Web-based Psychological Intervention to Coronary Artery Heart Disease Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01998555
First received: October 18, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Significant decrease of the psychological risk factors in web-based group CBT intervention group after an eight-week group intervention [ Time Frame: Time point(s) at post-group intervention, 3 months, and 6 months follow up ] [ Designated as safety issue: No ]

    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 [ Time Frame: intervention ] [ Designated as safety issue: No ]
    Evaluate indirect medical cost-effectiveness (travel time and money) during web-based Psychological Interventions


Other Outcome Measures:
  • Psychosocial risk factor and characteristic cardiovascular responses present present in CAD patients on pre-group intervention [ Time Frame: Pre- group intervention ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CAD-CBT group therapy
CAD receive web-based CBT group therapy
Other: CBT
CAD-CBT group therapy waiting list
CAD waiting list will receive web-based CBT group therapy later
Other: CBT

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).

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

inclusion:

  1. coronary artery disease
  2. regular medication

exclusion:

1.Psychiatric diseases

  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: NCT01998555

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Bee-Horng Lue National Taiwna University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01998555     History of Changes
Other Study ID Numbers: 201306066RINC
Study First Received: October 18, 2013
Last Updated: August 11, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014