Coronary Artery DiseaseNCT00522717
Enhancing Recovery After Cardiac Surgery
A study testing Cognitive Behavioral Therapy (CBT) in people with Coronary Artery Disease and Depression, run by University of California, Los Angeles at 5 sites in United States.
Trial summary
Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of depression, and depression is associated with higher risk of complications and death. Recent discoveries show that depression involves changes in certain molecules in the blood, which are also involved in progressive coronary… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Coronary Artery Disease, Depression
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2005to May 2010
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone CABG at one of our recruitment sites
Who cannot join
- Less than 45 years of age
- Have cognitive impairment or major comorbid psychiatric conditions
- Have autoimmune disorder or malignancy
- Currently smoking
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Long Beach Memorial Medical Center
Long Beach, California, 90806
Cedars-Sinai Medical Center
Los Angeles, California, 90027
Kaiser Permanente Medical Center - Sunset
Los Angeles, California, 90027
Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles
Los Angeles, California, 90073
University of California, Los Angeles School of Nursing
Los Angeles, California, 90095
About this study
Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of depression, and depression is associated with higher risk of complications and death. Recent discoveries show that depression involves changes in certain molecules in the blood, which are also involved in progressive coronary artery disease (CAD) and its complications. This study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for depression on these biological markers among CABG patients.
- Conditions
- Coronary Artery Disease, Depression
- Being tested
- Cognitive Behavioral Therapy (CBT), Usual Care
- Medical subject headings
- Coronary Artery Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
Usual CareBehavioural
Subjects receive Usual Care for 8 weeks followed by CBT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| 2 | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of proinflammatory cytokines (IL-1 and IL-6)
Measured: at baseline and after 8 weeks (at the completion of the intervention)
The soluble receptor for IL-6 (sIL-6)
Measured: at baseline and after 8 weeks (at the completion of the intervention)
Inflammatory markers c-reactive protein (CRP and sICAM-1)
Measured: at baseline and after 8 weeks (at the completion of the intervention)
Secondary outcomes (4)
Depression symptoms (Beck Depression Inventory)
Measured: at baseline and after 8 weeks (at the completion of the intervention)
Presence of clinical depression
Measured: at baseline and after 8 weeks (at the completion of the intervention)
Pain
Measured: at baseline and after 8 weeks (at the completion of the intervention)
Sleep disturbances
Measured: at baseline and after 8 weeks (at the completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startJul 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Belinda Chen, University of California, Los Angeles
- Investigators
- Lynn Doering, RN, DNSc, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522717
- Sponsor's protocol ID
- 5R01NR009228-02
- Other IDs
- R01NR009228
- Status last verified
- Nov 2015
- First submitted
- 29 Aug 2007
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doering LV, Chen B, McGuire A, Bodan RC, Irwin MR. Persistent depressive symptoms and pain after cardiac surgery. Psychosom Med. 2014 Jul-Aug;76(6):437-44. doi: 10.1097/PSY.0000000000000074.
PubMed 24979578Hwang B, Eastwood JA, McGuire A, Chen B, Cross-Bodan R, Doering LV. Cognitive behavioral therapy in depressed cardiac surgery patients: role of ejection fraction. J Cardiovasc Nurs. 2015 Jul-Aug;30(4):319-24. doi: 10.1097/JCN.0000000000000155.
PubMed 24763358
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00522717
- Acronym / sponsor ID
- 5R01NR009228-02
- Conditions
- Coronary Artery Disease, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Aug 2007 (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.
Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of depression, and depression is associated with higher risk of complications and death. Recent discoveries show that depression involves changes in certain molecules in the blood, which are also involved in progressive coronary artery disease (CAD) and its complications. This study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for depression on these biological markers among CABG patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT) |
| 2 | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergone CABG at one of our recruitment sites
Key exclusion criteria (4 listed)
- Less than 45 years of age
- Have cognitive impairment or major comorbid psychiatric conditions
- Have autoimmune disorder or malignancy
- Currently smoking
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy. | Behavioural | 1 |
| Usual CareSubjects receive Usual Care for 8 weeks followed by CBT | Behavioural | 2 |
Primary outcome
Levels of proinflammatory cytokines (IL-1 and IL-6)
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
The soluble receptor for IL-6 (sIL-6)
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
Inflammatory markers c-reactive protein (CRP and sICAM-1)
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
4 secondary outcomes
Depression symptoms (Beck Depression Inventory)
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
Presence of clinical depression
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
Pain
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
Sleep disturbances
Time frame: at baseline and after 8 weeks (at the completion of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 24979578Doering LV, Chen B, McGuire A, Bodan RC, Irwin MR. Persistent depressive symptoms and pain after cardiac surgery. Psychosom Med. 2014 Jul-Aug;76(6):437-44. doi: 10.1097/PSY.0000000000000074.
- Derived from this study: PubMed 24763358Hwang B, Eastwood JA, McGuire A, Chen B, Cross-Bodan R, Doering LV. Cognitive behavioral therapy in depressed cardiac surgery patients: role of ejection fraction. J Cardiovasc Nurs. 2015 Jul-Aug;30(4):319-24. doi: 10.1097/JCN.0000000000000155.
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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.
Lynn Doering, RN, DNSc principal investigator
University of California, Los Angeles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with Coronary Artery Disease and Depression, run by University of California, Los Angeles at 5 sites in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Levels of proinflammatory cytokines (IL-1 and IL-6) (time frame: at baseline and after 8 weeks (at the completion of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522717, which also lists 2 linked publications.
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 2 Dec 2015.