An interventional study of RBSTE and PCT in Life Stress and Racism, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
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.
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.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's enrollment of 37 is below the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
serious mental illness, alcohol/substance use disorders, or cognitive impairment that may interfere with the ability to benefit from group
8-week health promotion group focused on supporting coping with racism and empowerment
Behavioral: RBSTE
8-week health promotion group focused on providing support and facilitating problem solving
Behavioral: PCT
8-week health promotion group focused on supporting coping with racism and empowerment
8-week health promotion group focused on providing support and facilitating problem solving
Also known as: Present Centered Therapy
Enrollment Rate
Percentage of individuals enrolled out of total contacted
Time frame: week 0
Initiation Rate
Percentage of subjects who initiate any intervention among all enrolled subjects
Time frame: week 1
Per Protocol Completion
Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Time frame: week 8
Intent-to-treat Completion
Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Time frame: week 8
Acceptability of Intervention Measure (AIM)
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Time frame: week 8
Intervention Appropriateness Measure (IAM)
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Time frame: week 8
Feasibility of Intervention Measure (FIM)
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Time frame: week 8
Brief Personal Health Inventory (B-PHI): Physical Health
self-appraisal of physical well being range 1-5 with higher scores indicating better health
Time frame: 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
Time frame: 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
Time frame: change from week 1 to week 8
| Milestone | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Started | 19 | 18 |
| Completed | 11 | 16 |
| Not completed | 8 | 2 |
| Withdrew: Withdrawal by subject | 8 | 2 |
Percentage of individuals enrolled out of total contacted
| percentage of individuals approached | Total Sample |
|---|---|
| Enrollment Rate | 8.87 |
Percentage of subjects who initiate any intervention among all enrolled subjects
| percentage of enrolled individuals | RBSTE | PCWG |
|---|---|---|
| Initiation Rate | 73.7 | 100 |
Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
| percent inititiators completed 5+ | RBSTE | PCWG |
|---|---|---|
| Per Protocol Completion | 64.7 | 94.1 |
Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
| percentage of ITT completed 5+ | RBSTE | PCWG |
|---|---|---|
| Intent-to-treat Completion | 57.9 | 88.9 |
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
| total score on a scale | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | 18.43 ± 1.81 | 14.75 ± 3.84 |
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
| total score on a scale | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Intervention Appropriateness Measure (IAM) | 17.57 ± 2.70 | 14.25 ± 3.77 |
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
| total score on a scale | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | 17.43 ± 2.22 | 14.88 ± 3.52 |
self-appraisal of physical well being range 1-5 with higher scores indicating better health
| change score on a scale | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Brief Personal Health Inventory (B-PHI): Physical Health | 0.1 ± 0.88 | 0.27 ± 0.53 |
self-appraisal of mental well being range 1-5 with higher scores indicating better mental health
| change in score on a scale | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Brief Personal Health Inventory (B-PHI): Mental Health | 0.97 ± 1.14 | 0.61 ± 0.76 |
self-appraisal of daily living range 1-5 with higher scores indicating better daily living
| change in score on a scale | Race-Based Stress Trauma & Empowerment (RBSTE) | Present-Centered Wellness Group (PCWG) |
|---|---|---|
| Brief Personal Health Inventory (B-PHI): Daily Living | 1.07 ± 0.99 | 0.43 ± 0.93 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Race-Based Stress Trauma & Empowerment (RBSTE) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Present-Centered Wellness Group (PCWG) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | RBSTE | PCWG | Total |
|---|---|---|---|
| Mean | 56.2 ± 17 | 46.9 ± 14.6 | 49.9 ± 16.2 |
| Sex: Female, Male(Participants) | RBSTE | PCWG | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 13 | 12 | 25 |
| Ethnicity (NIH/OMB)(Participants) | RBSTE | PCWG | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 11 |
| Not Hispanic or Latino | 13 | 12 | 25 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | RBSTE | PCWG | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 12 | 24 |
| White | 4 | 5 | 9 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | RBSTE | PCWG | Total |
|---|---|---|---|
| United States | 19 | 18 | 37 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2023 to primary completion in Sep 2024, 20 months.
Results were first posted in Dec 2025, 1 year 2 months after primary completion.
Of 457 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 20 months is above that.
Counting every sponsor, half of 470 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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