An interventional study of Working memory training in Bipolar Disorder, sponsored by University of Calgary. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by University of Calgary · Not applicable, Interventional, and Supportive care
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
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Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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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.
Behavioral: Working memory training
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.
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.
Working memory capacity
Measured with the Automated Operation Span task (AOSPAN), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span and Maintenance and Manipulation task
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Emotion regulation
Measured with the Emotional Stroop task and Emotional N-back task
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Fluid intelligence
Measured with the Raven's Progressive Matrices (RPM) task
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Depression symptom severity
Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Manic symptom severity
Measured with the Young Mania Rating Scale (YMRS)
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Community functioning
Measured with the Functioning Assessment Short Test (FAST)
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Decision making and impulsivity
Measured with the Delay Discounting Task
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Executive functioning: inhibition and set shifting
Measured with the Delis-Kaplan Executive Functions System (D-KEFS) Color-Word Interference Test
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Executive functioning: categorization and set-shifting
Measured with D-KEFS Sorting Test
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Theory of mind reasoning
Measured with Hinting Task
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Motivation
Measured with the Intrinsic Motivation Inventory
Time frame: Throughout the 10 weeks of training
This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of Calgary