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临床试验/NCT02599597
NCT02599597已完成不适用

Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Lund University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Depressive relapse (change in diagnostic status, SCID-I)

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Fulfilling the criteria for Major depression
  • Bipolar disorder
  • Psychosis
  • Substance abuse
  • Suicidality
  • Currently in psychotherapy

结局指标

主要结局

Depressive relapse (change in diagnostic status, SCID-I)

时间窗: Baseline - 12 months

Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated \& Structured Clinical Interview for DSM IV

Change from baseline in depressive symptoms (MADRS-S)

时间窗: Monthly, 0-12 months

Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

次要结局

  • Change from baseline in the International Physical Activity Questionnaire (IPAQ)(Baseline - 12 months)
  • Morisky Medication Adherence Scale (MMAS-8)(Baseline - 12 months)
  • Time to depressive relapse(Baseline - 12 months)
  • Self reported treatment seeking(Baseline - 12 months)
  • Change from baseline in Outcomes Questionnaire 45 (OQ-45)(Baseline - 12 months)
  • Change from baseline in health related quality of life (EQ-5D)(Baseline - 12 months)
  • Insomnia Severity Index (ISI)(Baseline - 12 months)
  • Alcohol Use Disorder Identification Test (AUDIT)(Baseline - 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olof Johansson

PhD student

Lund University

研究点 (2)

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