Back to resultsBrain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART) (BE-SMART)
Primary Purpose
Mood Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BE-SMART
Sponsored by
About this trial
This is an interventional treatment trial for Mood Disorders focused on measuring psychotherapy
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.
Sites / Locations
- Mood Disorders Research Program, Yale School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BE-SMART
Arm Description
Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.
Outcomes
Primary Outcome Measures
Changes in functioning of emotional brain circuitry
Functional magnetic resonance imaging measures of the functioning of regions in emotional brain circuitry and the ability to work together (functional connectivity).
Secondary Outcome Measures
Full Information
NCT ID
NCT03183388
First Posted
June 8, 2017
Last Updated
July 21, 2022
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03183388
Brief Title
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Acronym
BE-SMART
Official Title
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders
Keywords
psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It is planned that 72 of the 86 participants who meet criteria for bipolar disorder (BDI, BDII, BD-OS) will complete this combined psychotherapy (BE-SMART) and imaging study. There will be variation of therapies, but no comparison between groups. Actigraphy and ecological momentary assessments on 20 participants will be integrated as part of the supplement to parent grant.
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BE-SMART
Arm Type
Experimental
Arm Description
Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.
Intervention Type
Behavioral
Intervention Name(s)
BE-SMART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in functioning of emotional brain circuitry
Description
Functional magnetic resonance imaging measures of the functioning of regions in emotional brain circuitry and the ability to work together (functional connectivity).
Time Frame
baseline to 6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary P Blumberg, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Research Program, Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
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