A Trial of Cognitive Training in Euthymic Bipolar Disorder

Sponsor

University of Calgary (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02476331

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Behavioral: Working memory training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

A Randomized Control Trial of Cognitive Training in Euthymic Bipolar Disorder

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

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.	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.
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.

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.

Behavioral: Working memory training

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.

Outcome Measures

Primary Outcome Measures

Working memory capacity [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
Emotion regulation [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the Emotional Stroop task and Emotional N-back task
Fluid intelligence [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the Raven's Progressive Matrices (RPM) task

Secondary Outcome Measures

Depression symptom severity [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)
Manic symptom severity [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the Young Mania Rating Scale (YMRS)
Community functioning [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the Functioning Assessment Short Test (FAST)

Other Outcome Measures

Decision making and impulsivity [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the Delay Discounting Task
Executive functioning: inhibition and set shifting [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with the Delis-Kaplan Executive Functions System (D-KEFS) Color-Word Interference Test
Executive functioning: categorization and set-shifting [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with D-KEFS Sorting Test
Theory of mind reasoning [Change from baseline to post-assessment (after 10 weeks of training)]
Measured with Hinting Task
Motivation [Throughout the 10 weeks of training]
Measured with the Intrinsic Motivation Inventory

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)