Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS)

The goal of this study is to evaluate the feasibility and potential benefit of a behavioral intervention designed to improve emotion regulation in individuals with bipolar disorder. The intervention consists of game-like exercises that involve the 'Cognitive Control of Emotion (CCE) - i.e. the ability to control the influence of emotional information on behavior. Deficits in the cognitive control of emotion are a central feature of Bipolar Disorder that contributes to emotion dysregulation, maladaptive mood episodes, and, ultimately, the overall chronicity and severity of illness. Neuroimaging studies of bipolar patients demonstrate neural abnormalities in brain systems involved in cognitive control and emotion processing. Furthermore, these abnormalities predict mood and behavior problems associated with cognitive control of emotion, such as emotion lability, disinhibited behavior, and extreme mood states. The aim of this study is to determine feasibility and examine whether a computer-based program of progressively difficult cognitive control emotion exercises will improve cognitive control of emotion skills and, thereby, result in better emotion regulation and daily functioning in young adults with bipolar disorder. To test the intervention, a single group of young adults (18-30 years old) with Bipolar I Disorder will complete behavioral assessments before and after 20 hours (4 weeks) of CCE training. In order to identify baseline deficits associated with bipolar disorder, a comparison group of healthy young adults will complete behavioral assessments at a single time-point (without CCE training).

Inclusion/Exclusion Criteria for All Participants Inclusion Criteria.At the time of the consent, the subject MUST:be between 18 and 30 years old, inclusive.have learned English before the age of 12.demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.Exclusion Criteria.At the time of the consent, the subject should NOT:have a history of mental retardation (determined by an IQ<70 based on the WRAT or an equivalent brief IQ test) or pervasive developmental disorder; or other neurological disorder (e.g., epilepsy, Parkinson's disease), or another major medical illness.have a current or recent (within past three months) substance use disorder that is characterized as severe as defined by the DSM-5 criteria and confirmed by the SCID-I or by a score of 37 or more on the AADIS.have had, according to the Traumatic Brain Injury (TBI) interview, a moderate or severe TBI where consciousness is lost for 30 minutes or more, or had three or more mild TBIs where consciousness was lost for more than five minutes on each occasion.have severe and persistent ADHD that was diagnosed in childhood (before the age of 12). Subjects who received a diagnosis of ADHD with onset concurrent with bipolar disorder and/or after age 12, will NOT be excluded.have answered 'yes' to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS or have answered 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" portion shall be excluded from the study if ideation or behavior occurred within two months of consent. Subjects excluded for this reason will be referred for appropriate treatment.Additionally, subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled or discontinued based upon the discretion of the staff evaluator.Additional Inclusion/Exclusion Criteria Specific to Bipolar I Participants Inclusion Criteria. At the time of the consent, the subject MUSTmeet criteria for Bipolar I Disorder, that is not better explained by another psychiatric disorder, including but not limited to a psychotic disorder, substance-induced bipolar disorder, and bipolar disorder due to a medical condition as defined by DSM5 criteria and confirmed by the SCID.have an onset of Bipolar I Disorder within the past five (5) years, with onset being determined by the first time the subject met DSM-5 criteria for Bipolar I Disorder in their lifetime, as determined by the SCID and regardless of a formal diagnosis.receive a score of less than eight (8) on the YMRS and a score of less than 15 on the MADRS according to the Bipolar Inventory of Symptoms Scale (BISS) at the consent visit.have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.Exclusion Criteria.At the time of the consent, the subject should NOT:be in an active illness phase that requires monitoring, intervention, and/or increased psychiatric oversight. Increased psychiatric oversight, may include, but is not limited to:having had a psychiatric hospitalization in the eight (8) weeks prior to consent.changes in psychiatric medication in the eight (8) weeks prior to consent.experiencing four (4) or more episodes of mania and/or depression within the 12 months (i.e. rapid cycling) prior to consent.meet DSM-5 criteria for an episode of mania, hypomania, or depression in the eight (8) weeks prior to consent.have a medication regime consisting of more than four (4) psychotropic medications OR with a high anticholinergic load, defined as benzotropine equivalent greater than two (2) milligrams (Minzenburg et al 2004).have a history of electric convulsive therapy (ECT), transcranial magnetic stimulation (TMS), or deep brain stimulation (DBS).have been treated within 5 years of the date of consent with a computer-based cognitive training programbe participating in a concurrent clinical trial that, in the judgment of the staff evaluator could affect the outcome of this one.Additional Inclusion/Exclusion Criteria Specific to Healthy Subjects Inclusion Criteria.At the time of the consent, the subject MUST:1. have no evidence of past history of manic and/or hypomanic episodes as determined by the clinician and described by DSM Criterion A for each type of episodeManic Episode, Criterion A: A distinct period of abnormally and persistently elevated, expansive, or irritable mood and abnormally and persistently increased activity or energy, lasting at least 1 week and present most of the day, nearly every day (or any duration if hospitalization is necessary).Hypomanic Episode, Criterion A: A distinct period of abnormally and persistently elevated, expansive, or irritable mood and abnormally and persistently increased activity or energy, lasting at least 4 consecutive days and present most of the day, nearly every day.Exclusion CriteriaAt the time of the consent, the subject should NOT:meet for a DSM psychiatric disorder, in the last three monthshave met for a major depressive episode (MDE) in the last year and/or three or more MDEs in their lifetimebe receiving current behavioral treatment focusing on emotion regulation or mood problems (e.g. anger management) and/or psychopharmacological treatment