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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mood Disorders; Bipolar Disorder; Suicidal Ideation; Suicide; Major Depressive Disorder
• Intervention / Treatment: Behavioral: BE-SMART-DR; Behavioral: psychoeducational control comparator condition (CC)

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)

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilary Blumberg, MD; Phone Number: 203-785-6180; Email: hilary.blumberg@yale.edu
• Study Contact Backup: Name: Susan Quatrano, BA; Phone Number: (203) 785-7875; Email: susan.quatrano@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Magnetic Resonance Research Center
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Mood Disorders Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Concise Health Risk Tracking Scale (CHRT)	Change from baseline in Suicidal Ideation/Propensity (SI/P) using Concise Health Risk Tracking Scale (CHRT), a brief self report measure. The CHRT Propensity score (9 items) covers the domains of pessimism, helplessness, despair and perceived lack of social support. Items are scored on a five-point Likert scale with responses ranging from "strongly disagree" (zero) to "strongly agree" (four), thereby creating a total propensity score that ranges from 0-36, with higher scores showing higher levels of suicidal propensity and suicidal thoughts.	baseline, week 1, week 7, week 12 and month 6
Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Brief Social Rhythm Scale (BSRS)	Change from baseline in BE-SMART-DRs Daily Rhythms (DR) will be assessed using the Brief Social Rhythm Scale (BSRS). This 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), with high mean scores indicating high irregularity. Summary scores are the average across all 10 items with higher scores indicating higher irregularity.	baseline, week 1, week 7, week 12 and month 6
Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI)	Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI), a self-reported survey. The 10 items in the PSQI relate to usual sleep habits over the last month, including time it takes to fall asleep, usual bedtime, hours of sleep per night, as well as questions about the frequency of sleep issues (not during the past month, less than once per week, once or twice per week, or three or more times per week). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.	baseline, week 1, week 7, week 12 and month 6
Change in the experimental group from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Beck Scale for Suicide Ideation (SSI)	Change in the experimental group from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using the interviewer assessed Beck Scale for Suicide Ideation (SSI), one of the most widely used measures to assess suicidal ideation. This is a 19 item scale with scores ranging from 0 to 38, with higher values indicating a greater risk of suicide.	baseline, week 1, week 7, week 12 and month 6
Change in the experimental group from baseline in BE-SMART-DRs Daily Rhythm (DR) using the Social Rhythm Metric (SRM)	Change in the experimental group from baseline in Daily Rhythms (DR) regularity using the Social Rhythm Metric (SRM). This is a five-item measure to assess the stability of social rhythms. Its interpretation can be qualitative and it can also be used as a therapy tool.	up to 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Foundation for Suicide Prevention
• Investigators: Principal Investigator: Hilary Blumberg, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Bipolar and Related Disorders; Self-Injurious Behavior; Depressive Disorder; Bipolar Disorder; Suicide; Suicidal Ideation; Mood Disorders; Depressive Disorder, Major
• Other Study ID Numbers: 2000032361; STR-1-002-20 (Other Grant/Funding Number: American Foundation for Suicide Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No