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Internet-based Cognitive Behavior Therapy After Myocardial Infarction (U-CARE: Heart)

2020年10月27日 更新者：Louise-von Essen、Uppsala University

A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction

The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).

研究概览

地位

完全的

条件

干预/治疗

详细说明

Major or minor depressive disorders and anxiety disorders are present in many patients with cardiovascular disease (CVD) and are associated with adverse cardiovascular outcomes, even after controlling for other risk factors. 500 patients with symptoms of anxiety and/or depression after MI will be randomized either to a 14 week Internet-based CBT-program or to treatment as usual (TAU) which is the control condition. A reference group of 250 participants without depressive or anxiety symptoms will also be studied during TAU. Data will be collected before, after and 7 months after treatment. Anxiety and depression according to ratings on the Hospital Anxiety and Depression Scale (HADS) are the primary outcome measures.

研究类型

介入性

注册 (实际的)

239

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

  • 瑞典
      • Enköping、瑞典
        • Enköpings lassarett
      • Falun、瑞典、79129
        • Falu Lasarett
      • Gävle、瑞典、80187
        • Gävle Sjukhus
      • Göteborg、瑞典
        • Sahlgrenska Sjukhuset
      • Hässleholm、瑞典
        • Hässleholms sjukhus
      • Karlskrona、瑞典
        • Blekinge sjukhus
      • Karlstad、瑞典
        • Karlstad sjukhus
      • Kungälv、瑞典
        • Kungälvs Sjukhus
      • Lidköping、瑞典
        • Skaraborgs Sjukhus
      • Ljungby、瑞典
        • Ljungby Lasarett
      • Malmö、瑞典
        • Skånes universitetssjukhus
      • Mora、瑞典
        • Mora lassarett
      • Nyköping、瑞典
        • Nyköpings sjukhus
      • Oskarshamn、瑞典
        • Oskarshamns sjukhus
      • Piteå、瑞典
        • Piteå älvdals sjukhus
      • Stockholm、瑞典
        • Danderyds Sjukhus
      • Stockholm、瑞典
        • Karolinska sjukhuset i Huddinge
      • Stockholm、瑞典
        • Karolinska sjukhuset i Solna
      • Stockholm、瑞典
        • Södersjukhuset
      • Sundsvall、瑞典
        • Länssjukhuset Sundsvall-Härnösand
      • Uppsala、瑞典、75185
        • Uppsala Akademiska Sjukhus
      • Varberg、瑞典
        • Varberg sjukhus
      • Växjö、瑞典
        • Växjö centrallasarett
      • Ängelholm、瑞典
        • Ängelholms sjukhus
      • Örebro、瑞典、70185
        • Universitetssjukhuset Orebro

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

不超过 75年 (孩子、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

Inclusion Criteria:

  • Patients younger than 75 years with a recent acute MI (< 3 months)
  • Depression and/or anxiety score of > 7 on one or both of the HADS subscales (concerns only the intervention, not the reference group)

Exclusion Criteria:

  • Patients that are scheduled for a coronary artery bypass surgery (CABG)
  • Unable or unwilling to use computer or Internet
  • Difficulties in reading or understanding Swedish
  • A life expectancy of less than a year
  • Anticipated poor compliance (multi-disease, substance abuse etc.)
  • Highly depressed or suicidal (MADRS-score > 29 or MADRS item 9 > 3)

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Internet-based CBT
Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.
行为的：Internet-based CBT

The participants read texts and do weekly homework assignments instructed from an Internet page. Additional resources like discussion forum, pictures, animations, videos and sounds will be a part of the treatment program.

A psychologist will communicate with the participants through internal text-messages. The therapist will devote about 10 minutes to each participant each week via the Internet. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment etc.
无干预：Treatment as usual (TAU)

Control: After randomization patients with symptoms of anxiety and/or depression after MI will participate in the treatment as usual (TAU).

Reference: A reference group without depressive or anxiety symptoms will participate in the treatment as usual (TAU).

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
Change in Depression (difference between the intervention and the control group)
大体时间：At baseline and 3 months later (after intervention)

Hospital Anxiety and Depression Scale (HADS) - depression ratings;

Montgomery Åsberg Depression Rating Scale (MADRS)
At baseline and 3 months later (after intervention)
Change in Anxiety (difference between the intervention and the control group)
大体时间：At baseline and 3 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
At baseline and 3 months later (after intervention)

次要结果测量

结果测量
措施说明
大体时间
Change in Quality of Life (difference between the intervention and the control group)
大体时间：At baseline, during, after (3 months after baseline) and 7 months after treatment
Ratings on EQ5d and Ladder of Life (LL)
At baseline, during, after (3 months after baseline) and 7 months after treatment
Change in Perceived Social Support (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
ENRICHED Social Support Inventory (ESSI)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Stress behaviors (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Everyday Life Stress Scale (ELSS)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Fatigue (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Maastricht Questionnaire (MQ)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Cardiac Anxiety (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Cardiac Anxiety Questionnaire (CAQ)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Sleeping Problems (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Insomnia Severity Index (ISI)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Posttraumatic Stress (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change in Posttraumatic Growth (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Quality of the Intervention
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Behavioral Activation for Depression Scale (BADS)-ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change to Follow-up in Anxiety (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
At baseline, after (3 months after baseline) and 7 months after treatment
Change to Follow-up in Depression (difference between the intervention and the control group)
大体时间：At baseline, after (3 months after baseline) and 7 months after treatment

Hospital Anxiety and Depression Scale (HADS) - depression ratings;

Montgomery Åsberg Depression Rating Scale (MADRS)
At baseline, after (3 months after baseline) and 7 months after treatment

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

Uppsala University

调查人员

  • 首席研究员：Louise von Essen, PhD、Uppsala University

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

有用的网址

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

2013年9月1日

初级完成 (实际的)

2017年12月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2011年12月19日

首先提交符合 QC 标准的

2012年1月4日

首次发布 (估计)

2012年1月5日

研究记录更新

最后更新发布 (实际的)

2020年10月29日

上次提交的符合 QC 标准的更新

2020年10月27日

最后验证

2020年10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

  • U-CARE: Heart

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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