- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04418778
The BEAR Therapeutic Program for Women
March 18, 2021 updated by: Jennifer Keller, Stanford University
The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Keller, PHD
- Phone Number: 650-723-8330
- Email: jkeller@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
Contact:
- Jennifer Keller, PHD
- Phone Number: 650-723-8330
- Email: jkeller@stanford.edu
-
Contact:
- Maureen Chang, B.S.
- Phone Number: (650) 723-8330
- Email: maureen.chang@stanford.edu
-
Principal Investigator:
- Jennifer Keller
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women who have experienced interpersonal violence broadly defined
Description
Inclusion Criteria:
- Women ages 18-70
- 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:
- Active, significant substance abuse
- Significant medical conditions that would preclude safe participation in the study
- High levels of depression with significant suicide risk
- Psychiatric instability
- History of assaultive behavior or is judged to be at potential risk to assault others.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
BEAR intervention group
BEAR Therapeutic group for women who have experienced interpersonal trauma
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Coping Self-Efficacy Scale (CSES)
Time Frame: 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.
|
baseline to post-group (3 months)
|
Trauma Symptom Inventory-II (TSI-2).
Time Frame: baseline to post-group (3 months)
|
The TSI-2 is a self-report measure of trauma-related symptoms and behaviors.
|
baseline to post-group (3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
May 29, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (Actual)
June 5, 2020
Study Record Updates
Last Update Posted (Actual)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 18, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54562
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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