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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317481
• Other study ID #: 2000032361
• Secondary ID: STR-1-002-20
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Hilary Blumberg, MD
• Phone: 203-785-6180
• Email: hilary.blumberg[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Magnetic Resonance Research Center	New Haven	Connecticut
United States	Mood Disorders Research Program	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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