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

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

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.

Study Overview

• Status: Terminated
• Conditions: Panic Disorder
• Intervention / Treatment: Behavioral: Muscle Relaxation; Behavioral: Biofeedback

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 70246
    • ChiMei Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Muscle Relaxation; The patients of this arm practice on-line muscle relaxation every day.They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.	Behavioral: 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.
EXPERIMENTAL: Muscle Relaxation with Biofeedback; The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.	Behavioral: 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.; 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.; Other Names: finger temperature biofeedback
NO_INTERVENTION: Waiting-List; The patients of this arm waited for four weeks. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR (APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Impressions-Improvement(CGI) were performed by well-trained clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score Change of The Panic Disorder Severity Scale(PDSS)	Baseline / Week 4/ Week 8/ Week12/ Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Score Change of relaxation-rating	Baseline / Week 4/ Week 8/ Week 12/ Week 16

Collaborators and Investigators

• Sponsor: Chimei Medical Center
• Collaborators: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (ESTIMATE): August 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: cognitive behavior therapy; Panic disorder; Internet
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Anxiety Disorders; Disease; Panic Disorder
• Other Study ID Numbers: IRB 09902-006