N/A
N=60
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Mood Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03183388 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention — 1.62; -1.42 BOLD signal — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BE-SMART (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention |
1.62; -1.42 | 0.0001 sig |
| PRIMARY FMRI BOLD Signal Changes in Left Amygdala at Baseline and Midpoint |
1.42; 0.053 | 0.60 |
| PRIMARY fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Endpoint |
-0.057; 0.052 | 0.0001 sig |
| PRIMARY fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Midpoint |
-0.038; -0.0068 | 0.58 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03183388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.