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

NCT05683431 | Completed

• 1 other identifier: 17042901
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bipolar Disorder; Bipolar I Disorder; Bipolar Affective Disorder; Bipolar Disorder I; Bipolar Depression

Keywords

Bipolar; Emotion; Cognitive Control; Affect; Impulsivity; Neuroimaging; Targeted Cognitive Training

Outcome Measures

Primary Outcomes (2)

• Feasibility of CCE training program

  Participants completed the Intrinsic Motivation Questionnaire to assess enjoyment, usability, and motivation. Rating scale is 1 to 7. An average rating of 4 or above is taken as evidence of feasibility.

  4 weeks

• Change in Cognitive Control of Emotion (CCE)

  A main outcome measure for the study is the Change (from pre-to-post intervention) in Cognitive Control of Emotion (CCE) skills. CCE skills are assessed using the appropriate performance metric for each CCE training exercise (e.g. reaction time, accuracy, number of objects remembered, etc.). Individual performance on each of the 5 CCE exercises is measured at the first session of the intervention (i.e. baseline performance) and after the 20th session (approx 4 weeks). Change in CCE is calculated by subtracting the individual's pre-intervention/baseline score from their post-intervention score (i.e. Post intervention score - Pre intervention score = Change Score). One-sample t-tests are used to determine whether the Change Score is significantly different than zero. A significant result indicates that the intervention program had an effect on CCE - the targeted cognitive process.

  4 weeks

Study Arms (1)

Cognitive Control of Emotion (CCE) Training

EXPERIMENTAL

Mobile (iphone/ipad) "App" with game-like exercises designed to improve Cognitive Control of Emotion (CCE), i.e. the ability to control the influence of emotional information on behavior. Participants do 20 sessions (approximately 30min each), over 4 weeks.

Behavioral: Cognitive Control of Emotion (CCE) Training

Interventions

Cognitive Control of Emotion (CCE) Training BEHAVIORAL

Training consists of game-like exercises using a software program developed in collaboration with PositScience Corporation (using BrainHQ platform ) - which has exercises targeting cognition and social cognition. The CCE training program incorporates characteristics that optimize learning-induced neuroplasticity - most importantly, exercises are short \& rewarding, adapt to individual skill-level, and become increasingly difficult as performance improves. There are 5 CCE exercises that are organized in half-hour sessions and proceed in a predetermined sequence.

Also known as: Cognitive Control of Emotion Training using a BrainHQ smartphone "App" developed by Posit Science

Cognitive Control of Emotion (CCE) Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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.
• meet 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• The Ryan Licht Sang Bipolar Foundation: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60618, United States

Location

Related Publications (9)

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  BACKGROUND

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  PMID: 2926629 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Impulsive Behavior

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavior

Study Officials

• Christine I Hooker, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Kristen M Haut, PhD

  Rush University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, 'open label' study to examine the feasibility and potential target engagement (i.e. potential benefit) of a behavioral smartphone-based cognitive training program for individuals with bipolar I disorder. Participants with bipolar disorder are assessed before and after the 20 session/4 week intervention. In addition, a comparison group of healthy adults (without bipolar disorder) are assessed at a single time-point as a means of identifying baseline deficits associated with bipolar disorder. Participants in the healthy comparison group do not complete the intervention. (Thus, Number of Intervention Arms = 1.)

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: January 13, 2023
• Study Start: March 22, 2019
• Primary Completion: August 30, 2020
• Study Completion: December 16, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)