Bipolar Disorder, Major Depressive Disorder, Mood Disorders, Suicidal Ideation, Suicide
Conditions
Brief summary
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.
Detailed description
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 1. Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases 2. Show pre-post BE-SMART-DR improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vPFC), (HAV), system)
Interventions
BEHAVIORALBE-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
BEHAVIORALpsychoeducational 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
Sponsors
Yale University
American Foundation for Suicide Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
16 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD) * have a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI
Exclusion criteria
* Significant medical or neurologic illness (especially if related to cerebral tissue) * MRI contraindication, * pregnancy by urine test * current moderate or severe alcohol/other substance use disorders except caffeine/nicotine * positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month * current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest (e.g. transcranial magnetic stimulation or electro-convulsive therapy), * current psychosis * inability to provide informed consent, including IQ\<70, Young Mania Rating Scale (YMRS) \>25, or too symptomatic by PI's judgment * active suicidal plan or intent or Columbia Suicide Severity Rating Scale (C-SSRS) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician. * homicidal ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) | 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. |
| Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation. | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) | 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. |
| Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS) | Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) | 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. |
| Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI) | Baseline (pre-intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHilary Blumberg, MD
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 22 |
| other Total, other adverse events | 0 / 43 | 0 / 22 |
| serious Total, serious adverse events | 0 / 43 | 0 / 22 |
Outcome results
None listed