chimei Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (Estimate): January 19, 2009

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: August 19, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Panic Disorder; Internet; Temperature Biofeedback
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: IRB 09707-001