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Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)

  • Study HIC#:0407026910
  • Last Updated:08/11/2021

New treatments to help to reduce the emotional dysregulation of mood disorders are critically needed. This is a study of an emotional dysregulation psychotherapy treatment in which subjects will learn skills to help to down-regulate maladaptive emotional responses and learn beneficial, healthy habits. Investigators will perform symptom and behavioral assessments and scanning prior to the treatment and will then repeat scanning, symptom and behavioral assessments at the midpoint, and after the psychotherapy is completed. This collected information will assess whether the treatment can improve functioning of emotion regulation brain circuitry.

  • Age16 years - 24 years
  • GenderBoth
  • Start Date08/18/2004
  • End Date06/30/2021

Trial Purpose and Description

New treatments to help to reduce the emotional dysregulation of mood disorders are critically needed. This is a study of an emotional dysregulation psychotherapy treatment in which subjects will learn skills to help to down-regulate maladaptive emotional responses and learn beneficial, healthy habits. Investigators will perform symptom and behavioral assessments and scanning prior to the treatment and will then repeat scanning, symptom and behavioral assessments at the midpoint, and after the psychotherapy is completed. This collected information will assess whether the treatment can improve functioning of emotion regulation brain circuitry.

Eligibility Criteria

Inclusion Criteria:

  • subjects meeting DSM5 criteria for BDI, BDII or BD Other Specified Bipolar (BD-OS).
  • Subjects with mood symptoms, such as Ham-D score ≥ 15 and/or for hypomania/mild mania YMRS ≥ 12.

Exclusion Criteria:

  • history of significant medical illness, particularly illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g. hypertension)
  • history of neurologic abnormality, including significant head trauma (defined by loss of consciousness of ≥5-minutes duration), seizure disorder, cerebrovascular or neoplastic lesion, or neurodegenerative disorder.
  • contraindication to MRI scanning, e.g. presence of a ferromagnetic object, including orthodontic braces, or claustrophobia.
  • IQ lower than 70
  • pregnancy
  • alcohol or other substance dependence in the year prior to study, abuse in the 6 months prior to study, or illicit substance use in the week prior to study.

Principal Investigator

Sub-Investigators

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