Trauma, PsychologicalNCT04418778
The BEAR Therapeutic Program for Women
An observational study of Trauma, Psychological and Depression, Anxiety, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Trauma, Psychological, Depression, Anxiety, PTSD
- What is being tested?
- BEAR
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have experienced interpersonal violence broadly defined
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: 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 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.
- Conditions
- Trauma, Psychological, Depression, Anxiety, PTSD
- Being tested
- BEAR
- Keywords
- empowerment, therapeutic intervention
- Medical subject headings
- Psychological Trauma, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEARBehavioural
Building Empowerment and Resilience Therapy group
| Study group | Role | What they receive |
|---|---|---|
| BEAR intervention group | BEAR Therapeutic group for women who have experienced interpersonal trauma Receives: Behavioral: BEAR | |
| Control Condition | Treatment as usual group, women participating in individual or group therapy but not taking the BEAR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to post-group (3 months)
Trauma Symptom Inventory-II (TSI-2).
The TSI-2 is a self-report measure of trauma-related symptoms and behaviors.
Measured: baseline to post-group (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Mar 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Keller, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418778
- Sponsor's protocol ID
- 54562
- Status last verified
- Feb 2025
- First submitted
- 29 May 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma
- ClinicalTrials.gov ID
- NCT04418778
- Acronym / sponsor ID
- 54562
- Conditions
- Trauma, Psychological, Depression, Anxiety, PTSD
- Keywords
- empowerment, therapeutic intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEAR intervention group | – | Behavioral: BEARBEAR Therapeutic group for women who have experienced interpersonal trauma |
| Control Condition | – | –Treatment as usual group, women participating in individual or group therapy but not taking the BEAR group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have experienced interpersonal violence broadly defined
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEARBuilding Empowerment and Resilience Therapy group | Behavioural | BEAR intervention group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Psychological and Depression, Anxiety, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Coping Self-Efficacy Scale (CSES) (time frame: baseline to post-group (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.