The BEAR Therapeutic Program for Women

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04418778
Collaborator
(none)
120
1
38
3.2

Study Details

Study Description

Brief 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 at several different sites, with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). We 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BEAR

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
BEAR intervention group

BEAR Therapeutic group for women who have experienced interpersonal trauma

Behavioral: BEAR
Building Empowerment and Resilience Therapy group

BEAR LifeMoves intervention group

BEAR Therapeutic group for women who have experienced interpersonal trauma who are currently living in transitional housing at LifeMoves

Behavioral: BEAR
Building Empowerment and Resilience Therapy group

Control Condition

Treatment as usual group, women participating in individual or group therapy but not taking the BEAR group

Outcome Measures

Primary Outcome Measures

  1. Change in Coping Self-Efficacy Scale (CSES) [baseline to post-group (3 months)]

    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.

  2. Trauma Symptom Inventory-II (TSI-2). [baseline to post-group (3 months)]

    The TSI-2 is a self-report measure of trauma-related symptoms and behaviors.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Keller, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT04418778
Other Study ID Numbers:
  • 54562
First Posted:
Jun 5, 2020
Last Update Posted:
Mar 19, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer Keller, Clinical Associate Professor, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2021