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

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05317481

Collaborator

American Foundation for Suicide Prevention (Other)

128

Enrollment

Locations

Arms

31.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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), a modification of Social Rhythm Therapy (SRT) 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Major Depressive Disorder Mood Disorders Suicide Suicidal Ideation	Behavioral: BE-SMART-DR Behavioral: psychoeducational control comparator condition (CC)	N/A

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 with a research therapist with the first, middle and last sessions in person, remaining sessions offered by secure video or audio telecommunication and 6-month in person follow-up.

Objectives

Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases
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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 2, 2022

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

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 with a research therapist with the first, middle and last sessions in person, remaining sessions offered by secure video or audio telecommunication and 6-month in person follow-up.	Behavioral: BE-SMART-DR a modification of Social Rhythm Therapy (SRT) 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	Behavioral: psychoeducational control comparator condition (CC) Structured sessions, matched for BE-SMART-DR session number and therapist time, that will emphasize strategies to manage the stress of a mental disorder and stigma, and health and wellness, offering tips on well-established self-help strategies such as a healthy diet, regular moderate exercise and seeking social support when distressed.

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 with a research therapist with the first, middle and last sessions in person, remaining sessions offered by secure video or audio telecommunication and 6-month in person follow-up.

Behavioral: BE-SMART-DR

a modification of Social Rhythm Therapy (SRT) 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

Behavioral: psychoeducational control comparator condition (CC)

Structured sessions, matched for BE-SMART-DR session number and therapist time, that will emphasize strategies to manage the stress of a mental disorder and stigma, and health and wellness, offering tips on well-established self-help strategies such as a healthy diet, regular moderate exercise and seeking social support when distressed.

Outcome Measures

Primary Outcome Measures

Change from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Beck Scale for Suicide Ideation (SSI) [baseline, week 1, week 7, week 12 and month 6]
Change 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.
Change from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Concise Health Risk Tracking Scale (CHRT) [baseline, week 1, week 7, week 12 and month 6]
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.
Change from baseline in BE-SMART-DRs Daily Rhythm (DR) using the Social Rhythm Metric (SRM) [up to 6 months]
Change 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.
Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Brief Social Rhythm Scale (BSRS) [baseline, week 1, week 7, week 12 and month 6]
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.
Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI) [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), 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 29 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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