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

NCT03183388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-02-29

Study results available
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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.

Conditions

  • Mood Disorders

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Hilary P Blumberg, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183388 on ClinicalTrials.gov