- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476331
A Trial of Cognitive Training in Euthymic Bipolar Disorder
May 14, 2016 updated by: Vina M. Goghari, University of Calgary
A Randomized Control Trial of Cognitive Training in Euthymic Bipolar Disorder
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working memory capacity
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the Automated Operation Span task (AOSPAN), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span and Maintenance and Manipulation task
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Change from baseline to post-assessment (after 10 weeks of training)
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Emotion regulation
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the Emotional Stroop task and Emotional N-back task
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Change from baseline to post-assessment (after 10 weeks of training)
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Fluid intelligence
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the Raven's Progressive Matrices (RPM) task
|
Change from baseline to post-assessment (after 10 weeks of training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression symptom severity
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)
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Change from baseline to post-assessment (after 10 weeks of training)
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Manic symptom severity
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the Young Mania Rating Scale (YMRS)
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Change from baseline to post-assessment (after 10 weeks of training)
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Community functioning
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the Functioning Assessment Short Test (FAST)
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Change from baseline to post-assessment (after 10 weeks of training)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decision making and impulsivity
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
|
Measured with the Delay Discounting Task
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Change from baseline to post-assessment (after 10 weeks of training)
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Executive functioning: inhibition and set shifting
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with the Delis-Kaplan Executive Functions System (D-KEFS) Color-Word Interference Test
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Change from baseline to post-assessment (after 10 weeks of training)
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Executive functioning: categorization and set-shifting
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with D-KEFS Sorting Test
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Change from baseline to post-assessment (after 10 weeks of training)
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Theory of mind reasoning
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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Measured with Hinting Task
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Change from baseline to post-assessment (after 10 weeks of training)
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Motivation
Time Frame: Throughout the 10 weeks of training
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Measured with the Intrinsic Motivation Inventory
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Throughout the 10 weeks of training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vina Goghari, University of Calgary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
June 15, 2015
First Submitted That Met QC Criteria
June 16, 2015
First Posted (Estimate)
June 19, 2015
Study Record Updates
Last Update Posted (Estimate)
May 17, 2016
Last Update Submitted That Met QC Criteria
May 14, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB14-0767
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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