Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Participant-rated Acceptability of Combination Therapy
研究概览
简要总结
People with serious mental illness often report 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 acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.
This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.
Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(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
- •Objective cognitive impairment in working memory
- •Willingness to complete computerized cognitive training and undergo brain stimulation procedures
排除标准
- •History of neurological illness or brain injury (e.g., stroke)
- •History of loss of consciousness
- •Diagnosed intellectual disability
- •Current substance use disorder
- •Current mania or moderate depression or severe psychosis
- •Serious suicidal ideation/behavior
- •Pregnant or trying to become pregnant, or currently lactating
研究组 & 干预措施
Dual Therapy First
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
干预措施: tDCS (Device)
Dual Therapy First
Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
干预措施: BrainHQ (Other)
Mono Therapy First
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
干预措施: tDCS (Device)
Mono Therapy First
Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
干预措施: BrainHQ (Other)
结局指标
主要结局
Participant-rated Acceptability of Combination Therapy
时间窗: 8 weeks
Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)
Participant Retention in Combination Treatment
时间窗: 4 weeks
Number of participants completing every session of the combined phase of treatment
次要结局
未报告次要终点
研究者
Cynthia Burton
Clinical Lecturer, Department of Psychiatry
University of Michigan
