Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems (TAYLOR1)
2010年12月27日 更新者:Linkoeping University
Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems
The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.
研究概览
地位
完全的
详细说明
Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments.
Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given.
However, previous research has not taken the issue of comorbidity into account.
It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially.
The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile.
By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules.
In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT.
We will also include a control group in the form of a supervised online discussion group who will later receive CBT.
研究类型
介入性
注册 (实际的)
121
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
-
-
-
Linköping、瑞典
- Linköping University, Department of Behavioral Sciences and Learning
-
-
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
不适用
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder
- 15 or more on MADRS-S
Exclusion Criteria:
- Severe depression (more than 35 on MADRS-S or based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Changed medication during the last three months
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:Tailored Internet-delivered CBT
|
This intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed following the diagnostic telephone interview.
These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
|
|
实验性的:Non-tailored Internet-delivered CBT
|
Specific text-based self-help for depression, which has previously been tested in three previous randomized trials.
Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health.
|
|
有源比较器:Online discussion group
|
Participants take part of an online discussion group which are monitored daily.
New discussion topics on depression are introduced every week.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
贝克抑郁量表 (BDI)
大体时间:治疗终止时(10 周)
|
治疗终止时(10 周)
|
|
Beck Depression Inventory (BDI)
大体时间:One week before the treatment starts
|
One week before the treatment starts
|
|
Beck Depression Inventory (BDI)
大体时间:Five weeks after treatment started
|
Five weeks after treatment started
|
|
Beck Depression Inventory (BDI)
大体时间:6 month after treatment ended
|
6 month after treatment ended
|
|
Beck Depression Inventory (BDI)
大体时间:2 years after treatment ended
|
2 years after treatment ended
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
贝克焦虑量表 (BAI)
大体时间:治疗终止时(10 周)
|
治疗终止时(10 周)
|
|
蒙哥马利 Åsberg 抑郁量表自我报告 (MADRS-S)
大体时间:治疗终止时(10 周)
|
治疗终止时(10 周)
|
|
生活质量量表 (QOLI)
大体时间:治疗终止时(10 周)
|
治疗终止时(10 周)
|
|
Beck Anxiety Inventory (BAI)
大体时间:One week before the treatment starts
|
One week before the treatment starts
|
|
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
大体时间:One week before the treatment starts
|
One week before the treatment starts
|
|
Quality of Life Inventory (QOLI)
大体时间:One week before the treatment starts
|
One week before the treatment starts
|
|
Beck Anxiety Inventory (BAI)
大体时间:Five weeks after treatment started
|
Five weeks after treatment started
|
|
Beck Anxiety Inventory (BAI)
大体时间:6 month after treatment ended
|
6 month after treatment ended
|
|
Beck Anxiety Inventory (BAI)
大体时间:2 years after treatment ended
|
2 years after treatment ended
|
|
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
大体时间:Five weeks after treatment started
|
Five weeks after treatment started
|
|
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
大体时间:6 month after treatment ended
|
6 month after treatment ended
|
|
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
大体时间:2 years after treatment ended
|
2 years after treatment ended
|
|
Quality of Life Inventory (QOLI)
大体时间:Five weeks after treatment started
|
Five weeks after treatment started
|
|
Quality of Life Inventory (QOLI)
大体时间:6 month after treatment ended
|
6 month after treatment ended
|
|
Quality of Life Inventory (QOLI)
大体时间:2 years after treatment ended
|
2 years after treatment ended
|
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:Gerhard Andersson, PhD、Department of Behavioral Sciences and Learning, Linköping 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。
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。
研究注册日期
首次提交
2010年8月9日
首先提交符合 QC 标准的
2010年8月12日
首次发布 (估计)
2010年8月13日
研究记录更新
最后更新发布 (估计)
2010年12月28日
上次提交的符合 QC 标准的更新
2010年12月27日
最后验证
2010年12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.