Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
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.
干预措施: Therapist-assisted iCBT (Behavioral)
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.
干预措施: Monthly screening with feedback (Behavioral)
Monthly screening with feedback
Monthly depression screening with therapist feedback.
干预措施: Monthly screening with feedback (Behavioral)
Control
No intervention, follow-up along with all participants at 6 and 12-months.
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.
Change from baseline in depressive symptoms (MADRS-S)
时间窗: Baseline - 6 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Change from baseline in depressive symptoms (MADRS-S)
时间窗: Baseline - 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)
- Alcohol Use Disorder Identification Test (AUDIT)(Baseline - 9 months)
- Change from baseline in health related quality of life (EQ-5D)(Baseline - 3 months)
- Change from baseline in health related quality of life (EQ-5D)(Baseline - 6 months)
- Alcohol Use Disorder Identification Test (AUDIT)(Baseline - 3 months)
- Change from baseline in health related quality of life (EQ-5D)(Baseline - 9 months)
- Change from baseline in Outcomes Questionnaire 45 (OQ-45)(Baseline - 3 months)
- Alcohol Use Disorder Identification Test (AUDIT)(Baseline - 6 months)
- Change from baseline in Outcomes Questionnaire 45 (OQ-45)(Baseline - 6 months)
- Change from baseline in Outcomes Questionnaire 45 (OQ-45)(Baseline - 9 months)
- Change from baseline in the International Physical Activity Questionnaire (IPAQ)(Baseline - 3 months)
- Change from baseline in the International Physical Activity Questionnaire (IPAQ)(Baseline - 6 months)
- Change from baseline in the International Physical Activity Questionnaire (IPAQ)(Baseline - 9 months)
- Morisky Medication Adherence Scale (MMAS-8)(Baseline - 3 months)
- Morisky Medication Adherence Scale (MMAS-8)(Baseline - 6 months)
- Morisky Medication Adherence Scale (MMAS-8)(Baseline - 9 months)
- Insomnia Severity Index (ISI)(Baseline - 3 months)
- Insomnia Severity Index (ISI)(Baseline - 6 months)
- Insomnia Severity Index (ISI)(Baseline - 9 months)