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| ID | Type | Description | Link |
|---|---|---|---|
| STR-1-002-20 | Other Grant/Funding Number | American Foundation for Suicide Prevention |
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| Name | Class |
|---|---|
| American Foundation for Suicide Prevention | OTHER |
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The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk.
This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC). Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BE-SMART-DR | Experimental | Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. |
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| control comparator condition | Active Comparator | Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BE-SMART-DR | Behavioral | Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity | CHRT-SR is a validated, self-reported measure with a propensity subscore (9 items) identifying risk factors. Each item is scored on a five-point Likert scale with responses ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"), thereby creating a total propensity score ranging from 0-36,with higher scores showing higher levels of suicidal propensity. | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
| Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation. | Beck SSI is one of the most widely used measures to assess suicidal ideation. This nineteen item scale has scores ranging from 0 to 38, with higher values indicating a greater risk of suicide. | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
| Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS) | BSRS is a measure of DR regularity for 10 activities that include social contexts. It uses a scale ranging from 1 (very regularly) to 6 (very irregularly). Total scores range from 10 to 60, with higher scores indicating greater irregularity. | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
| Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI) | PSQI is a self reported questionnaire that assesses sleep quality over a 1 month period. It consists of seven component scores with each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21) with higher scores indicating worse sleep quality. | Baseline (pre-intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary Blumberg, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magnetic Resonance Research Center | New Haven | Connecticut | 06510 | United States | ||
| Mood Disorders Research Program |
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| ID | Title | Description |
|---|---|---|
| FG000 | BE-SMART-DR | Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Sep 24, 2024 |
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This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC).
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| psychoeducational control comparator condition (CC) | Behavioral | Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being |
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| FG001 | Control Comparator Condition | Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BE-SMART-DR | Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk |
| BG001 | Control Comparator Condition | Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity | CHRT-SR is a validated, self-reported measure with a propensity subscore (9 items) identifying risk factors. Each item is scored on a five-point Likert scale with responses ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"), thereby creating a total propensity score ranging from 0-36,with higher scores showing higher levels of suicidal propensity. | Adolescents and young adults with MDD or BD, at risk of suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the CHRT-SR at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
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| Primary | Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation. | Beck SSI is one of the most widely used measures to assess suicidal ideation. This nineteen item scale has scores ranging from 0 to 38, with higher values indicating a greater risk of suicide. | Adolescents and young adults with MDD or BD, at risk of suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the Beck SSI at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
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| Primary | Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS) | BSRS is a measure of DR regularity for 10 activities that include social contexts. It uses a scale ranging from 1 (very regularly) to 6 (very irregularly). Total scores range from 10 to 60, with higher scores indicating greater irregularity. | Adolescents and young adults with MDD or BD, at risk for suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the BSRS at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
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| Primary | Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI) | PSQI is a self reported questionnaire that assesses sleep quality over a 1 month period. It consists of seven component scores with each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21) with higher scores indicating worse sleep quality. | Adolescents and young adults with MDD or BD, at risk for suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the PSQI at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (pre-intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) |
|
6 months
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| 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-DR | Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk | 0 | 43 | 0 | 43 | 0 | 43 |
| EG001 | Control Comparator Condition | Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being | 0 | 22 | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilary Blumberg, MD | Yale University | 203-785-6180 | hilary.blumberg@yale.edu |
| Mar 31, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| D013405 | Suicide |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 12 weeks |
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within-group time effect |
| Mixed Models Analysis |
| 0.0985 |
| F statistic |
| 2.38 |
Overall F test of the within-group effect of time in the Control group from the mixed model. |
| Other |
Same model as Active group, restricted to Control participants. |
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Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
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