The BEAR Therapeutic Program for Women

PTSD Clinical Trial

Official title:

The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04418778
• Other study ID #: 54562
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Jennifer Keller, PhD
• Phone: 650-723-8330
• Email: BEARstudy[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current study aims to test a novel therapeutic intervention for women who have a history of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group incorporates psychological skills, psychoeducation, and physical empowerment training, all within a therapeutic process. It will be implemented iwith women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). The investigators aim to understand how this program effects one's self-efficacy and whether the program can reduce rates mental health problems (such as depression and anxiety) and reduce the rates of revictimization. Women who participate in the BEAR group must be able to attend in-person sessions. The control group can be remote.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women ages 18-70

2. History of physical, sexual, and/or emotional abuse/neglect/violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.

Exclusion Criteria:

1. Active, significant substance abuse

2. Significant medical conditions that would preclude safe participation in the study

3. High levels of depression with significant suicide risk

4. Psychiatric instability

5. History of assaultive behavior or is judged to be at potential risk to assault others.

Related Conditions & MeSH terms

• Depression, Anxiety
• Psychological Trauma
• PTSD
• Trauma, Psychological

Intervention

Behavioral:
• BEAR
Building Empowerment and Resilience Therapy group

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Coping Self-Efficacy Scale (CSES)	The CSES is designed to measure an individual's perception of her competence to carry out coping strategies effectively when faced with a challenge or threat.	baseline to post-group (3 months)
Primary	Trauma Symptom Inventory-II (TSI-2).	The TSI-2 is a self-report measure of trauma-related symptoms and behaviors.	baseline to post-group (3 months)