Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Emotional Go/No Go Task (fMRI)
研究概览
简要总结
The purpose of the study is to examine the benefits and mechanism of action of computerized cognitive training (CCT) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current diagnosis of MDD/persistent depressive disorder or HDRS greater than or equal to
- •Daily access to smartphone or tablet with internet connection for the study duration.
- •Willing and able to complete MRI, mood, and neuropsychological testing.
排除标准
- •Lacks English-speaking ability as determined by self-report and clinical evaluation.
- •Evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar I and II disorder.
- •Active suicidal ideation, intent, or plan, or past attempt within 1 year.
- •Severe depression (HDRS > 30).
- •Neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke).
- •Use of medications known to have negative impact on cognition (benzodiazepines and lorazepam equivalents > 1mg daily, narcotics, anticholinergics).
- •History of alcohol or drug abuse or dependence within past year.
- •Acute, severe, unstable medical illness. For cancer, acutely ill patients (including those with metastases) are excluded, but past history of successfully treated cancer does not result in exclusion.
- •Regular online brain training or regular player of non-fluency verbal games, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening.
结局指标
主要结局
Change in Emotional Go/No Go Task (fMRI)
时间窗: Week 0, Week 4 or Week 8 (depending on randomization)
Measure of behavioral inhibition and set shifting. Participants must press a button for pre-specified to go trials and withhold pressing the button for pre-specified no-go trials.
Change in Sheehan Disability Scale
时间窗: Screen, Week 0, Week 4, Week 8, 3-month follow-up
Self-report questionnaire of everyday functioning. It includes three subscales: work, social life, leisure activities, and home life or family responsibilities. Each subscale is rated on a 10-point scale for a minimum total score of 0 and a maximum total summed score of 30 across the three subscales. High scores are associated with more impairment.
Change in Hamilton Depression Rating Scale
时间窗: Screen, Week 0, Week 4, Week 8, 3-month follow-up
Clinician-rated measure of depression composed of 21 questions. The first 17 items are scored: eight items have a 5-point scale, nine items have a 3-point scale. Total score range is 0-52. Higher scores indicate more severe symptoms.
Change in DKEFS Trail Making Test - Condition 4
时间窗: Weeks 0, 4, 8, 3-month follow- up
Measure of executive function. It is a switching task that requires the subject to connect numbers and letters in an alternating pattern (1-A-2-B, etc.) as quickly as possible.
次要结局
- Change in Beck Depression Inventory-II(Screen, weekly for weeks 0-8, 3-month follow-up)
- Change in WAIS-IV Coding(Weeks 0, 4, 8, 3-month follow- up)
- Change in Connectivity Index (resting state fMRI)(Week 0, Week 4 or Week 8 (depending on randomization))