Psychobehavioral Intervention for Reducing Suicide Risk

No longer recruiting at 1 trial location

Overseen By Hilary Blumberg, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Benzodiazepines, Cocaine, Amphetamines, others

Disqualifiers: Neurologic illness, Pregnancy, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called BE-SMART-DR (Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms), designed to help regulate sleep and daily routines to lower suicide risk. It provides tools for participants to manage and improve mental health independently over time. Individuals with bipolar disorder or major depressive disorder who have previously attempted suicide might be suitable candidates. Participants will attend 12 weekly sessions and have a follow-up after six months. As an unphased trial, this study offers a unique opportunity to access innovative therapy and contribute to groundbreaking mental health research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those currently receiving certain therapies like cognitive behavioral therapy or treatments targeting specific brain regions.

What prior data suggests that this psychobehavioral intervention is safe for reducing suicide risk?

Research shows that the BE-SMART-DR treatment, which helps individuals monitor and manage their emotions and daily routines, is designed to be safe and non-invasive. It does not involve medication, thus avoiding many drug-related side effects. Instead, it employs methods like interviews, wearable devices, and smartphone apps to manage emotions and behaviors.

Early results suggest that participants generally handle these methods well. Since the treatment does not involve drugs, the risk of serious side effects remains low. This approach has been used in other studies with similar goals and has shown promise in helping individuals manage their emotions without major safety concerns.

Although detailed information on side effects specific to BE-SMART-DR is not available, its focus on behavior rather than medication supports its safety. Participants can feel reassured about the minimal risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BE-SMART-DR approach because it combines technology with psychobehavioral techniques to tackle suicide risk. Unlike traditional treatments that often focus solely on therapy or medication, this method uses smartphones for real-time assessments and actigraphy wearables to monitor activity levels. The integration of MRI scans helps to understand brain changes over time. This holistic approach offers a more personalized and data-driven way to reduce suicide risk and improve mental health outcomes.

What evidence suggests that this trial's treatments could be effective for reducing suicide risk?

Research has shown that BE-SMART-DR, one of the treatments in this trial, can help individuals better manage their emotions and actions. A small initial study found this treatment feasible and well-received by participants, suggesting its potential effectiveness in everyday life. It focuses on daily routines to enhance brain function and reduce suicide risk. Another study found that similar treatments reduced mood problems and suicide risk, even when mood issues were present. This method, emphasizing regular daily habits, offers a promising approach to lowering suicide risk over time. Participants in this trial may also be assigned to the psychoeducational control comparator condition (CC), which serves as an active comparator. ^{1 2 3 6 7}

Who Is on the Research Team?

Hilary Blumberg, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young individuals with Bipolar Disorder or Major Depressive Disorder who have attempted suicide or have significant suicidal thoughts. They must be able to consent and not be pregnant, overly manic, psychotic, or under certain substance influences. Those with severe medical conditions or undergoing specific psychotherapies are excluded.

Inclusion Criteria

Patients with a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI

I have been diagnosed with Bipolar Disorder or Major Depressive Disorder.

Exclusion Criteria

Pregnancy by urine test

Homicidal ideation

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BE-SMART-DR intervention or a psychoeducational control comparator condition over 12 weekly sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including in-person follow-up and assessments

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BE-SMART-DR
• psychoeducational control comparator condition (CC)

Trial Overview The study tests BE-SMART-DR, a non-drug intervention aiming to regularize daily rhythms like sleep to reduce suicide risk in adolescents and young adults. It's compared against a psychoeducational control condition to measure effectiveness.

How Is the Trial Designed?

Group I: BE-SMART-DR Experimental Treatment 1 Intervention

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 II: control comparator condition Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Published Research Related to This Trial

In a study involving 15 adolescent suicide attempters, 15 adolescents with depression but no suicide attempts, and 14 healthy controls, it was found that the neural circuitry related to attentional and behavioral control did not show abnormal activity in suicide attempters during a response inhibition task.

The research revealed that while suicide attempters did not differ from healthy controls in brain activity during the task, they exhibited different activation patterns in the right anterior cingulate gyrus compared to adolescents with depression who had not attempted suicide, suggesting distinct neural mechanisms underlying suicidal behavior in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissociable patterns of neural activity during response inhibition in depressed adolescents with and without suicidal behavior. Pan, LA., Batezati-Alves, SC., Almeida, JR., et al.[2021]

Despite advancements in psychiatric treatment, suicide rates have increased, highlighting a gap in effective interventions targeting suicidal thoughts and behaviors.

The review emphasizes the importance of understanding the temporal nature of suicide risk and suggests integrating neurobiological insights with real-time tracking of risk to develop more effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Interventional Neuroscience to Suicide: It's About Time. Barredo, J., Bozzay, ML., Primack, JM., et al.[2023]

This review highlights the need for rapid-acting interventions in suicide crisis treatment and discusses innovative assessment methods that can track quick changes in suicidal thoughts and behaviors.

New techniques such as ecological momentary assessment and neuroimaging are being developed to improve our understanding of the psychological and biological factors related to suicide risk, potentially leading to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Methods for Assessing Rapid Changes in Suicide Risk. Ballard, ED., Gilbert, JR., Wusinich, C., et al.[2023]

This study aims to explore the brain circuits related to suicidal thoughts and behaviors (STBs) in a sample of 136 US military veterans, half of whom have STBs, using advanced neuroimaging techniques like fMRI.

By comparing brain activity and connectivity in veterans with and without STBs, the research seeks to identify how these brain circuits influence decision-making and impulsivity, potentially leading to better understanding and treatment of STBs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidal thoughts and behaviours among military veterans: protocol for a prospective, observational, neuroimaging study. Namaky, N., Swearingen, HR., Winter, J., et al.[2023]

A study involving 75 adults used magnetoencephalography (MEG) to identify neural correlates of suicide risk, revealing that those at the highest risk had stronger implicit associations with death and distinct gamma power patterns in specific brain regions.

In a pilot study of five high-risk participants, ketamine administration increased gamma power related to self-death associations in the left insula, suggesting that pharmacotherapies targeting gamma activity may help reduce suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical, behavioral, and electrophysiological profiles along a continuum of suicide risk: evidence from an implicit association task. Lamontagne, SJ., Gilbert, JR., Zabala, PK., et al.[2023]

Suicide is a major public health issue, with nearly a million deaths globally each year, and is linked to complex interactions of biological, psychological, and sociocultural factors.

The paper suggests using machine learning to combine neurobiological data with mood dysregulation symptoms to better understand the inflammatory processes that may increase suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating biobehavioral information to predict mood disorder suicide risk. Jackson, NA., Jabbi, MM.[2022]

A study involving 78 young adults (ages 18-25) identified key factors associated with suicidal thoughts and behaviors, including age, education level, depression, psychiatric distress, and left amygdala activity during emotional processing.

The left amygdala's activity was found to be a significant neurobiological marker for predicting suicidal thoughts and behaviors, suggesting that neuroimaging could play a crucial role in understanding and addressing suicide risk in young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the study of suicidal thoughts and behaviors in distressed young adults: The use of a machine learning approach to identify neuroimaging, psychiatric, behavioral, and demographic correlates. Oppenheimer, CW., Bertocci, M., Greenberg, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11840897/

Chronotherapeutic intervention targeting emotion regulation ... This pilot randomised trial aimed to assess the feasibility, acceptability, and preliminary efficacy of BE-SMART-DR and BE-SMART-ER in ...

2. reporter.nih.gov reporter.nih.gov/project-details/9372707

Project Details - NIH RePORTER This study tests a promising novel psychobehavioral intervention, Brain Emotion Self-Monitoring and Regulation Therapy (BE- SMART), that is based on advances in ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/88/NCT03183388/Prot_SAP_000.pdf

Title: Brain Emotion Circuitry-Targeted Self-Monitoring and ... This collected information will demonstrate that the treatment can help subjects to better self-regulate their emotional responses and behaviors ...

4. afsp.org afsp.org/grant/reducing-suicide-risk-in-adolescents-and-young-adults-via-a-psychobehavioral

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

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.psychotherapy.20210011

Telehealth Social Rhythm Therapy to Reduce Mood ... The intervention appeared to reduce mood symptoms, and suicide propensity independent of mood symptoms, among adolescents and young adults with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05317481

Reducing Suicide Risk in Adolescents and Young Adults ... The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield ...

7. mentalhealth.bmj.com mentalhealth.bmj.com/content/28/1/e301338.info

Chronotherapeutic intervention targeting emotion ... This is the first study to evaluate the effects of Brain Emotion Circuitry-targeted Self-Monitoring and Regulation Therapy for Daily Rhythms (BE ...