COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
|ClinicalTrials.gov Identifier: NCT00158054|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : March 3, 2016
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Depression||Behavioral: Enhanced depression care Behavioral: Referred depression care||Not Applicable|
Objectives: To examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or 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 and/or depressed mood within 7 days of the index ACS event, using the Beck Depression Inventory (BDI). Those meeting inclusion criterion on the BDI (score>10) 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 and/or the addition of MED; those who initially choose MED can receive a change of agent, an increase in dosage, an additional medication, and/or PST.
Hypotheses to be tested are:
- 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
- The INT group will experience a greater reduction in symptoms of distress and/or depression over the treatment period than the UCC group (secondary hypothesis).
- Improvement in symptoms of distress and/or 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||April 2015|
Experimental: Intervention Condition (INT)
Enhanced depression care: Participants assigned to INT condition will be given an information brochure describing the intervention. This description will include an overview of the two elements of treatment (Problem Solving Therapy (PST), pharmacotherapy), the choice that the participant has for which element of treatment they will receive, and the stepped care aspect of treatment.
Behavioral: Enhanced depression care
Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.
Usual Cardiologic Care Condition (UCC)
Referred depression care: Participants assigned to the usual cardiologic care condition (UCC) condition will be scheduled for their next follow-up visit and thanked for their time.
Behavioral: Referred depression care
Physician notified of depression symptoms, usual care followed.
Other Name: Usual Cardiologic Care (UCC)
- Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. [ Time Frame: 6 months ]Number of participants who rated their depression care as excellent or very good as a percentage.
- Level of Depressive Symptoms [ Time Frame: 6 months ]Depressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).
- Number of Participants Experiencing Major Adverse Cardiovascular Events [ Time Frame: 6 months ]The table represents the number of participants experiencing major adverse cardiovascular events
- All-cause Mortality [ Time Frame: 18 months ]All- cause mortality
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158054
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|New York, New York, United States, 10032|
|Principal Investigator:||Karina Davidson, Ph.D.||Columbia University|