Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART) (BE-SMART)
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|ClinicalTrials.gov Identifier: NCT03183388|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mood Disorders||Behavioral: BE-SMART||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|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)|
|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|
Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.
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.
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT03183388
|Contact: Susan Quatrano, BA||+1 (203) email@example.com|
|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 firstname.lastname@example.org|
|Contact: Susan Quatrano 203-785-7875 email@example.com|
|Principal Investigator: Hilary Blumberg, MD|
|Sub-Investigator: Wendy Silverman, PhD|
|Principal Investigator:||Hilary P Blumberg, MD||Yale School of Medicine|