A Randomized Controlled Trial Examining the Efficacy of Metacognitive Training for Depression in Later Life (MCT-Silver)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HRSD-24)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •lifetime psychotic symptoms (i.e., hallucinations, delusions or mania)
- •acute suicidal tendency
- •intellectual disability (estimated IQ < 70)
- •dementia or other neurological illness
研究组 & 干预措施
MCT-Silver
Metacognitive training for depression in later life is a cognitive-behaviorally based group therapy, which focuses on helping participants gain (metacognitive) distance from their thought patterns that contribute to depression. Over 8 modules, MCT-Silver addresses issues specific to depression in later life, such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and (re-)defining values in later life and how one may move toward acceptance of situations that cannot be prevented or changed. MCT-Silver addresses cognitive and metacognitive biases that contribute to the onset and maintenance of depression through fun and engaging exercises, as well as using examples from daily life.
干预措施: MCT-Silver (Behavioral)
Cognitive Remediation
mybraintraining© is a computer-based cognitive remediation program, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The program is administered individually on personal computers and each session lasts approximately 45-60 min. To match the MCT-Silver group, participants will complete up to eight sessions of cognitive remediation.
干预措施: Cognitive Remediation (Behavioral)
结局指标
主要结局
Hamilton Depression Rating Scale (HRSD-24)
时间窗: 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.
次要结局
- 16-item Quick Inventory for Depression (QIDS-C16)(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))
- Stroop Color-Word Task(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))
- Trail-Making Test, Part A(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))
- Rivermead Behavioral Memory Test(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))
- Metacognitions Questionnaire (MCQ-30)(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))
- Rosenberg Self-Esteem Scale(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))
- World Health Organization Quality of Life-BREF - Item 1(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))
- Remission rate(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))
- EurQoL Group 5Q 5D 5L(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))
- Trail-Making Test, Part B(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))
- Dysfunctional Attitudes Scale Form 18B (DAS-18B)(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))
- Ruminative Responses Scale(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))
- Beck Depression Inventory (BDI)(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))
研究者
Prof Dr. Steffen Moritz
Professor; Head of AG Clinical Neuropsychology
Universitätsklinikum Hamburg-Eppendorf