A Trial of Cognitive Training in Euthymic Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

A Randomized Control Trial of Cognitive Training in Euthymic Bipolar Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02476331
• Other study ID #: REB14-0767
• Status: Not yet recruiting
• Phase: N/A
• First received: June 15, 2015
• Last updated: June 16, 2015
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: June 2015
• Source: University of Calgary
• Contact: Vina M Goghari, PhD
• Phone: (403) 210-7344
• Email: vina.m.goghari[@]ucalgary.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Working memory 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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-19. doi: 10.3390/bs4030301. eCollection 2014 Sep. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decision making and impulsivity	Measured with the Delay Discounting Task	Change from baseline to post-assessment (after 10 weeks of training)	No
Other	Executive functioning: inhibition and set shifting	Measured with the Delis-Kaplan Executive Functions System (D-KEFS) Color-Word Interference Test	Change from baseline to post-assessment (after 10 weeks of training)	No
Other	Executive functioning: categorization and set-shifting	Measured with D-KEFS Sorting Test	Change from baseline to post-assessment (after 10 weeks of training)	No
Other	Theory of mind reasoning	Measured with Hinting Task	Change from baseline to post-assessment (after 10 weeks of training)	No
Other	Motivation	Measured with the Intrinsic Motivation Inventory	Throughout the 10 weeks of training	No
Primary	Working memory capacity	Measured with the Automated Operation Span task (AOSPAN), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span and Maintenance and Manipulation task	Change from baseline to post-assessment (after 10 weeks of training)	No
Primary	Emotion regulation	Measured with the Emotional Stroop task and Emotional N-back task	Change from baseline to post-assessment (after 10 weeks of training)	No
Primary	Fluid intelligence	Measured with the Raven's Progressive Matrices (RPM) task	Change from baseline to post-assessment (after 10 weeks of training)	No
Secondary	Depression symptom severity	Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)	Change from baseline to post-assessment (after 10 weeks of training)	No
Secondary	Manic symptom severity	Measured with the Young Mania Rating Scale (YMRS)	Change from baseline to post-assessment (after 10 weeks of training)	No
Secondary	Community functioning	Measured with the Functioning Assessment Short Test (FAST)	Change from baseline to post-assessment (after 10 weeks of training)	No

External Links

•   Click here for more information about this study: A Randomized Control Trial of Cognitive Training in Bipolar Disorder