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

NCT05317481 | Completed Results

• 2 other identifiers: 2000032361STR-1-002-20
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

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.

Behavioral: BE-SMART-DR

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.

Behavioral: psychoeducational control comparator condition (CC)

Interventions

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

BE-SMART-DR

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

control comparator condition

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (2)

Magnetic Resonance Research Center

New Haven, Connecticut, 06510, United States

Location

Mood Disorders Research Program

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Depressive Disorder; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Hilary Blumberg, MD
• Organization: Yale University

hilary.blumberg@yale.edu

203-785-6180

Study Officials

• Hilary Blumberg, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 7, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)