Web-based Psychological Intervention to Coronary Artery Heart Disease Patients
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CBT
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
Eligibility Criteria
inclusion:
- coronary artery disease
- regular medication
exclusion:
1.Psychiatric diseases
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CAD-CBT group therapy
CAD-CBT group therapy waiting list
Arm Description
CAD receive web-based CBT group therapy
CAD waiting list will receive web-based CBT group therapy later
Outcomes
Primary Outcome Measures
Significant decrease of the psychological risk factors in web-based group CBT intervention group after an eight-week group intervention
Evaluate the effects to reduce the psychological risk factors and enhance the regulation of automatic nerve system:
Time point:Post-intervention, 3 months, and 6 months follow up
Subjective (self report inventories), including hostility, anxiety,and perceived stress.
Objective (Biofeedback devices):including blood vessel pulse, EKG, skin conductance, ect.
Secondary Outcome Measures
Significantly reduce health care costs
Evaluate indirect medical cost-effectiveness (travel time and money) during web-based Psychological Interventions
Full Information
NCT ID
NCT01998555
First Posted
October 18, 2013
Last Updated
August 11, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01998555
Brief Title
Web-based Psychological Intervention to Coronary Artery Heart Disease Patients
Official Title
Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate medical cost-effectiveness, reduce the psychological risk factors( including hostility, anxiety, depression, and perceived stress) in coronary artery disease (CAD) patients and enhance the regulation of the autonomic nervous system (including respiration rate, heart rate, distal blood vessel pulse, and finger temperament) through web-based cognitive -behavioral group therapy.
Detailed Description
Cognitive-behavioral therapy (CBT) is effective in reducing the level of anger, hostility and depression present in coronary artery disease (CAD) patients.In Taiwan, Weng et al. also confirmed the eight-week group CBT program not only diminished the emotion disturbances including anger, hostility and depression of CAD, but also significantly prolonged the coagulation time, thus reducing the rate of thrombosis formation. Even though the therapeutic effect of the CBT program was valid, this program is still not accessible for some patients in need because they are not aware of it, or they are restricted by time and transportation. Internet-based therapeutic intervention can overcome the obstacles to access this program at any time and in any place. Presently, structured CBT intervention is provided through the Internet and used widely by patients with physical or psychological problems such as smoking, obesity, or headaches, but not by CAD patients. Therefore, the purpose of this research is to evaluate the effects to reduce the psychological risk factors of a web-based group CBT program in CAD patients. Follow-up assessments will be performed after 3 and 6-month durations. The investigators expect that, after an eight-week group intervention, there will be significant decrease of the psychological risk factors. Moreover, the therapeutic effects can be maintained during the three- and six-month follow-up.evaluate In addition, web-based cognitive -behavioral group therapy will significantly reduce indirect medical costs (travel time and money).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAD-CBT group therapy
Arm Type
Other
Arm Description
CAD receive web-based CBT group therapy
Arm Title
CAD-CBT group therapy waiting list
Arm Type
Other
Arm Description
CAD waiting list will receive web-based CBT group therapy later
Intervention Type
Other
Intervention Name(s)
CBT
Primary Outcome Measure Information:
Title
Significant decrease of the psychological risk factors in web-based group CBT intervention group after an eight-week group intervention
Description
Evaluate the effects to reduce the psychological risk factors and enhance the regulation of automatic nerve system:
Time point:Post-intervention, 3 months, and 6 months follow up
Subjective (self report inventories), including hostility, anxiety,and perceived stress.
Objective (Biofeedback devices):including blood vessel pulse, EKG, skin conductance, ect.
Time Frame
Time point(s) at post-group intervention, 3 months, and 6 months follow up
Secondary Outcome Measure Information:
Title
Significantly reduce health care costs
Description
Evaluate indirect medical cost-effectiveness (travel time and money) during web-based Psychological Interventions
Time Frame
intervention
Other Pre-specified Outcome Measures:
Title
Psychosocial risk factor and characteristic cardiovascular responses present present in CAD patients on pre-group intervention
Description
Time point:Pre-group intervention
Subjective (self report inventories), including hostility, anxiety,and perceived stress.
Objective (Biofeedback devices):including blood vessel pulse, EKG, skin conductance, ect.
Time Frame
Pre- group intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion:
coronary artery disease
regular medication
exclusion:
1.Psychiatric diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bee-Horng Lue
Organizational Affiliation
National Taiwna University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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Web-based Psychological Intervention to Coronary Artery Heart Disease Patients
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