Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
2020年3月3日 更新者：Olof Johansson、Lund University
Depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes.
This study evaluates the potential of these methods as prevention of depressive relapse or recurrence
研究概览
研究类型
介入性
注册 (实际的)
150
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
-
-
Skåne
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Malmö、Skåne、瑞典、21431
- Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- A history of at least one episode of Major Depression.
- If medicating - Taking a stable (since one month) and therapeutic dosage of antidepressant medication
- Being able to read and write Swedish
- Having access to the internet
Exclusion Criteria:
- Fulfilling the criteria for Major depression
- Bipolar disorder
- Psychosis
- Substance abuse
- Suicidality
- Currently in psychotherapy
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：预防
- 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 |
|---|---|
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实验性的：Therapist-assisted iCBT
Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse.
Monthly depression screening with therapist feedback.
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13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
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有源比较器：Monthly screening with feedback
Monthly depression screening with therapist feedback.
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Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
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无干预：Control
No intervention, follow-up along with all participants at 6 and 12-months.
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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 |
|---|---|---|
|
Depressive relapse (change in diagnostic status, SCID-I)
大体时间：Baseline - 12 months
|
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
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Baseline - 12 months
|
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Change from baseline in depressive symptoms (MADRS-S)
大体时间：Baseline - 6 months
|
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
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Baseline - 6 months
|
|
Change from baseline in depressive symptoms (MADRS-S)
大体时间：Baseline - 12 months
|
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
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Baseline - 12 months
|
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Change from baseline in depressive symptoms (MADRS-S)
大体时间：Monthly, 0-12 months
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Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
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Monthly, 0-12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in health related quality of life (EQ-5D)
大体时间：Baseline - 3 months
|
Health related quality of life will be measured by an internet based version of the EQ-5D.
|
Baseline - 3 months
|
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Change from baseline in health related quality of life (EQ-5D)
大体时间：Baseline - 6 months
|
Health related quality of life will be measured by an internet based version of the EQ-5D.
|
Baseline - 6 months
|
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Change from baseline in health related quality of life (EQ-5D)
大体时间：Baseline - 9 months
|
Health related quality of life will be measured by an internet based version of the EQ-5D.
|
Baseline - 9 months
|
|
Change from baseline in health related quality of life (EQ-5D)
大体时间：Baseline - 12 months
|
Health related quality of life will be measured by an internet based version of the EQ-5D.
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Baseline - 12 months
|
|
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
大体时间：Baseline - 3 months
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The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role.
It enables the clinician to assess functional level and change over time.
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Baseline - 3 months
|
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Change from baseline in Outcomes Questionnaire 45 (OQ-45)
大体时间：Baseline - 6 months
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The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role.
It enables the clinician to assess functional level and change over time.
|
Baseline - 6 months
|
|
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
大体时间：Baseline - 9 months
|
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role.
It enables the clinician to assess functional level and change over time.
|
Baseline - 9 months
|
|
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
大体时间：Baseline - 12 months
|
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role.
It enables the clinician to assess functional level and change over time.
|
Baseline - 12 months
|
|
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
大体时间：Baseline - 3 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 3 months
|
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
大体时间：Baseline - 6 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 6 months
|
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
大体时间：Baseline - 9 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 9 months
|
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
大体时间：Baseline - 12 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 12 months
|
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Morisky Medication Adherence Scale (MMAS-8)
大体时间：Baseline - 3 months
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Self-reported measure of medication adherence
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Baseline - 3 months
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Morisky Medication Adherence Scale (MMAS-8)
大体时间：Baseline - 6 months
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Self-reported measure of medication adherence
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Baseline - 6 months
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Morisky Medication Adherence Scale (MMAS-8)
大体时间：Baseline - 9 months
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Self-reported measure of medication adherence
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Baseline - 9 months
|
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Morisky Medication Adherence Scale (MMAS-8)
大体时间：Baseline - 12 months
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Self-reported measure of medication adherence
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Baseline - 12 months
|
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Insomnia Severity Index (ISI)
大体时间：Baseline - 3 months
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Insomnia issues
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Baseline - 3 months
|
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Insomnia Severity Index (ISI)
大体时间：Baseline - 6 months
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Insomnia issues
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Baseline - 6 months
|
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Insomnia Severity Index (ISI)
大体时间：Baseline - 9 months
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Insomnia issues
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Baseline - 9 months
|
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Insomnia Severity Index (ISI)
大体时间：Baseline - 12 months
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Insomnia issues
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Baseline - 12 months
|
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Alcohol Use Disorder Identification Test (AUDIT)
大体时间：Baseline - 3 months
|
Baseline - 3 months
|
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Alcohol Use Disorder Identification Test (AUDIT)
大体时间：Baseline - 6 months
|
Baseline - 6 months
|
|
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Alcohol Use Disorder Identification Test (AUDIT)
大体时间：Baseline - 9 months
|
Baseline - 9 months
|
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Alcohol Use Disorder Identification Test (AUDIT)
大体时间：Baseline - 12 months
|
Baseline - 12 months
|
|
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Time to depressive relapse
大体时间：Baseline - 12 months
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Time to depressive relapse is recorded as secondary outcome variable
|
Baseline - 12 months
|
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Self reported treatment seeking
大体时间：Baseline - 12 months
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Treatment seeking among participants is recorded as secondary outcome variable
|
Baseline - 12 months
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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：Lars-Gunnar Lundh, Professor、Lund University, Departement of 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
2016年2月1日
初级完成 (实际的)
2019年12月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2015年11月5日
首先提交符合 QC 标准的
2015年11月5日
首次发布 (估计)
2015年11月6日
研究记录更新
最后更新发布 (实际的)
2020年3月4日
上次提交的符合 QC 标准的更新
2020年3月3日
最后验证
2020年3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.