Clinical trial NCT05317481: Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Official title: Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms and Improve Brain Circuitry Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Major Depressive Disorder
Mood Disorders
Suicide
Suicidal Ideation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2022-04-07
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in the experimental group from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Beck Scale for Suicide Ideation (SSI) and Concise Health Risk Tracking Scale (CHRT)
timeFrame: baseline, during the intervention, immediately after the intervention
measure: Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Brief Social Rhythm Scale (BSRS)
timeFrame: baseline, during the intervention, immediately after the intervention
measure: Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, during the intervention, immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Magnetic Resonance Research Center
state: Connecticut
city: New Haven
country: United States
facility: Mood Disorders Research Program
state: Connecticut
Study officials:
affiliation: Yale University
name: Hilary Blumberg, MD
role: PRINCIPAL_INVESTIGATOR
References: