Web-based Psychological Intervention to Coronary Artery Heart Disease Patients
Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Dec 2013
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 13, 2014
August 1, 2014
1 year
October 18, 2013
August 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Significantly reduce health care costs
intervention
Other Outcomes (1)
Psychosocial risk factor and characteristic cardiovascular responses present present in CAD patients on pre-group intervention
Pre- group intervention
Study Arms (2)
CAD-CBT group therapy
OTHERCAD receive web-based CBT group therapy
CAD-CBT group therapy waiting list
OTHERCAD waiting list will receive web-based CBT group therapy later
Interventions
Eligibility Criteria
You may qualify if:
- coronary artery disease
- regular medication
You may not qualify if:
- Psychiatric diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bee-Horng Lue
National Taiwna University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2013
First Posted
December 2, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 13, 2014
Record last verified: 2014-08