Internet-based Cognitive Behavioural Therapy for Cardiac Patients
2019年10月1日 更新者：Martha Mackay、University of British Columbia
A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy for Cardiac Patients With Depression
Our overall objective is to evaluate the efficacy of therapist-assisted, internet-based cognitive-behavioural therapy (iCBT) for depressed cardiac patients with respect to clinical outcomes, and the feasibility of the program.
Our primary outcome will be depression severity; secondary outcomes will be hospitalization for a cardiac cause, recurrent myocardial infarction or revascularization.
The study will inform a proposal to incorporate iCBT into the resources routinely available to cardiac patients following hospitalization for a cardiac event.
研究概览
详细说明
We are planning we are planning a single-arm, open label trial to evaluate the feasibility, acceptability and efficacy of iCBT among persistently depressed cardiac patients.
Cardiac patients will be recruited from inpatient units in a university-affiliated hospital and screened for depression at 4 and possibly 8 or 12 weeks following discharge.
Eligible patients will be enrolled in the iCBT program.Data regarding the primary outcome, improvement in depression severity, will be collected at completion of the intervention and at 8 weeks after completion.
In addition to depression severity data, we will also obtain other data related to clinical feasibility, such as treatment adherence and the acceptability of the intervention to patients.
Self-reported rates of hospital readmission or emergency visits for a cardiac cause will also be tracked.
研究类型
介入性
注册 (预期的)
80
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
-
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z1Y6
- 招聘中
- St. Paul's Hospital, Providence Health Care
-
接触：
- Martha Mackay, PhD
- 电话号码：63127 6046822344
- 邮箱：mmackay@providencehealth.bc.ca
-
-
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
19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
Inclusion Criteria:
- admitted to one of study units with any cardiac diagnosis OR cardiac procedure on this admission
- able to speak and read English
- able to provide informed consent and participate in therapy
- access to and ability to use a computer with internet access.
Between 4 and 12 weeks after discharge, consenting participants will be required to meet a further inclusion criterion of:
• current depressive symptoms of at least mild severity on 2 successive assessments, 4 weeks apart or a single assessment of mild symptoms at 12 weeks post-discharge.
Exclusion Criteria:
Applied at screening (and criteria 1 and 2 reapplied before enrolment):
- active suicidal ideation (since this requires immediate referral for intense psychiatric care)
- previous suicide attempt
- currently undergoing psychotherapy for depression
- receiving antidepressant medication that has been initiated or adjusted within previous 3 months
- concurrent psychiatric disorder, other than anxiety;
- self-reported substance misuse within past 6 months
- concurrent terminal illness
- clinical status interfering with ability to independently engage in iCBT.
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：不适用
- 介入模型：单组作业
- 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：treatment
all participants will be assigned to the treatment, consisting of therapist-assisted iCBT.
|
Designed for general clinical use (but not specifically cardiac patients), it consists of 5 online modules outlining cognitive-behavioural skills for depression, completed over 7-8 weeks.
The participants will be guided step-wise through the modules by the therapist.
Participants can work more or less at their own pace, but are expected to proceed to the next module within 1-2 weeks.
Because the content is identical for each participant, fidelity to the web-based component of the intervention is ensured.
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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 |
|---|---|---|
|
Depression Severity
大体时间：baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)
|
change in severity of depression as measured by Patient Health Questionnaire-9
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baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
major adverse cardiac events
大体时间：completion of treatment, average of 8 weeks
|
death, myocardial infarction, revascularization, hospitalization for a cardiac cause
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completion of treatment, average of 8 weeks
|
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Treatment Satisfaction Questionnaire
大体时间：completion of treatment, average of 8 weeks
|
participants' satisfaction with treatment
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completion of treatment, average of 8 weeks
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Web-Based Program Usability Questionnaire
大体时间：completion of treatment, average of 8 weeks
|
participants' experience with using the web-based program
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completion of treatment, average of 8 weeks
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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。
调查人员
- 首席研究员：Martha H Mackay, PhD、University of British Columbia
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)
2019年8月26日
初级完成 (预期的)
2020年6月1日
研究完成 (预期的)
2020年12月1日
研究注册日期
首次提交
2019年8月7日
首先提交符合 QC 标准的
2019年8月9日
首次发布 (实际的)
2019年8月12日
研究记录更新
最后更新发布 (实际的)
2019年10月3日
上次提交的符合 QC 标准的更新
2019年10月1日
最后验证
2019年10月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
We would share all of our de-identified, individual-level data with any credentialed researcher.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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
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.