Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
Primary Purpose
Panic Disorder
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
relaxation
biofeedback (finger temperature biofeedback)
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring Panic Disorder, Temperature Biofeedback, Internet
Eligibility Criteria
Inclusion Criteria:
- The participant must fulfill DSM-IV criteria for panic disorder.
- The participant must be between 18 and 60 years of age.
- The participant must have panic disorder as the primary problem.
- 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.
- If the participant was already in therapy, the contact must have lasted at least 6 months and not be based on cognitive behavior therapy.
- All participants have access to a computer with an Internet connection.
Exclusion Criteria:
- The participant suffers from any other psychiatric disorder in immediate need of treatment.
- The participant fulfills DSM-IV criteria for major depression.
- The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. The participant has alcoholism.
Sites / Locations
- Psychiatry Department, Chimei Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
relaxation
relaxation & biofeedback
Arm Description
The patients of this arm practice on-line muscle relaxation for 8 weeks.
The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks.
Outcomes
Primary Outcome Measures
score change of The Panic Disorder Severity Scale(PDSS)
Secondary Outcome Measures
score change of MOS 36-Item Short-Form Health Survey (SF-36)
Full Information
NCT ID
NCT00825136
First Posted
January 15, 2009
Last Updated
August 19, 2012
Sponsor
Chimei Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00825136
Brief Title
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
Official Title
A Study on Mental Health Care by Using Specific Vital Signs
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
The main limitations were the small sample size and low completion rate.
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chimei Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic Disorder, Temperature Biofeedback, Internet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
relaxation
Arm Type
Active Comparator
Arm Description
The patients of this arm practice on-line muscle relaxation for 8 weeks.
Arm Title
relaxation & biofeedback
Arm Type
Experimental
Arm Description
The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
relaxation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
biofeedback (finger temperature biofeedback)
Intervention Description
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.
Primary Outcome Measure Information:
Title
score change of The Panic Disorder Severity Scale(PDSS)
Time Frame
day 1 / 4 weeks/ 8 weeks
Secondary Outcome Measure Information:
Title
score change of MOS 36-Item Short-Form Health Survey (SF-36)
Time Frame
day 1 / 4 weeks/ 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant must fulfill DSM-IV criteria for panic disorder.
The participant must be between 18 and 60 years of age.
The participant must have panic disorder as the primary problem.
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.
If the participant was already in therapy, the contact must have lasted at least 6 months and not be based on cognitive behavior therapy.
All participants have access to a computer with an Internet connection.
Exclusion Criteria:
The participant suffers from any other psychiatric disorder in immediate need of treatment.
The participant fulfills DSM-IV criteria for major depression.
The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. The participant has alcoholism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fong-Lin Jang, M.D.
Organizational Affiliation
Chimei Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Psychiatry Department, Chimei Medical Center
City
Tainan
ZIP/Postal Code
700
Country
Taiwan
12. IPD Sharing Statement
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Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
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