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Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers

2018年8月15日 更新者：Ana-Maria Vranceanu, PhD、Massachusetts General Hospital

Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers

The current study has the following objectives:

  1. To determine additional stroke patient (SP) and stroke caregiver (SC) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess SP and SC preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention.
  2. To develop, [using the preliminary data and information from aim 1], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:

  • Age 18 or older
  • English fluency and literacy
  • Hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) OR primary stroke caregiver of a stroke patient currently admitted with an acute stroke
  • Stroke patient or stroke caregiver screens in for depression and/or PTSD

One or more of the following exclusion criteria will render a stroke patient (only) ineligible:

  • Stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Psychosocial Skills-Based Intervention
Based on information from Phase I (semi-structured interviews), the investigators will develop a detailed psychosocial intervention manual. The intervention will be tailored consistent with American Heart Association (AHA) recommendations for stroke skills based interventions and will include 2 general and 4 specific modules (selected from 7 available). Generally, in the intervention, stroke patients and stroke caregivers will learn skills to cope and manage stroke-related stressors. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered within the NICU face to face and 4 tailored specific sessions to be delivered via live video using Vidyo. Participants in the intervention group will also receive treatment as usual.
行为的：Psychosocial Skills-Based Intervention
Subjects will attend group skills-based sessions once weekly (either in-person or via Vidyo) for 6 weeks and learn skills to cope and manage stroke-related stressors.
无干预：Minimally Enhanced Usual Care (MEUC)
Those in the MEUC will continue with their current care. This may include meeting with nurses, physical therapist, medical doctors, and other members of the stroke patient's medical team. Treatment as usual may also involve administration of Selective Serotonin Reuptake Inhibitors (SSRIs) to those patients with motor problems. They will also received a pamphlet with educational information on stroke and recovery

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of the Intervention
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Demonstration of feasibility will be assessed by the number of individuals who drop out of the study prior to completing the post- intervention assessment and the rate of missed sessions. If drop-out rate or missed-session rate exceeds 25%, revisions to the intervention may be needed.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Client Satisfaction Questionnaire (CSQ-8)
大体时间：Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures how satisfied the participant is with the intervention.
Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

次要结果测量

结果测量
措施说明
大体时间
Measure of Current Status (MOCS-A)
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Cognitive and Affective Mindfulness Scale (CAMS)
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures the degree to which individuals experience their thoughts and feelings.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
World Health Organization QOL Questionnaire (WHOQOL-BREF)
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Modified Rankin Scale (mRS)
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures the patient's prior stroke status and stroke severity.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Hospital Anxiety and Depression Scale (HADS)
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures symptoms of anxiety and depression.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Posttraumatic Stress (PCL-S)
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures symptoms of posttraumatic stress disorder
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Current psychotropic meds and comorbid medical conditions,
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Barthel Index
大体时间：Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measures the patient's prior stroke status and stroke severity.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

其他结果措施

结果测量
措施说明
大体时间
ICU 患者/护理人员的年龄、性别、种族、民族、婚姻状况、教育状况和就业状况
大体时间：基线（第 0 周）
该问卷要求 ICU 患者/护理人员报告他们在过去 12 个月内的年龄、性别、种族、民族、婚姻状况、最高教育水平和主要就业状况。
基线（第 0 周）
信誉问卷
大体时间：基线（第 0 周）
衡量参与者认为干预有效的程度。
基线（第 0 周）
Prior Mental Health Questionnaire
大体时间：Baseline (week 0)
This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.
Baseline (week 0)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

合作者

American Heart Association

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年7月1日

初级完成 (实际的)

2018年6月1日

研究完成 (实际的)

2018年8月1日

研究注册日期

首次提交

2016年6月2日

首先提交符合 QC 标准的

2016年6月7日

首次发布 (估计)

2016年6月13日

研究记录更新

最后更新发布 (实际的)

2018年8月17日

上次提交的符合 QC 标准的更新

2018年8月15日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2016P001190

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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