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Recruiting NCT07346638

The BEAR Program for Women With Trauma Who Have Suicidal Thoughts

No phase Interventional Interpersonal Trauma Depression PTSD Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BEAR-SI.
Who it may be relevant to
Registry conditions: Interpersonal Trauma, Depression, PTSD, Anxiety. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study of the Building Empowerment and Resilience Program for Suicidal Ideation

Overview

The current study aims to test the feasibility of a new form of group therapy for women who have a history of interpersonal trauma and current suicidal ideation. The Building Empowerment and Resilience (BEAR) Therapeutic group has been adapted for women who have experienced trauma and have current suicidal ideation. It incorporates psychological skills, psychoeducation about trauma and gender-based violence, and physical self-defense training, all within a therapeutic process. It will be implemented with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect) and experience various mental health difficulties, including suicidal ideation. We aim to assess the feasibility to recruit and implement the BEAR group. Our ultimate aim is to assess whether the program can effect self-efficacy and suicidal ideation.

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.

Interventions

  • Behavioral BEAR-SI
    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 commu

Primary outcome measures

  • Coping self-efficacy [Time frame: Baseline to 12 weeks (post-group)]
  • Beck Scale for Suicidal Ideation [Time frame: Baseline to 12 weeks (post-group)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University School of Medicine — Stanford

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. PMID 29624123
  • 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. PMID 18456241
  • 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. PMID 32202845

Identifiers

NCT: NCT07346638 · 79226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗