BEAR Program for Suicidal Thoughts

(BEAR-SI Trial)

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Substance abuse, Medical conditions, Psychiatric instability, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new form of group therapy called BEAR-SI for women who have experienced interpersonal trauma and currently have suicidal thoughts. The therapy combines skills training, education about trauma and violence, and self-defense within a supportive group setting. It aims to empower women and reduce suicidal thoughts. Women who have faced physical, sexual, or emotional abuse and struggle with suicidal thinking might be a good fit for this trial.

As an unphased trial, participants can contribute to groundbreaking research that may lead to new therapeutic approaches for women facing similar challenges.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BEAR therapy group is safe for participants?

The BEAR therapy group is a new type of group therapy designed to assist women who have experienced trauma and have suicidal thoughts. This therapy combines learning psychological skills, understanding trauma, and self-defense training. Although specific data on the safety of BEAR-SI therapy from past studies is unavailable, it is important to note that this is a therapy program, not a medication, focusing on mental and emotional support.

Therapies like BEAR-SI usually aim to empower participants and teach them skills to better manage their feelings and situations. Research on similar therapies has shown they are generally well-tolerated. This study is in a "Not Applicable" phase, focusing on assessing the program's effectiveness rather than proving safety. While this might mean less direct evidence on safety, therapy-based interventions are typically low-risk compared to drug treatments. Participants can expect a supportive environment aimed at improving mental health and self-confidence. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the BEAR-SI treatment for suicidal thoughts because it offers a novel approach through a specialized therapy intervention. Unlike standard treatments like medication and cognitive-behavioral therapy, which often focus on managing symptoms or altering thought patterns, BEAR-SI is designed to directly intervene with the underlying emotional and behavioral responses associated with suicidal ideation. This targeted method could provide a more direct and potentially faster route to relief for individuals struggling with these thoughts.

What evidence suggests that the BEAR therapy group is effective for suicidal thoughts?

Research shows that therapy can greatly reduce thoughts of suicide. Studies find that about 95.7% of people who receive therapy experience fewer suicidal thoughts. The BEAR program, offered in this trial, specifically targets women who have experienced trauma. It aims to boost their confidence in succeeding and reduce suicidal thoughts. The program includes learning psychological skills, understanding trauma, and self-defense training. While the effectiveness of the BEAR program is still under study, its components are based on methods known to help with suicidal thoughts. ^{5 6 7 8 9}

Who Is on the Research Team?

Jennifer Keller, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for women who have experienced interpersonal trauma such as physical, sexual, or emotional abuse/neglect and are currently dealing with suicidal thoughts. It's designed to help those struggling with mental health issues like depression, PTSD, anxiety, and the aftermath of sexual assault.

Inclusion Criteria

I am a woman aged between 18 and 75.

I have experienced violence and it has affected me emotionally or psychologically.

Current suicidal thinking

Exclusion Criteria

No current suicidal ideation or behaviors

Significant medical conditions that would preclude safe participation in the study

No history of interpersonal trauma

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the 12-week BEAR therapy program, which includes psychological skills, psychoeducation, and physical self-defense training

12 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for changes in self-efficacy and suicidal ideation at 3 and 12 months post-treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BEAR-SI

Trial Overview

The BEAR Program being tested offers a new form of group therapy combining psychological skills training, education about trauma and gender-based violence, along with physical self-defense techniques within a therapeutic framework.

How Is the Trial Designed?

Group I: BEAR therapy group Experimental Treatment 1 Intervention

BEAR therapy intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07346638

The BEAR Program for Women With Trauma Who Have ...

Our goal is to determine the feasibility of the adapted BEAR program and if it enhances self-efficacy and decreases suicidal thoughts. This is a ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5730496/

The Interpersonal Theory of Suicide: A Systematic Review and ...

Suicidal Thoughts and Behavior Outcomes. We extracted and analyzed outcome data on self-reported suicidal thoughts and behaviors. There were three primary ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1359178923000587

Systematic review of interventions to address suicidal ...

We conducted a systematic review of intervention studies across the globe that reported suicidal behavior outcomes among people with a history of IPV.

4.

psychiatryonline.org

psychiatryonline.org/doi/full/10.1176/appi.focus.23021003

Existing and Novel Biological Therapeutics in Suicide ...

We summarize outcomes for several pharmacologic and neurostimulatory approaches that have been considered potential treatments to reduce ...

5.

frontiersin.org

frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2019.00277/full

Effectiveness of Psychotherapy on Suicidal Risk

Results were positive overall, with a decrease of suicidal ideation rates in 95.7% of them. The most used psychotherapeutic treatments were DBT ...

6.

floridabar.org

floridabar.org/member/healthandwellnesscenter/

Mental Health and Wellness Center

The Bar's Mental Health & Wellness of Florida Lawyers Committee is working to destigmatize mental illness, recommend best practices and remedies.

7.

nimh.nih.gov

nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers

Conducting Research with Participants at Elevated Risk for ...

NIMH is encouraging mental health researchers more broadly to ask questions about suicide and suicide risk as part of their study assessments.

8.

sprc.org

sprc.org/resources/stanley-brown-safety-plan/

Stanley-Brown Safety Plan

A brief intervention to help those experiencing self-harm and suicidal thoughts with a concrete way to mitigate risk and increase safety.

9.

dph.illinois.gov

dph.illinois.gov/content/dam/soi/en/web/idph/files/publications/illinoisstrategicplan2020reduced.pdf

Illinois Suicide Prevention Strategic Plan 2020

The law took the first step by giving the Illinois. Department of Public Health responsibility for coordinating statewide suicide prevention, intervention, and ...