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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03183388
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 21, 2021
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Mood Disorders Behavioral: BE-SMART Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

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.

Primary Outcome Measures :
  1. Changes in functioning of emotional brain circuitry [ Time Frame: baseline to 6 and 12 weeks ]
    Functional magnetic resonance imaging measures of the functioning of regions in emotional brain circuitry and the ability to work together (functional connectivity).

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03183388

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Contact: Susan Quatrano, BA +1 (203) 785-7875

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United States, Connecticut
Mood Disorders Research Program, Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: Hilary Blumberg, M.D.    203-785-6180   
Contact: Susan Quatrano    203-785-7875   
Principal Investigator: Hilary Blumberg, MD         
Sub-Investigator: Wendy Silverman, PhD         
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
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Principal Investigator: Hilary P Blumberg, MD Yale School of Medicine
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Responsible Party: Yale University Identifier: NCT03183388    
Other Study ID Numbers: 0407026910
R61MH111929 ( U.S. NIH Grant/Contract )
3UG3MH111929-02S1 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Additional relevant MeSH terms:
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Mood Disorders
Mental Disorders