Web-based Psychological Intervention to Coronary Artery Heart Disease Patients

Coronary Artery Disease Clinical Trial

Official title:

Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01998555
• Other study ID #: 201306066RINC
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 2013
• Last updated: August 11, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

inclusion:

1. coronary artery disease

2. regular medication

exclusion:

1.Psychiatric diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• CBT

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychosocial risk factor and characteristic cardiovascular responses present present in CAD patients on pre-group intervention	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.	Pre- group intervention	No
Primary	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.	Time point(s) at post-group intervention, 3 months, and 6 months follow up	No
Secondary	Significantly reduce health care costs	Evaluate indirect medical cost-effectiveness (travel time and money) during web-based Psychological Interventions	intervention	No