Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Completed · Not applicable
Conditions studied: Mood Disorders
In brief
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.
Key facts
- Study ID
- NCT03183388
- Run by
- Yale University
- People needed
- 76
- Starts
- 2017-10-17
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2024-02-29
Who can join
Age: 16 and older, up to 29. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mood Disorders Research Program, Yale School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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