Evaluation of Two Psychotherapies for Depressed Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Hamilton Depression Rating Scale (HAM-A)
研究概览
简要总结
The primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson's Disease.
详细描述
The primary aim of this study is to determine whether IPT is more efficacious than an intervention that controls for non-specific factors (i.e., supportive psychotherapy) in reducing depressive symptoms. A secondary aim is to determine whether IPT is better than supportive therapy in improving quality of life, interpersonal functioning, attachment patters, and motor symptoms, and whether treatment gains are durable at 6-months follow-up. An exploratory aim of the study is identify moderators and mediators of treatment outcome. Patients who meet study criteria will be randomly assigned to either 12 sessions of IPT or 12 sessions of supportive therapy. The primary efficacy measure (Hamilton Depression Rating Scale) will be administered at baseline, weeks 6 and 12, and at 6 months follow-up.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with idiopathic Parkinson's disease and between stages 1 and 3 in the modified Hohn & Yahr Clinical Staging Scale
- •Diagnosis of a depressive disorder
- •Score ≥ 12 on the 17-item Hamilton Depression Rating Scale
- •Living independently
排除标准
- •History of bipolar disorder or psychotic symptoms (other than drug induced)
- •Substance-related disorders in the last 12 months
- •Acutely suicidal or history of suicide attempts in the past 5 years
- •Presence of cognitive deficits (i.e., score ≤ 24 on the Mini Mental Status Exam) or history of significant cognitive disorders
- •Presence of other significant neurological problems
- •Presence of unstable comorbid medical conditions
- •Currently receiving psychotherapy
- •Unable to attend weekly therapy sessions
结局指标
主要结局
Hamilton Depression Rating Scale (HAM-A)
时间窗: Change from baseline to week 12 and 6-months follow-up
17-item clinician rated scale that assesses severity of depressive symptoms
次要结局
- Experiences in Close Relationship Scale-Revised (ECR-R)(Change from baseline to week 12 and 6-months follow-up)
- Parkinson's Disease Questionnaire (PDQ-39)(Change from baseline to week 12 and 6-months follow-up)
- Interpersonal Relationships Inventory (IPRI)(Change from baseline to week 12 and 6-months follow-up)
- Beck Depression Inventory (BDI)(Change from baseline to week 12 and 6-months follow-up)
- Beck Anxiety Inventory (BAI)(Change from baseline to week 12 and 6-months follow-up)
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Change from baseline to week 12 and 6-months follow-up)