Clinical trial NCT02476331: A Trial of Cognitive Training in Euthymic Bipolar Disorder
Official title: A Randomized Control Trial of Cognitive Training in Euthymic Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar Disorder
Keywords: Cognitive training
Working memory
Emotion regulation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Working memory capacity
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Emotion regulation
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Fluid intelligence
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
Secondary outcomes:
measure: Depression symptom severity
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Manic symptom severity
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Community functioning
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
Other outcomes:
measure: Decision making and impulsivity
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Executive functioning: inhibition and set shifting
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Executive functioning: categorization and set-shifting
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Theory of mind reasoning
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Motivation
timeFrame: Throughout the 10 weeks of training
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Vina Goghari
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.