Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)
赞助:
Universitätsklinikum Hamburg-Eppendorf
合作者:
信息的提供 (责任方):
Prof Dr. Steffen Moritz,Universitätsklinikum Hamburg-Eppendorf
追踪信息 | |||
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首次提交日期 ICMJE | September 25, 2018 | ||
首次发布日期e ICMJE | October 1, 2018 | ||
最后更新发布日期 | October 1, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | September 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Hamilton Depression Rating Scale (HRSD-24)[ Time Frame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) ] The 24-item version of the Hamilton Depression Rating Scale is an established clinician-rated assessment of depressive symptom severity and assesses psychological as well as somatic symptoms (scores range from 0-2 or 0-4) of depression. The clinician rates the severity of these symptoms based on the patient's report and his or her own observation. Scores range from 0-54. Based on the first 17 items, a score of 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression and scores greater than 23 indicate very severe depression. The scale has demonstrated good sensitivity and specificity among older adults (Mottram, Wilson & Copeland, 2001). The reliability and validity among older adult samples has also been confirmed (Korner et al., 2006). In terms of assessing change for the current trial, a greater reduction in depressive symptoms (i.e., change score) indicates better outcome. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver) | ||
正式标题 ICMJE | A Randomized Controlled Trial Examining the Efficacy of Metacognitive Training for Depression in Later Life (MCT-Silver) | ||
简要概况 | The study will evaluate the efficacy of metacognitive training for depression in later life (MCT-Silver) vs. cognitive remediation (mybraintraining©) in reducing depressive symptoms among older adults. |
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详细说明 | The study examines the efficacy of Metacognitive Training for depression in later life (MCT-Silver). The study intends to investigate the extent to which MCT-Silver leads to a significant reduction in depressive symptoms compared to an active control group (mybraintraining©) (primary outcome: change in clinician-assessed depressive symptoms from t0 to t1 and t2). Secondary outcomes include change in self-reported depressive symptoms and dysfunctional (meta) cognitive beliefs, as well as quality of life, rumination, self-reported anxiety, attitudes toward aging and neuropsychological functioning from t0 to t1 and t2. The study design is a randomized-controlled trial with one intervention group and one active control group. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述:Double blind 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
86 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | September 2020 | ||
预计主要完成日期 | September 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Able to give informed consent - age 60 years or older - diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI) - sufficient command of the German language - willingness to participate in intervention over a period of 8 weeks (participants who do not attend the intervention will also be included in the analysis) - Visual and auditory acuity adequate for neuropsychological testing and participation in group sessions Exclusion Criteria: - lifetime psychotic symptoms (i.e., hallucinations, delusions or mania) - acute suicidal tendency - intellectual disability (estimated IQ < 70) - dementia or other neurological illness | ||
性别 |
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年龄 | 最小年龄:60 Years ,最大年龄:100 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Prof Dr. Steffen Moritz,Universitätsklinikum Hamburg-Eppendorf | ||
研究赞助商 ICMJE | Universitätsklinikum Hamburg-Eppendorf | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Universitätsklinikum Hamburg-Eppendorf | ||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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