Mood DisordersBE-SMARTNCT03183388

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

A study testing BE-SMART in people with Mood Disorders, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 to 29 years
Conditions the study is for: Mood Disorders
What is being tested?: BE-SMART
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2017to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 29 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mood Disorders Research Program, Yale School of Medicine
New Haven, Connecticut, 06511

Other trials in United States

About this study

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.

Read the 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
Being tested: BE-SMART
Keywords: psychotherapy
Medical subject headings: Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BE-SMARTBehavioural
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.

Study groups in NCT03183388
Study group	Role	What they receive
BE-SMART	Experimental	Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels. Receives: Behavioral: BE-SMART

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention
FMRI was performed during an emotional face processing task. Signal differences (BOLD changes) were compared between baseline and endpoint, separately for BE-SMART-DR or BE-SMART-ER, at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If voxels above this threshold survived in a hypothesized region of interest (amygdala and ventral prefrontal cortex, VPFC) then the signal differences in those voxels were extracted and mean values within the region for each subject were used in the analyses below. The only voxel-based finding meeting criteria was left amygdala activation decreases to fearful faces in participants receiving BE-SMART-DR. The results of the mixed model analysis of those values are below.
Measured: baseline and 12 weeks
FMRI BOLD Signal Changes in Left Amygdala at Baseline and Midpoint
Signal differences (BOLD changes) between baseline and midpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI activation analyses. The results of the mixed model analyses of those values are below.
Measured: Baseline and 6 weeks
fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Endpoint
Pearson's correlations between the mean timecourse of the seed and the timecourse of each voxel between baseline and endpoint were compared at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If there were voxels above this threshold in the hypothesized region of interest (ventral prefrontal cortex), then the correlation values from those voxels in that region were extracted and Fisher transformed and averaged, where higher scores indicted greater connectivity. Functional connectivity differences between baseline and endpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI functional connectivity analyses. The results of the mixed model analysis of those values are below.
Measured: Baseline and 12 weeks
fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Midpoint
Pearson's correlations between the mean timecourse of the seed and the timecourse of each voxel between baseline and midpoint were compared at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If there were voxels above this threshold in the hypothesized region of interest (ventral prefrontal cortex), then the correlation values from those voxels in that region were extracted and Fisher transformed and averaged where higher scores indicte greater connectivity. Functional connectivity differences between baseline and midpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI functional connectivity analyses. The results of the mixed model analysis of those values are below.
Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201730 Jun 2022

First posted12 Jun 2017
Study start17 Oct 2017
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mood DisordersStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03183388
Sponsor's protocol ID: 0407026910
Other IDs: R61MH111929, 3UG3MH111929-02S1
Acronym: BE-SMART
Status last verified: Feb 2024
First submitted: 8 Jun 2017
Last updated: 29 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39971594

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder

All Mood Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
ClinicalTrials.gov ID: NCT03183388
Acronym / sponsor ID: BE-SMART / 0407026910
Conditions: Mood Disorders
Keywords: psychotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 17 Oct 2017 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 12 Jun 2017 (actual)
Results: Posted 29 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Hypothesis : The emotional regulation psychotherapy treatment will be associated with changes in emotional regulation circuitry.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
BE-SMART	Experimental	Behavioral: BE-SMARTPsychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels.

Who may qualify

Ages: 16 to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BE-SMARTParticipants 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.	Behavioural	BE-SMART

Primary outcome

Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention
Time frame: baseline and 12 weeks
FMRI was performed during an emotional face processing task. Signal differences (BOLD changes) were compared between baseline and endpoint, separately for BE-SMART-DR or BE-SMART-ER, at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If voxels above this threshold survived in a hypothesized region of interest (amygdala and ventral prefrontal cortex, VPFC) then the signal differences in those voxels were extracted and mean values within the region for each subject were used in the analyses below. The only voxel-based finding meeting criteria was left amygdala activation decreases to fearful faces in participants receiving BE-SMART-DR. The results of the mixed model analysis of those values are below.
FMRI BOLD Signal Changes in Left Amygdala at Baseline and Midpoint
Time frame: Baseline and 6 weeks
Signal differences (BOLD changes) between baseline and midpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI activation analyses. The results of the mixed model analyses of those values are below.
fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Endpoint
Time frame: Baseline and 12 weeks
Pearson's correlations between the mean timecourse of the seed and the timecourse of each voxel between baseline and endpoint were compared at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If there were voxels above this threshold in the hypothesized region of interest (ventral prefrontal cortex), then the correlation values from those voxels in that region were extracted and Fisher transformed and averaged, where higher scores indicted greater connectivity. Functional connectivity differences between baseline and endpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI functional connectivity analyses. The results of the mixed model analysis of those values are below.
fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Midpoint
Time frame: Baseline and 6 weeks
Pearson's correlations between the mean timecourse of the seed and the timecourse of each voxel between baseline and midpoint were compared at a voxel-level threshold of p<0.001 uncorrected using statistical parametric mapping (SPM) software. If there were voxels above this threshold in the hypothesized region of interest (ventral prefrontal cortex), then the correlation values from those voxels in that region were extracted and Fisher transformed and averaged where higher scores indicte greater connectivity. Functional connectivity differences between baseline and midpoint in regions of interest that survived the voxel-based threshold in participants who received either BE-SMART variation and had fMRI data of sufficient quality for fMRI functional connectivity analyses. The results of the mixed model analysis of those values are below.

Results and safety

Results posted to the registry on 29 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BE-SMART DR	30	17
BE-SMART ER	30	14

Primary outcome: Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention

Time frame: baseline and 12 weeks. Least squares mean (Standard Error). Unit: BOLD signal

Measure	BE-SMART DR n = 11	BE-SMART ER n = 0
Baseline	1.62 (0.64)	–
12 weeks	-1.42 (0.64)	–

BE-SMART DR: Endpoint minus Baseline: -3.04 (95% CI -4.14 to -1.93), p = 0.0001, t-test, 2 sided

Population analysed: Adolescents and young adults with bipolar disorder (BD) who received intervention and had both baseline and endpoint fMRI data of sufficient quality were analyzed. Voxel-level threshold for BE-SMART-ER did not reach p\<0.001 uncorrected threshold and therefore there were no extracted values for further analyses.

Primary outcome: FMRI BOLD Signal Changes in Left Amygdala at Baseline and Midpoint

Time frame: Baseline and 6 weeks. Least squares mean (Standard Error). Unit: BOLD signal

Measure	BE-SMART-DR n = 11	BE-SMART-ER n = 0
Baseline	1.42 (0.75)	–
6 weeks	0.053 (1.93)	–

BE-SMART-DR: Midpoint minus Baseline: -1.37 (95% CI -6.97 to 4.23), p = 0.60, t-test, 2 sided

Population analysed: Adolescents and young adults with BD who received BE-SMART-DR and who had fMRI data at both at baseline and midpoint. Voxel-level threshold for BE-SMART-ER did not reach the p\<0.001 uncorrected threshold and therefore there were no extracted values for further analyses.

Primary outcome: fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Endpoint

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: Z-transformed correlation coefficient

Measure	BE-SMART DR n = 11	BE-SMART ER n = 0
Baseline	-0.057 (0.017)	–
12 weeks	0.052 (0.017)	–

BE-SMART DR: Endpoint minus Baseline: 0.11 (95% CI 0.074 to 0.146), p = 0.0001, t-test, 2 sided

Population analysed: Only adolescents and young adults with BD who had baseline and endpoint fMRI functional connectivity data of sufficient quality were analyzed. Voxel-level threshold for BE-SMART-ER did not reach the p\<0.001 uncorrected threshold and therefore there were no extracted values for further analyses.

Primary outcome: fMRI Functional Connectivity Changes in VPFC From an Amygdala Seed Region at Baseline and Midpoint

Time frame: Baseline and 6 weeks. Least squares mean (Standard Error). Unit: Z-transformed correlation coefficient

Measure	BE-SMART-DR n = 9	BE-SMART-ER n = 0
Baseline	-0.038 (0.026)	–
6 weeks	-0.0068 (0.046)	–

BE-SMART-DR: Midpoint minus Baseline: 0.031 (95% CI -0.095 to 0.157), p = 0.58, t-test, 2 sided

Population analysed: Adolescents and young adults with BD who received BE-SMART-DR with fMRI functional connectivity data at both baseline and midpoint. Voxel-level threshold for BE-SMART-ER did not reach the p\<0.001 uncorrected threshold and therefore there were no extracted values for further analyses.

Adverse events

Time frame: up to 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BE-SMART	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39971594Kim 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.
Individual participant dataSharing planned: No

Related trials for Mood Disorders

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hilary P Blumberg, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BE-SMART in people with Mood Disorders, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention (time frame: baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03183388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.