At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of Bipolar Disorder Type I, Type II, or Other Specified Bipolar Disorder (BD-OS) per DSM-5 criteria
- ✓Active mood symptoms: depression (Ham-D score ≥15) and/or hypomania/mild mania (YMRS ≥12)
- ✕History of significant medical illness, particularly conditions associated with changes in cerebral tissue or cerebrovasculature (e.g., hypertension)
- ✕History of neurologic abnormality including significant head trauma (≥5 minutes loss of consciousness), seizure disorder, cerebrovascular or neoplastic lesion, or neurodegenerative disorder
- ✕Contraindication to MRI scanning (ferromagnetic objects, orthodontic braces, claustrophobia)
- ✕Intelligence quotient (IQ) lower than 70
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
In Brief
A clinical study evaluating BE-SMART for Mood Disorders. Completed, enrolled 76 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Participants will take part in 12 therapy sessions, at a rate of about 1 session every one to two weeks. Sessions are anticipated to last about 1 hour each. Sessions may be focused on teaching skills to regulate emotions or regularize sleep and activity. These therapy sessions may be videotaped and audiotaped (only with the expressed written consent of the participant, and when appropriate, the participant's parent or guardian). Participants will be asked to complete worksheets and practice the skills learned from these sessions and will be asked questions about feelings. There will be an interview, assessments and scanning performed prior to treatment and at the midpoint and end to assess progress. The intervening 9 sessions may be by video telecommunication. Participants may be given devices to track actigraphy and ecological momentary assessments.