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

Panic Disorder Clinical Trial

Official title:

Muscle Relaxation With Biofeedback Via Internet for Panic disorder-a Randomized Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01671033
• Other study ID #: IRB 09902-006
• Status: Terminated
• Phase: N/A
• First received: August 20, 2012
• Last updated: August 22, 2012
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2010
• Source: Chimei Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

From the scarce literature it showed that computer/internet-aided cognitive behavior therapy (CBT) was superior to waitlist and placebo assignment across outcome measures, and the effects of computer/internet-aided CBT were equal to therapist-delivered treatment across anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based relaxation with biofeedback treatment for panic disorder.

Description:

All participants had access to a computer with an internet connection and received the treatment via internet.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. The participant must fulfill DSM-IV criteria for panic disorder.

2. The participant must be between 20 and 60 years of age.

3. The participant must have the Panic Disorder Severity Scale(PDSS) score ?8.

4. If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 6 weeks before starting treatment, and b) the participant have to agree to keep the dosage constant for 2 months after starting treatment.

5. If the participant was already in therapy, the contact must have lasted at least 3 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 or substance dependence.

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:
• 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 day or every week.
• Muscle Relaxation
Patients with panic disorder practice muscle relaxation via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.

Locations

Country	Name	City	State
Taiwan	Chimei Medical Center	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Chimei Medical Center	National Cheng Kung University

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)		Baseline / Week 4/ Week 8/ Week12/ Week 16	No
Secondary	Score Change of relaxation-rating		Baseline / Week 4/ Week 8/ Week 12/ Week 16	No