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

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 Overview

• Status: Completed
• Conditions: Mood Disorders
• Intervention / Treatment: Behavioral: BE-SMART

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Mood Disorders Research Program, Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BE-SMART; Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.

Behavioral: BE-SMART; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention	FMRI was performed during an emotional face processing task. Signal differences (BOLD changes) were compared between baseline and endpoint, separately for BE-SMART-DR or BE-SMART-ER, at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If voxels above this threshold survived in a hypothesized region of interest (amygdala and ventral prefrontal cortex, VPFC) then the signal differences in those voxels were extracted and mean values within the region for each subject were used in the analyses below. The only voxel-based finding meeting criteria was left amygdala activation decreases to fearful faces in participants receiving BE-SMART-DR. The results of the mixed model analysis of those values are below.	baseline and 12 weeks
FMRI BOLD Signal Changes in Left Amygdala at Baseline and Midpoint	Signal differences (BOLD changes) between baseline and midpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI activation analyses. The results of the mixed model analyses of those values are below.	Baseline and 6 weeks
fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Endpoint	Pearson's correlations between the mean timecourse of the seed and the timecourse of each voxel between baseline and endpoint were compared at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If there were voxels above this threshold in the hypothesized region of interest (ventral prefrontal cortex), then the correlation values from those voxels in that region were extracted and Fisher transformed and averaged, where higher scores indicted greater connectivity. Functional connectivity differences between baseline and endpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI functional connectivity analyses. The results of the mixed model analysis of those values are below.	Baseline and 12 weeks
fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Midpoint	Pearson's correlations between the mean timecourse of the seed and the timecourse of each voxel between baseline and midpoint were compared at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If there were voxels above this threshold in the hypothesized region of interest (ventral prefrontal cortex), then the correlation values from those voxels in that region were extracted and Fisher transformed and averaged where higher scores indicte greater connectivity. Functional connectivity differences between baseline and midpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI functional connectivity analyses. The results of the mixed model analysis of those values are below.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Hilary P Blumberg, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: 0407026910; R61MH111929 (U.S. NIH Grant/Contract); 3UG3MH111929-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No