Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
研究概览
简要总结
People with serious mental illness often experience difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is helpful in improving a specific type of memory skill in people who have mental health conditions.
The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training.
Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
- •Willingness to participate in study procedures
排除标准
- •History of neurological illness or injury (e.g., stroke)
- •History of loss of consciousness
- •Diagnosed intellectual disability
- •Current substance use disorder
- •Current mania or moderate depression or severe psychosis
- •Current serious suicidal ideation/behavior
- •Pregnant or trying to become pregnant, or currently lactating
研究组 & 干预措施
Active stimulation + cognitive training
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
干预措施: tDCS (Active) (Device)
Active stimulation + cognitive training
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
干预措施: BrainHQ (Behavioral)
Inactive stimulation + cognitive training
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
干预措施: BrainHQ (Behavioral)
Inactive stimulation + cognitive training
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
干预措施: tDCS (Inactive) (Device)
结局指标
主要结局
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
时间窗: Baseline to post-treatment (up to 4 weeks)
MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score
时间窗: Baseline to post-treatment (up to 4 weeks)
MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).
次要结局
- Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A(Baseline to post-treatment (up to 4 weeks))
- Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B(Baseline to post-treatment (up to 4 weeks))
研究者
Cynthia Burton
Clinical Assistant Professor, Department of Psychiatry
University of Michigan