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

NCT05683431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

Cognitive Control of Emotion (CCE) Training

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.

Sponsors & Collaborators

  • The Ryan Licht Sang Bipolar Foundation

    collaborator UNKNOWN
  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Christine I Hooker, PhD · Rush University Medical Center

  • Kristen M Haut, PhD · Rush University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2020-08-30
Completion
2021-12-16

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683431 on ClinicalTrials.gov