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Withdrawn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

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre

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.

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)
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)
Emotion regulation
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with the Emotional Stroop task and Emotional N-back task
Change from baseline to post-assessment (after 10 weeks of training)
Fluid intelligence
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
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)
Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)
Change from baseline to post-assessment (after 10 weeks of training)
Manic symptom severity
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with the Young Mania Rating Scale (YMRS)
Change from baseline to post-assessment (after 10 weeks of training)
Community functioning
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with the Functioning Assessment Short Test (FAST)
Change from baseline to post-assessment (after 10 weeks of training)

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
Change from baseline to post-assessment (after 10 weeks of training)
Executive functioning: inhibition and set shifting
Time Frame: 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
Change from baseline to post-assessment (after 10 weeks of training)
Executive functioning: categorization and set-shifting
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with D-KEFS Sorting Test
Change from baseline to post-assessment (after 10 weeks of training)
Theory of mind reasoning
Time Frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with Hinting Task
Change from baseline to post-assessment (after 10 weeks of training)
Motivation
Time Frame: Throughout the 10 weeks of training
Measured with the Intrinsic Motivation Inventory
Throughout the 10 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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