Life StressRBSTENCT05422638
Race-Based Stress Trauma and Empowerment
A study testing RBSTE and PCT in people with Life Stress and Racism, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The existence of racially/ethnically based health disparities is well established, both within the civilian community and among Service Members and Veterans. Experiences of discrimination are acute and chronic stressors that substantially contribute to greater emotional distress, poorer health behavior, lower… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Life Stress, Racism
- What is being tested?
- RBSTE and PCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identified as a BIPOC
- Veteran
- able to consent to study activities
- endorsing one or more perceived discrimination experiences on the Everyday Discrimination Form (short version) or the Major Experiences of Discrimination Scale (abbreviated version) "a few times a year" or more frequently and endorsing stress on a validated single-item measure
Who cannot join
- serious mental illness, alcohol/substance use disorders, or cognitive impairment that may interfere with the ability to benefit from group
- (e.g., severe depression, psychotic illness, mania, dementia, untreated alcohol/substance dependence)
- serious suicidality or homicidality (e.g., ideation with plan/intent) that is likely to require urgent/emergent intervention within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: Fostering Resilience to Race-Based Stress: A Pilot Study
The existence of racially/ethnically based health disparities is well established, both within the civilian community and among Service Members and Veterans. Experiences of discrimination are acute and chronic stressors that substantially contribute to greater emotional distress, poorer health behavior, lower healthcare utilization and increased allostatic load, all of which undermine well-being, functioning and Whole Health. An innovative clinical program, the Race-Based Stress/Trauma and Empowerment (RBSTE) group, was developed to help Veterans of Color to build coping resources and empowerment. Although qualitative data suggest the promise of this intervention, systematic evaluation is lacking. The proposed feasibility project will lay the groundwork for a future randomized controlled trial to evaluate RBSTE as compared to a control group in terms of Whole Health, functioning and mental/physical wellness. The project thus begins a program of research to address the health implications of systemic racism.
Read the detailed description
Health disparities between White and Black, Indigenous and People of Color (BIPOC) are well documented in the United States; this phenomenon is driven in part by discrimination experiences and is an important contributor to well-being and functioning, including among military service members and Veterans. The chronic stress of racism has both psychological and physiological effects. Discrimination is associated with increased psychological distress, including higher rates of PTSD among Veterans of Color (VOC), poorer health behavior and decreased healthcare utilization. Race-based stress is also linked to increased allostatic load (AL), which is a measurable index of wear-and-tear on the body due to chronic stress exposure that is associated with greater disease burden and mortality. Recognizing the unmet need for interventions to help VOC process and cope with experiences of discrimination, the Race-based Stress/Trauma and Empowerment (RBSTE) intervention (Carlson, Endsley, Motley, Shawahin, \& Williams, 2018) was developed. RBSTE is a group-based approach that combines cultural adaptations of established psychotherapeutic techniques with novel strategies to foster resilience and empowerment for VOC. Initial qualitative data suggests the promise of this approach, but no systematic data are yet available to determine whether or not RBSTE is achieving its goals of enhancing coping and restoring well-being. The proposed project is a pilot randomized controlled trial (RCT) with multi-modal longitudinal assessment. Participants will be recruited from VA facilities and the surrounding community. VOC who report race-based stress, with minimal exclusions, will be evaluated at baseline, randomized in groups to one of two wellness interventions and then re-evaluated immediately after treatment. The interventions include RBSTE and Present Centered Therapy (PCT), designed to control for nonspecific aspects of RBSTE, including support and participation in an all-BIPOC group. The interventions will be delivered in 8 weekly 90-minute group sessions by a trained mental health professional using videoconferencing. The aims of the project are (1) to assess the feasibility of recruiting VOC for an RCT of this nature; (2) to examine the acceptability and appropriateness of intervention content, the feasibility of participation, and participant's perceptions of provider behavior and attitudes; and (3) to establish the optimal strategy for quantifying mental and physical health outcomes for future studies. Thus, the project will set the stage for evaluation of RBSTE's efficacy and ultimately implementation. This critically important program of research will provide guidance as to best practices for the management of race-based stress, with the ultimate goal of eliminating health disparities for Veterans and the community more broadly.
- Conditions
- Life Stress, Racism
- Being tested
- RBSTE, PCT
- Keywords
- Life stress, Racism, Health promotion, Randomized controlled trial
- Medical subject headings
- Stress, Psychological, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBSTEBehavioural
8-week health promotion group focused on supporting coping with racism and empowerment
PCTBehavioural
Also called Present Centered Therapy
8-week health promotion group focused on providing support and facilitating problem solving
| Study group | Role | What they receive |
|---|---|---|
| RBSTE | Experimental | 8-week health promotion group focused on supporting coping with racism and empowerment Receives: Behavioral: RBSTE |
| PCT | Active comparator | 8-week health promotion group focused on providing support and facilitating problem solving Receives: Behavioral: PCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Percentage of individuals enrolled out of total contacted
Measured: week 0
Initiation Rate
Percentage of subjects who initiate any intervention among all enrolled subjects
Measured: week 1
Per Protocol Completion
Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Measured: week 8
Intent-to-treat Completion
Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Measured: week 8
Acceptability of Intervention Measure (AIM)
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Measured: week 8
Intervention Appropriateness Measure (IAM)
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Measured: week 8
Feasibility of Intervention Measure (FIM)
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Measured: week 8
Secondary outcomes (3)
Brief Personal Health Inventory (B-PHI): Physical Health
self-appraisal of physical well being range 1-5 with higher scores indicating better health
Measured: change from week 1 to week 8
Brief Personal Health Inventory (B-PHI): Mental Health
self-appraisal of mental well being range 1-5 with higher scores indicating better mental health
Measured: change from week 1 to week 8
Brief Personal Health Inventory (B-PHI): Daily Living
self-appraisal of daily living range 1-5 with higher scores indicating better daily living
Measured: change from week 1 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start2 Jan 2023
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Life StressStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RBSTE is a group-based approach that combines cultural adaptations of established psychotherapeutic techniques with novel strategies to foster resilience and empowerment for VOC. PCT is a group-based approach that provides a safe space for VOC to discuss stressors and find adaptive of responding to them.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ariel J. Lang, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422638
- Sponsor's protocol ID
- D4070-P
- Other IDs
- 1I21RX004070-01A1
- Acronym
- RBSTE
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2022
- Last updated
- 29 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang C, Malaktaris A, McLean CL, Kelsven S, Chu GM, Ross KS, Endsley M Jr, Minassian A, Liu L, Hong S, Lang AJ. Mitigating the health effects of systemic racism: Evaluation of the Race-Based Stress and Trauma Empowerment intervention. Contemp Clin Trials. 2023 Apr;127:107118. doi: 10.1016/j.cct.2023.107118. Epub 2023 Feb 14.
PubMed 36796623
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Resilience to Race-Based Stress: A Pilot Study
- ClinicalTrials.gov ID
- NCT05422638
- Acronym / sponsor ID
- RBSTE / D4070-P
- Conditions
- Life Stress, Racism
- Keywords
- Life stress, Racism, Health promotion, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Posted 29 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The existence of racially/ethnically based health disparities is well established, both within the civilian community and among Service Members and Veterans. Experiences of discrimination are acute and chronic stressors that substantially contribute to greater emotional distress, poorer health behavior, lower healthcare utilization and increased allostatic load, all of which undermine well-being, functioning and Whole Health. An innovative clinical program, the Race-Based Stress/Trauma and Empowerment (RBSTE) group, was developed to help Veterans of Color to build coping resources and empowerment. Although qualitative data suggest the promise of this intervention, systematic evaluation is lacking. The proposed feasibility project will lay the groundwork for a future randomized controlled trial to evaluate RBSTE as compared to a control group in terms of Whole Health, functioning and mental/physical wellness. The project thus begins a program of research to address the health implications of systemic racism.
Detailed description
Health disparities between White and Black, Indigenous and People of Color (BIPOC) are well documented in the United States; this phenomenon is driven in part by discrimination experiences and is an important contributor to well-being and functioning, including among military service members and Veterans. The chronic stress of racism has both psychological and physiological effects. Discrimination is associated with increased psychological distress, including higher rates of PTSD among Veterans of Color (VOC), poorer health behavior and decreased healthcare utilization. Race-based stress is also linked to increased allostatic load (AL), which is a measurable index of wear-and-tear on the body due to chronic stress exposure that is associated with greater disease burden and mortality. Recognizing the unmet need for interventions to help VOC process and cope with experiences of discrimination, the Race-based Stress/Trauma and Empowerment (RBSTE) intervention (Carlson, Endsley, Motley, Shawahin, \& Williams, 2018) was developed. RBSTE is a group-based approach that combines cultural adaptations of established psychotherapeutic techniques with novel strategies to foster resilience and empowerment for VOC. Initial qualitative data suggests the promise of this approach, but no systematic data are yet available to determine whether or not RBSTE is achieving its goals of enhancing coping and restoring well-being. The proposed project is a pilot randomized controlled trial (RCT) with multi-modal longitudinal assessment. Participants will be recruited from VA facilities and the surrounding community. VOC who report race-based stress, with minimal exclusions, will be evaluated at baseline, randomized in groups to one of two wellness interventions and then re-evaluated immediately after treatment. The interventions include RBSTE and Present Centered Therapy (PCT), designed to control for nonspecific aspects of RBSTE, including support and participation in an all-BIPOC group. The interventions will be delivered in 8 weekly 90-minute group sessions by a trained mental health professional using videoconferencing. The aims of the project are (1) to assess the feasibility of recruiting VOC for an RCT of this nature; (2) to examine the acceptability and appropriateness of intervention content, the feasibility of participation, and participant's perceptions of provider behavior and attitudes; and (3) to establish the optimal strategy for quantifying mental and physical health outcomes for future studies. Thus, the project will set the stage for evaluation of RBSTE's efficacy and ultimately implementation. This critically important program of research will provide guidance as to best practices for the management of race-based stress, with the ultimate goal of eliminating health disparities for Veterans and the community more broadly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RBSTE is a group-based approach that combines cultural adaptations of established psychotherapeutic techniques with novel strategies to foster resilience and empowerment for VOC. PCT is a group-based approach that provides a safe space for VOC to discuss stressors and find adaptive of responding to them.
| Arm | Type | Receives |
|---|---|---|
| RBSTE | Experimental | Behavioral: RBSTE8-week health promotion group focused on supporting coping with racism and empowerment |
| PCT | Active comparator | Behavioral: PCT8-week health promotion group focused on providing support and facilitating problem solving |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identified as a BIPOC
- Veteran
- able to consent to study activities
- endorsing one or more perceived discrimination experiences on the Everyday Discrimination Form (short version) or the Major Experiences of Discrimination Scale (abbreviated version) "a few times a year" or more frequently and endorsing stress on a validated single-item measure
Key exclusion criteria (3 listed)
- serious mental illness, alcohol/substance use disorders, or cognitive impairment that may interfere with the ability to benefit from group
- serious suicidality or homicidality (e.g., ideation with plan/intent) that is likely to require urgent/emergent intervention within the study period
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 |
|---|---|---|
| RBSTE8-week health promotion group focused on supporting coping with racism and empowerment | Behavioural | RBSTE |
| PCTAlso: Present Centered Therapy8-week health promotion group focused on providing support and facilitating problem solving | Behavioural | PCT |
Primary outcome
Enrollment Rate
Time frame: week 0
Percentage of individuals enrolled out of total contacted
Initiation Rate
Time frame: week 1
Percentage of subjects who initiate any intervention among all enrolled subjects
Per Protocol Completion
Time frame: week 8
Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Intent-to-treat Completion
Time frame: week 8
Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Acceptability of Intervention Measure (AIM)
Time frame: week 8
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Intervention Appropriateness Measure (IAM)
Time frame: week 8
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Feasibility of Intervention Measure (FIM)
Time frame: week 8
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
3 secondary outcomes
Brief Personal Health Inventory (B-PHI): Physical Health
Time frame: change from week 1 to week 8
Brief Personal Health Inventory (B-PHI): Mental Health
Time frame: change from week 1 to week 8
Brief Personal Health Inventory (B-PHI): Daily Living
Time frame: change from week 1 to week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36796623Wang C, Malaktaris A, McLean CL, Kelsven S, Chu GM, Ross KS, Endsley M Jr, Minassian A, Liu L, Hong S, Lang AJ. Mitigating the health effects of systemic racism: Evaluation of the Race-Based Stress and Trauma Empowerment intervention. Contemp Clin Trials. 2023 Apr;127:107118. doi: 10.1016/j.cct.2023.107118. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
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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.
Ariel J. Lang, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBSTE and PCT in people with Life Stress and Racism, run by VA Office of Research and Development 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Dec 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?
Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment Rate (time frame: week 0). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422638, which also lists 1 linked publication.
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 29 Dec 2025.