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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 4
- 主要终点
- Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.
研究概览
简要总结
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 and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or 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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization with a verified diagnosis of unstable angina (UA) or acute myocardial infarction (AMI). UA is defined as new-onset angina within 2 months, exacerbation of previous angina with pain at rest or with minimal exercise, prolonged chest pain (lasting > 20 minutes), or angina within 2 weeks following discharge for myocardial infarction in patients with documented coronary artery disease (defined as ischemic ECG ST-T segment changes, previously documented MI, positive nuclear treadmill test result, or coronary angiographic evidence of blockage of 50% stenosis in >1 major coronary artery). AMI is defined as at least 2 of the following: ischemic chest pain lasting >20 minutes, acute rise in serum troponin-I >1.0 ng/L, and new pathologic ST segments in >2 contiguous ECG leads.
- •Score on the Beck Depression Inventory (BDI) > 10 within 7 days of index ACS event and 3-months later.
排除标准
- •active suicidal or homicidal ideation, as these patients require immediate referral for assessment and treatment (see below for procedures for these patients);
- •current alcohol or other substance abuse disorders (as depressive symptoms may be a result of these disorders),
- •any current psychotic disorder,
- •history of psychotic disorder, bipolar disorder, or serious personality disorders,
- •diagnosis of a terminal non-cardiac illness,
- •ACS diagnosis secondary to diagnosis of a severe medical disease,
- •inability to communicate in English,
- •levels of cognitive impairment indicative of dementia,
- •unavailability for the period of the study,
- •overt hypothyroid, and
- •currently taking triptans.
研究组 & 干预措施
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.
干预措施: Enhanced depression care (Behavioral)
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.
干预措施: Referred depression care (Behavioral)
结局指标
主要结局
Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.
时间窗: 6 months
Number of participants who rated their depression care as excellent or very good as a percentage.
次要结局
- Level of Depressive Symptoms(6 months)
- Number of Participants Experiencing Major Adverse Cardiovascular Events(6 months)
- All-cause Mortality(18 months)
研究者
Karina Davidson
Professor of Behavioral Medicine
Columbia University