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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

August 20, 2012
August 22, 2012
February 2010
December 2010   (final data collection date for primary outcome measure)
Score Change of The Panic Disorder Severity Scale(PDSS) [ Time Frame: Baseline / Week 4/ Week 8/ Week12/ Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01671033 on ClinicalTrials.gov Archive Site
Score Change of relaxation-rating [ Time Frame: Baseline / Week 4/ Week 8/ Week 12/ Week 16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Panic Disorder
  • 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.
  • 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.
    Intervention: Behavioral: Muscle Relaxation
  • 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.
    Interventions:
    • Behavioral: Biofeedback
    • Behavioral: Muscle Relaxation
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
January 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01671033
IRB 09902-006
Yes
Fong-Lin Jang, Chimei Medical Center
Chimei Medical Center
National Cheng Kung University
Study Director: Fong-Lin Jang, M.D. Chimei Medical Center
Chimei Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP