- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346638
The BEAR Program for Women With Trauma Who Have Suicidal Thoughts (BEAR-SI)
A Pilot Study of the Building Empowerment and Resilience Program for Suicidal Ideation
Study Overview
Status
Intervention / Treatment
Detailed Description
In the US, approximately 36% of women experience some type of sexual violence in their lifetime. Sexual violence can have a significant and lifelong impact on a women's life, with particularly high rates of mental health issues (e.g., depression, anxiety, PTSD). Women who are sexually assaulted have a three-fold risk of lifetime suicidal ideation and more than a five-fold elevated risk of suicide attempts compared to women who have not been sexually assaulted. Women who are victimized are at higher risk of subsequent sexual victimizations, and with that, worsened well-being and an even higher suicide risk.
Empowerment self-defense (ESD) training has consistently been shown to reduce the risk of both attempted and completed sexual assault by approximately 50%. Survivors of rape who participate in such training demonstrate decreases in PTSD symptoms and self-blame for past assaults. Increases in perceived self-efficacy is one of the positive outcomes of ESD work. Perceived self-efficacy is one's beliefs about their competency and capabilities to perform and is a key factor of how people think, behave, feel, and motivate themselves and how they respond in various situations, including risky or traumatic situations. Higher coping self-efficacy buffers individuals who experience trauma from posttraumatic distress, and separately, higher self-efficacy has been shown to be a protective factor against suicidality in several populations.
The purpose of the current study is to test the feasibility of the Building Empowerment and Resilience (BEAR) program which was adapted for women who have a history of sexual violence and currently endorse suicidal thinking. The Building Empowerment and Resilience-SI (BEAR-SI) Therapeutic program incorporates psychological skills, psychoeducation, and physical self-defense training, all within a therapeutic process. Our experience indicates survivors of sexual violence seek a more active intervention as they often continue to feel quite vulnerable with therapy alone. The program specifically addresses the sequalae of sexual assault and teaches skills for maintaining personal safety and for coping with unwanted thoughts, including suicidal thinking. 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 12-week, in-person therapy group. We will examine pre- and post-group outcomes, as well as 3- and 12-month follow up.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Research Coordinator
- Phone Number: 650-724-7184
- Email: bearstudy@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University School of Medicine
-
Contact:
- Clinical Research Coordinator
- Phone Number: 650-724-7184
- Email: bearstudy@stanford.edu
-
Principal Investigator:
- Jennifer Keller, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women ages 18-75
- History of physical, sexual, and/or sexual emotional violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.
- Current suicidal thinking
Exclusion Criteria:
- Active, significant substance abuse, which could interfere with participation
- Significant medical conditions that would preclude safe participation in the study
- No history of interpersonal trauma
- Acute psychiatric instability
- History of assaultive behavior or is judged to be a potential risk to assault others.
- No current suicidal ideation or behaviors
- Unable to commit to the group for 12 weeks in-person
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BEAR therapy group
BEAR therapy intervention
|
The BEAR Therapeutic program is a twelve-week group that meets once per week for 1.5 hours per week.
The program includes three main components.
The first is a psycho-educational component which provides current information about assault statistics, common risk factors, myths that are often associated assault, and safety related information The second component focuses on the development of an assortment of interpersonal skills.
This part of the group offers skills such as assertiveness or communication training, boundary setting, and coping skills.
The third component of our intervention consists of a thorough set of self-defense skills that help women to keep themselves safe.
The repertoire of skills include recognizing unsafe situations, utilizing one's voice, and release from holds.
This section provides ample practice blocks, resistance skills, and specific techniques to keep one's self safe.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping self-efficacy
Time Frame: Baseline to 12 weeks (post-group)
|
This scale ranges from 0-286, with 0 indicating no confidence in managing stressors to 286 indicating very high level of confidence that one could do a particular behavior
|
Baseline to 12 weeks (post-group)
|
|
Beck Scale for Suicidal Ideation
Time Frame: Baseline to 12 weeks (post-group)
|
Assesses amount of suicidal thinking.
The total BSS score can range from 0, with no suicidal thinking to 38 points, severe level of suicidal thinking.
|
Baseline to 12 weeks (post-group)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention in the group
Time Frame: 12 weeks (post-group)
|
Will examine number of participants who completed at least 10/12 sessions
|
12 weeks (post-group)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Keller, PhD, Stanford University
Publications and helpful links
General Publications
- Hollander, J. A., & Cunningham, J. (2020). Empowerment Self-Defense Training in a Community Population. Psychology of Women Quarterly, 44(2), 187-202. https://doi-org.laneproxy.stanford.edu/10.1177/0361684319897937
- Smith, S.G., et al. (2017). The National Intimate Partner and Sexual Violence Survey (NISVS): 2010-2012 State Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention.
- Denneson LM, Smolenski DJ, Bauer BW, Dobscha SK, Bush NE. The Mediating Role of Coping Self-Efficacy in Hope Box Use and Suicidal Ideation Severity. Arch Suicide Res. 2019 Apr-Jun;23(2):234-246. doi: 10.1080/13811118.2018.1456383. Epub 2018 Jul 11.
- Cieslak R, Benight CC, Caden Lehman V. Coping self-efficacy mediates the effects of negative cognitions on posttraumatic distress. Behav Res Ther. 2008 Jul;46(7):788-98. doi: 10.1016/j.brat.2008.03.007. Epub 2008 Mar 18.
- Dworkin ER, DeCou CR, Fitzpatrick S. Associations between sexual assault and suicidal thoughts and behavior: A meta-analysis. Psychol Trauma. 2022 Oct;14(7):1208-1211. doi: 10.1037/tra0000570. Epub 2020 Mar 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 79226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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