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

This study has been terminated.
(The drop-out rate was too high.)
Sponsor:
Collaborator:
National Cheng Kung University
Information provided by (Responsible Party):
Fong-Lin Jang, Chimei Medical Center
ClinicalTrials.gov Identifier:
NCT01671033
First received: August 20, 2012
Last updated: August 22, 2012
Last verified: April 2010
  Purpose

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.


Condition Intervention
Panic Disorder
Behavioral: Biofeedback
Behavioral: Muscle Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Muscle Relaxation With Biofeedback Via Internet for Panic disorder-a Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Chimei Medical Center:

Primary Outcome Measures:
  • Score Change of The Panic Disorder Severity Scale(PDSS) [ Time Frame: Baseline / Week 4/ Week 8/ Week12/ Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score Change of relaxation-rating [ Time Frame: Baseline / Week 4/ Week 8/ Week 12/ Week 16 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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 Name: finger temperature biofeedback
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.
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671033

Locations
Taiwan
Chimei Medical Center
Tainan, Taiwan, 70246
Sponsors and Collaborators
Chimei Medical Center
National Cheng Kung University
Investigators
Study Director: Fong-Lin Jang, M.D. Chimei Medical Center
  More Information

No publications provided

Responsible Party: Fong-Lin Jang, M.D., Chimei Medical Center
ClinicalTrials.gov Identifier: NCT01671033     History of Changes
Other Study ID Numbers: IRB 09902-006
Study First Received: August 20, 2012
Last Updated: August 22, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chimei Medical Center:
Panic disorder
cognitive behavior therapy
Internet

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014