Randomized Trial of Depression Follow-up Care by Email
2015年6月3日 更新者：PD Dr. phil. Birgit Watzke、Universitätsklinikum Hamburg-Eppendorf
Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression
The primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.
研究概览
详细说明
Depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease.
Although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase.
Therefore options of follow-up care have to be considered.
Since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.
研究类型
介入性
注册 (实际的)
92
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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Hamburg、德国、20246
- University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
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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
Inclusion Criteria:
- Depressive disorder: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10
- Precursory CBT
- Internet access
Exclusion Criteria:
- No knowledge of the German language
- Risk of suicide
- Acute psychosis or psychotic symptoms
- Established concurrent in vivo CBT after discharge from inpatient CBT
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 |
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实验性的：E-mail follow up care
After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week).
The follow up care aims at supporting the patients in continuing exercises they have learned during the initial treatment phase in order to cope with depression, e.g.
integrating positive activities in their all day life or monitoring the interdependence of cognition, emotion and behaviour.
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After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week).
The follow up care aims at supporting the patients in continuing exercises in order to cope with depression.
其他名称：
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无干预：Treatment as usual
After having terminated inpatient CBT patients receive treatment as usual within routine care.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Measure of the severity of depression - Beck Depression Inventory (BDI- II)
大体时间：Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measure of health related quality of life - SF-8
大体时间：Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
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SF-8: short version of the SF -36
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Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
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GAD-7
大体时间：Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Measure for generalized anxiety disorder
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Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Depressive relapse/recurrence
大体时间：Measured at follow up (3 months after termination of the follow-up care)
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Measured at follow up (3 months after termination of the follow-up care)
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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：Birgit Watzke, PhD、University Medical Center Hamburg-Eppendorf Centre of Psychosocial Medicine Department of Medical Psychology
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
2012年9月1日
初级完成 (实际的)
2013年9月1日
研究完成 (实际的)
2013年11月1日
研究注册日期
首次提交
2011年10月6日
首先提交符合 QC 标准的
2011年10月7日
首次发布 (估计)
2011年10月10日
研究记录更新
最后更新发布 (估计)
2015年6月4日
上次提交的符合 QC 标准的更新
2015年6月3日
最后验证
2015年6月1日
更多信息
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.