Games to Overcome Late Life Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in depression over time
研究概览
简要总结
This is a pilot study divided into two phases. IN phase 1 (completed) participants will be randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now recruiting), participants will be randomized to Evo, PST, and a different cognitive training program called Words. Words is similar to Evo in that it is an adaptive training program and includes case management. IN both studies participants will be assessed for clinical and functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.
详细描述
Evo is a computer game that targets parts of the brain (i.e. the cognitive control network) that we think may be associated with depressive symptoms. This study is exploratory and will inform future hypotheses the research team will test in subsequent research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 60-80 years of age
- •Meets criteria for Major Depressive Disorder
- •Hamilton Depression Rating Scale (HDRS) of 20 or greater
- •Mini Mental State Exam score of 24 or greater
- •Can speak and read English
- •Able to physically participate in the research protocol (e.g.: is not suffering from a terminal or highly disabling illness)
- •Can participate in MRI scans
- •Able to provide written informed consent
排除标准
- •History of psychosis, mania, or currently using or abusing illicit drugs or alcohol
- •Diagnosis of dementia
- •Taking cognitive enhancers
- •Change in or newly began taking psychiatric medication within the last 6 months
- •Metal in the body that cannot be removed
- •Color blind
- •Movement disorder that prevents participation -
研究组 & 干预措施
Problem Solving Therapy
Problem Solving Therapy is an evidence-based behavioral treatment for late life depression proven effective with different geriatric groups including ambulatory; medically ill; older adults with executive dysfunctions; and more recently, low-income, disabled older adults.
干预措施: Problem Solving Therapy (Behavioral)
Evolution
Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.
干预措施: Evolution (Behavioral)
Words
Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo.
干预措施: Words (Behavioral)
结局指标
主要结局
Change in depression over time
时间窗: weeks 0, 4, 8, 24
Hamilton Depression Rating Scale
次要结局
未报告次要终点
研究者
Pat Arean
Professor, Psychiatry and Behavioral Sciences
University of Washington