Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms

NCT ID: NCT05317481

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-03-31

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)

Conditions

Bipolar Disorder; Major Depressive Disorder; Mood Disorders; Suicide; Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

BE-SMART-DR

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

psychoeducational control comparator condition (CC)

Intervention Type: BEHAVIORAL

Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Foundation for Suicide Prevention

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilary Blumberg, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Magnetic Resonance Research Center

New Haven, Connecticut, United States

Mood Disorders Research Program

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

STR-1-002-20

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000032361

Identifier Type: -

Identifier Source: org_study_id