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

Yale University

Status: Completed

Conditions: Mood Disorders

Treatments: Behavioral: BE-SMART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03183388

0407026910

R61MH111929 (U.S. NIH Grant/Contract)

3UG3MH111929-02S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 participants 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.

Full description

Aim: To use functional magnetic resonance imaging (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.

At the time of registration, the primary outcome "Changes in Functioning of Emotional Brain Circuitry" was the only outcome registered. This outcome is comprised of multiple measurements and was split up individually at the time of results entry and the original primary outcome measure was deleted.

Enrollment: 76 patients

Sex: All

Ages: 16 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participants meeting Diagnostic and Statistical Manual Fifth Edition (DSM-5) criteria for BDI, BDII or BD Other Specified Bipolar (BD-OS).
• participants with mood symptoms, such as Hamilton Depression Rating Scale (Ham-D) score ≥ 15 and/or for hypomania/mild mania such as Young Mania Rating Scale (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.
• intelligence quotient (IQ) lower than 70
• pregnancy
• alcohol/substance use may be permitted if participant does not meet for DSM-5 current use disorder but will not be permitted for illicit substance use in the week prior to study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

BE-SMART

Experimental group

Description:

Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.

Treatment:

Behavioral: BE-SMART