Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
研究概览
简要总结
To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).
详细描述
The study will involve a randomized, controlled, double-blind trial to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games). Moodify is comprised of a novel continuous performance task (CPT) to improve cognitive slowing and lethargy often present in cases of major depressive disorder. This training method is based on an existing, validated cognitive training paradigm (tonic and phasic attention training, TAPAT1; WIRB Study No. 1126399). Moodify will also employ two additional cognitive training modules previously validated in this and other clinical populations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must 18 to 85 years or older and not pregnant
- •Participants must be fluent in English
- •Participants must be able to engage with computerized cognitive tasks as required in order to participate in this study.
- •Normal vision (or corrected to normal vision)
- •Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
- •Participants must meet diagnostic criteria for MDD
排除标准
- •Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard
- •Participants unable to perform neuropsychological evaluations
- •Participants cannot comprehend or follow instructions
- •Participants not capable of giving informed consent
- •Participants who appear to be intoxicated or under the influence of a controlled substance
- •Participants with a history of significant medical diseases or multiple neurological events of the head
- •Participants with serious or unstable medical illness (e.g. cardiovascular, hepatic, renal, endocrine, neurologic disease)
- •Participants with a history or current diagnosis to specific Diagnostic and Statistical Manual (DSM)-IV psychiatric illness such as (but not limited to): organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder Not Otherwise Specific, bipolar disorder, substance dependence and substance abuse
- •Participants with a history of seizure disorder
研究组 & 干预措施
Experimental Treatment
Computerized plasticity-based adaptive cognitive training (Moodify) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
干预措施: Computerized Plasticity-Based Adaptive Cognitive Training (Other)
Active Comparator
Commercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
干预措施: Commercially available computerized training (Other)
结局指标
主要结局
Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
时间窗: 3 months and 6 months
Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
时间窗: 3 months and 6 months
Change scores for depressive symptoms using Beck Depression Scale (BDI)
时间窗: 3 months and 6 months
Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
时间窗: 3 months and 6 months
次要结局
未报告次要终点