Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R61MH111929 | U.S. NIH Grant/Contract | View source | |
| 3UG3MH111929-02S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BE-SMART | Experimental | Psychobehavioral intervention with focus either on teaching emotional regulation skills or regularizing daily sleep and activity levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BE-SMART | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hilary P Blumberg, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mood Disorders Research Program, Yale School of Medicine | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39971594 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
76 participants were enrolled and 60 started
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BE-SMART DR | Adolescents and young adults with BD who received baseline scan and Brain Emotion Circuitry Targeted Self-Monitoring Regulation Daily Rhythms (BE-SMART DR) |
| FG001 | BE-SMART ER | Adolescents and young adults with bipolar disorder (BD) who received baseline scan and Brain Emotion Circuitry Targeted Self- Monitoring Regulation Therapy Emotion Regulation (BE-SMART ER) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BE-SMART ER | Adolescents and young adults with BD who received baseline scan and Brain Emotion Circuitry Targeted Self- Monitoring Regulation Therapy Emotion Regulation (BE-SMART ER) |
| BG001 | BE-SMART DR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | BOLD signal | baseline and 12 weeks |
up to 12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BE-SMART | The group received Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART), an intervention designed to provide improvements to the functioning of emotion brain circuitry with variations that focus on either providing skills to improve explicit emotion regulation (BE- SMART-ER) or to regularize sleep and other daily rhythms (BE-SMART-DR). Participants took part in BE-SMART, designed to be comprised of 12 therapy sessions, at a rate of about 1 session every one to two weeks. Participants were asked to complete worksheets and practice the skills learned from the sessions and asked questions about their symptoms and behaviors. There were interview assessments and scanning performed prior to providing the intervention and at the midpoint and endpoint. The intervening 9 sessions were performed by video telecommunication. Each subject received one of two BE-SMART variations both designed to target the functioning of emotion regulation brain circuitry: one with main focus on providing skills to improve explicit emotion regulation (BE- SMART-ER) and one with main focus to regularize sleep and other daily rhythms (BE-SMART-DR). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilary Blumberg | Yale School of Medicine | 203-785-6180 | hilary.blumberg@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2023 | Jul 21, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. | Baseline and 6 weeks |
| Withdrawal by Subject |
|
| Moved |
|
| Met Exclusion Criteria |
|
| COVID Pandemic Related |
|
Adolescents and young adults with BD who received baseline scan and Brain Emotion Circuitry Targeted Self-Monitoring Regulation Daily Rhythms (BE-SMART DR)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | BE-SMART DR | Adolescents and young adults with BD who received baseline and endpoint scans and BE-SMART-DR and had fMRI activation data at both timepoints of sufficient quality for analyses. |
| OG001 | BE-SMART ER | Adolescents and young adults with BD who received baseline and endpoint scans and BE-SMART-ER and had fMRI activation data at both timepoints of sufficient quality for analyses. |
|
|
|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | BOLD signal | Baseline and 6 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | Z-transformed correlation coefficient | Baseline and 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | Z-transformed correlation coefficient | Baseline and 6 weeks |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
Not provided
Not provided
Not provided