Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up
研究概览
简要总结
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.
详细描述
Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.
Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.
Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HF New York Heart Association classes: II-IV.
- •Life expectancy of more than 6 months.
- •PHQ-9 score ≥
- •Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.
排除标准
- •Imminent danger to self or others.
- •Cognitive impairments with a MOCA score of <
- •Bipolar, Psychotic, and Substance-induced Disorders.
- •Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
研究组 & 干预措施
Patients: Medication Management (MEDS)
The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.
干预措施: Medication Management (Drug)
Patients: Behavioral Activation Therapy (BA)
BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.
干预措施: Behavioral Activation Therapy (Behavioral)
结局指标
主要结局
Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up
时间窗: 6 months from baseline enrollment.
PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression)
次要结局
- Mortality Was Also Measured(3 month, 6 month, and 12 months from baseline enrollment)
- Mean Number of Emergency Department Visits(3 month, 6 month, and 12 months from baseline enrollment)
- Mean Number of Readmissions (Hospitalization)(3 month, 6 month, and 12 months from baseline enrollment)
- Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results(3 month, 6 month, and 12 months from baseline enrollment)
- Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results.(3 month, 6 month, and 12 months from baseline enrollment)
- Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results.(3 month, 6 month, and 12 months from baseline enrollment)
- If Hospitalized, Mean Number of Total Days in the Hospital(3 month, 6 month, and 12 months from baseline enrollment)
研究者
Waguih William IsHak, MD, FAPA
Vice Chair, Education and Research in the Department of Psychiatry and Behavioral Neurosciences, Professor Psychiatry & Behavioral Neurosciences
Cedars-Sinai Medical Center