Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158054
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2005-09-08
Brief Title:
COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Consortium for Translation of Psychosocial Depression Theories to Interventions and Dissemination - Project 2 Phase I Randomized Controlled Trial of Patient Preference Stepped-Care Treatment For Distress in Heart Disease Patients
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific aim of the Coronary Patients Evaluation Study COPES Project 2 is within a Phase-I RCT to examine patient satisfaction treatment safety and symptom reduction associated with treatment for symptoms of distress andor depressed mood among post acute coronary syndrome ACS patients as compared to usual cardiology care For the purposes of this study symptoms of distress andor depressed mood is defined by a score on the Beck Depression Inventory BDI 10 The specific treatment approach utilized follows the Improving Mood-Promoting Access to Collaborative Treatment IMPACT Clinical Trial and involves up to 6-months of a patient preference stepped-care protocol Within this protocol patients choose between brief problem focused psychotherapy and anti-depressant medication Treatment progress is reviewed at 2-month intervals providing opportunities to step-up treatment if patients are not demonstrating sufficient symptom reduction
Detailed Description:
Objectives To examine patient satisfaction treatment safety and symptom reduction associated with treatment for symptoms of distress andor depressed mood among post acute coronary syndrome ACS patients as compared to usual cardiology care
Research Design The Study utilizes a Phase-I RCT design to achieve this Aim
Methodology Patients with confirmed ACS are screened for symptoms of distress andor depressed mood within 7 days of the index ACS event using the Beck Depression Inventory BDI Those meeting inclusion criterion on the BDI score10 and consenting to study are followed for 3-months at which time they are re-assessed Those continuing to show BDI score 10 and consenting are randomized to the intervention condition INT or to usual cardiologic care UCC INT is defined by up to 6-months of a patient preference stepped care treatment whereby patients chose between brief problem-focused psychotherapy PST and antidepressant medication MED Patients are re-evaluated at 2- and 4-months after randomization Those not showing sufficient improvement in symptoms receive augmented therapy Those who initially choose PST can receive more frequent sessions andor the addition of MED those who initially choose MED can receive a change of agent an increase in dosage an additional medication andor PST
Hypotheses to be tested are
1 Patient satisfaction within intervention treatment INT will be higher than in the usual cardiologic care UCC condition as evidenced by self-report and levels of participation
2 The INT group will experience a greater reduction in symptoms of distress andor depression over the treatment period than the UCC group secondary hypothesis
3 Improvement in symptoms of distress andor depression will be associated with reduction in levels of inflammatory markers and improvement in adherence with physician prescribed aspirin therapy secondary hypothesis
This is a multi-site study involving Mt Sinai and Yale and Columbia University Schools of Medicine A total of 500 people will be screened into the initial observational period which occurs at the time of new ACS diagnosis From among these it is anticipated that 200 people will evidence persistent BDI 10 at 3-month follow-up and agree to be enrolled in the Phase 1 RCT
The clinical relevance of the Study concerns demonstration of the acceptability and satisfaction with the treatment approach by post-ACS patients as preliminary to a Phase-III RCT that would test the effect of such an intervention on event-free survival after ACS
Research Design The Study utilizes a Phase-I RCT design to achieve this Aim
Methodology Patients with confirmed ACS are screened for symptoms of distress andor depressed mood within 7 days of the index ACS event using the Beck Depression Inventory BDI Those meeting inclusion criterion on the BDI score10 and consenting to study are followed for 3-months at which time they are re-assessed Those continuing to show BDI score 10 and consenting are randomized to the intervention condition INT or to usual cardiologic care UCC INT is defined by up to 6-months of a patient preference stepped care treatment whereby patients chose between brief problem-focused psychotherapy PST and antidepressant medication MED Patients are re-evaluated at 2- and 4-months after randomization Those not showing sufficient improvement in symptoms receive augmented therapy Those who initially choose PST can receive more frequent sessions andor the addition of MED those who initially choose MED can receive a change of agent an increase in dosage an additional medication andor PST
Hypotheses to be tested are
1 Patient satisfaction within intervention treatment INT will be higher than in the usual cardiologic care UCC condition as evidenced by self-report and levels of participation
2 The INT group will experience a greater reduction in symptoms of distress andor depression over the treatment period than the UCC group secondary hypothesis
3 Improvement in symptoms of distress andor depression will be associated with reduction in levels of inflammatory markers and improvement in adherence with physician prescribed aspirin therapy secondary hypothesis
This is a multi-site study involving Mt Sinai and Yale and Columbia University Schools of Medicine A total of 500 people will be screened into the initial observational period which occurs at the time of new ACS diagnosis From among these it is anticipated that 200 people will evidence persistent BDI 10 at 3-month follow-up and agree to be enrolled in the Phase 1 RCT
The clinical relevance of the Study concerns demonstration of the acceptability and satisfaction with the treatment approach by post-ACS patients as preliminary to a Phase-III RCT that would test the effect of such an intervention on event-free survival after ACS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01HC25197-0-0-0 | NIH | Grant ID | httpsreporternihgovquickSearchN01HC25197-0-0-0 |
| GCO 02-0247 | OTHER | None | None |