A Trial of Cognitive Training in Euthymic Bipolar Disorder

NCT02476331 | Withdrawn

• 1 other identifier: REB14-0767
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Cognitive training; Working memory; Emotion regulation

Outcome Measures

Primary Outcomes (3)

• 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)

• Emotion regulation

  Measured with the Emotional Stroop task and Emotional N-back task

  Change from baseline to post-assessment (after 10 weeks of training)

• Fluid intelligence

  Measured with the Raven's Progressive Matrices (RPM) task

  Change from baseline to post-assessment (after 10 weeks of training)

Secondary Outcomes (3)

• Depression symptom severity

  Change from baseline to post-assessment (after 10 weeks of training)

• Manic symptom severity

  Change from baseline to post-assessment (after 10 weeks of training)

• Community functioning

  Change from baseline to post-assessment (after 10 weeks of training)

Other Outcomes (5)

• Decision making and impulsivity

  Change from baseline to post-assessment (after 10 weeks of training)

• Executive functioning: inhibition and set shifting

  Change from baseline to post-assessment (after 10 weeks of training)

• Executive functioning: categorization and set-shifting

  Change from baseline to post-assessment (after 10 weeks of training)

Study Arms (2)

Cognitive training

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Working memory training BEHAVIORAL

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.

Cognitive training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

• Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-319. doi: 10.3390/bs4030301. eCollection 2014 Sep.

  PMID: 25379283 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Vina Goghari

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 19, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

CA (1)