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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:16 - 24
Updated:1/13/2018
Start Date:October 17, 2017
End Date:June 30, 2019
Contact:Susan Quatrano, BA
Email:susan.quatrano@yale.edu
Phone:+1 (203) 785-7875

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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.

Aim: To use fMRI, before, at mid point, and after an emotional regulation intervention, to
assess intervention-associated changes in brain circuitry responses to emotional stimuli.

Hypothesis : The emotional regulation psychotherapy treatment will be associated with changes
in emotional regulation circuitry.

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.
We found this trial at
1
site
333 Cedar Street
New Haven, Connecticut 06511
Principal Investigator: Hilary Blumberg, MD
Phone: 203-785-6180
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mi
from
New Haven, CT
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