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临床试验/NCT01133106
NCT01133106已完成不适用

Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)

University of Washington2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Hamilton Rating Scale for Depression (HRSD)

研究概览

简要总结

The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT) in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care (arm C), in terms of percent reduction in depressive symptoms and % of participants achieving remission of symptoms.

详细描述

This is the second phase of a study whose aim was to evaluate the short and long-term efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant)for the treatment of post-stroke depression (PSD) in survivors of ischemic stroke (registered as clinical trail NCT00194454). In the earlier trial we demonstrated that a pleasant event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse practitioners was highly effective in treating major depression and promoting remission in ischemic stroke survivors for up to two years. In this phase, we refine the protocol, and potentially make it more cost effective, by conducting a randomized comparative effectiveness trial of in-person versus telephone delivery of the intervention, comparing with usual care control. We also seek to expand our sample to include hemorrhagic stroke survivors (intraparenchymal hemorrhage and subarachnoid hemorrhage) as well as those with ischemic stroke.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hospitalized for an ischemic or hemorrhagic stroke (intraparenchymal hemorrhage- IPH or subarachnoid hemorrhage - SAH) in the past 3 months
  • clinical depression symptoms (Geriatric Depression Score -GDS >= 11

排除标准

  • major psychiatric co-morbidity
  • active suicidal ideation without ability to contract for safety
  • current substance abuse
  • physical inability to tolerate 1-2 hour sessions
  • receptive or global aphasia
  • reduced level of consciousness (GCS<15).

结局指标

主要结局

Hamilton Rating Scale for Depression (HRSD)

时间窗: 1 year post-treatment

Remission is defined as an HRSD score of 9 or less on the 17 item scale

次要结局

  • Stroke Impact Scale (SIS)(1 year post treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pamela Mitchell

Professor, School of Nursing

University of Washington

研究点 (2)

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