Coronary Artery DiseaseNCT01998555
Web-based Psychological Intervention to Coronary Artery Heart Disease Patients
A study testing CBT in people with Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease
- regular medication
Who cannot join
- 1.Psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients
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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- CBT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTOther
| Study group | Role | What they receive |
|---|---|---|
| CAD-CBT group therapy | Other | CAD receive web-based CBT group therapy Receives: Other: CBT |
| CAD-CBT group therapy waiting list | Other | CAD waiting list will receive web-based CBT group therapy later Receives: Other: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time point(s) at post-group intervention, 3 months, and 6 months follow up
Secondary outcomes (1)
Significantly reduce health care costs
Evaluate indirect medical cost-effectiveness (travel time and money) during web-based Psychological Interventions
Measured: intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bee-Horng Lue, Principal investigator, National Taiwna University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998555
- Sponsor's protocol ID
- 201306066RINC
- Status last verified
- Aug 2014
- First submitted
- 18 Oct 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients
- ClinicalTrials.gov ID
- NCT01998555
- Acronym / sponsor ID
- 201306066RINC
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD-CBT group therapy | Other | Other: CBTCAD receive web-based CBT group therapy |
| CAD-CBT group therapy waiting list | Other | Other: CBTCAD waiting list will receive web-based CBT group therapy later |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- coronary artery disease
- regular medication
Key exclusion criteria (1 listed)
- 1.Psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT | Other | CAD-CBT group therapy, CAD-CBT group therapy waiting list |
Primary outcome
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
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.
1 secondary outcome
Significantly reduce health care costs
Time frame: intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bee-Horng Lue principal investigator
National Taiwna University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.