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

NCT ID: NCT03183388

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2022-06-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BE-SMART

Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.

Group Type: EXPERIMENTAL

BE-SMART

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilary P Blumberg, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Mood Disorders Research Program, Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

References

Kim JA, Sankar A, Marks R, Carrubba E, Lecza B, Quatrano S, Spencer L, Constable RT, Pittman B, Lebowitz ER, Silverman WK, Swartz HA, Blumberg HP. Chronotherapeutic intervention targeting emotion regulation brain circuitry, symptoms, and suicide risk in adolescents and young adults with bipolar disorder: a pilot randomised trial. BMJ Ment Health. 2025 Feb 19;28(1):e301338. doi: 10.1136/bmjment-2024-301338.

Reference Type: DERIVED

PMID: 39971594 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R61MH111929

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3UG3MH111929-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0407026910

Identifier Type: -

Identifier Source: org_study_id