A Randomized Control Trial of Cognitive Training in Euthymic Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Working memory capacity
研究概览
简要总结
Bipolar disorder (BD) is characterized by extreme changes in mood and emotion dysregulation. Mood changes are episodic in nature, with distinct periods of mania, depression, and asymptomatic periods of euthymia. In addition to impairments in mood, cognitive impairments are a common feature of the disorder. These cognitive impairments persist during periods of euthymia and are associated with negative clinical and psychosocial outcomes. Specifically, individuals with BD show impairments in executive functions. Recent studies show that emotion regulation can be down-regulated by taxing executive functions, and it can be improved with working memory training, a specific component of executive functions. These initial studies show that emotion regulation is under executive control in healthy individuals; however, the nature of this relationship is not well understood in populations that are affected by impairments in both executive control and emotion regulation. Previous work on cognitive training has not targeted specific cognitive domains with an emphasis on understanding the underlying mechanisms that promote change. Moreover, well-controlled randomized control trial (RCT) studies are needed in order to provide high quality evidence to inform the efficacy of cognitive training interventions for psychiatric populations. The aim of the proposed study is to use a commercially available cognitive training program to study the effects of working memory training on cognitive, clinical, and psychosocial outcomes in patients with BD. We hypothesize that training working memory will lead to improvements in cognitive and emotional functioning, leading to downstream changes that will positively impact untrained outcomes, such as mood and community functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Male or female
- •Age between 18 and 65 years
- •Clinically diagnosed with bipolar disorder I or bipolar disorder II and currently in a euthymic state
- •Normal, or corrected to normal, vision and hearing
- •Able to provide informed consent
排除标准
- •Meeting Diagnostic and Statistical Manual 5th edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode
- •Past electroconvulsive therapy (ECT)
- •Past Transcranial Magnetic Stimulation therapy (TMS)
- •Past 3 month history of substance abuse
- •Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)
- •Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)
研究组 & 干预措施
Cognitive training
The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). The experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games provided by BrainGymmer are adaptive, meaning that the level of difficulty increases as users develop expertise on a given task. Participants randomized to the cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
干预措施: Working memory training (Behavioral)
Control
The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, participants will complete post-testing assessments.
结局指标
主要结局
Working memory capacity
时间窗: Change from baseline to post-assessment (after 10 weeks of training)
Measured with the Automated Operation Span task (AOSPAN), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span and Maintenance and Manipulation task
Fluid intelligence
时间窗: Change from baseline to post-assessment (after 10 weeks of training)
Measured with the Raven's Progressive Matrices (RPM) task
Emotion regulation
时间窗: Change from baseline to post-assessment (after 10 weeks of training)
Measured with the Emotional Stroop task and Emotional N-back task
次要结局
- Depression symptom severity(Change from baseline to post-assessment (after 10 weeks of training))
- Manic symptom severity(Change from baseline to post-assessment (after 10 weeks of training))
- Community functioning(Change from baseline to post-assessment (after 10 weeks of training))
研究者
Vina M. Goghari
Dr.
University of Calgary