NCT03183388

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 16 Years – 29 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Mood Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-17
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2017-06-12
• Last updated: 2024-02-29
• Results posted: 2024-02-29

Locations

1 site across 1 country: United States