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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX004070-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBSTE | Experimental | 8-week health promotion group focused on supporting coping with racism and empowerment |
|
| PCT | Active Comparator | 8-week health promotion group focused on providing support and facilitating problem solving |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBSTE | Behavioral | 8-week health promotion group focused on supporting coping with racism and empowerment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Percentage of individuals enrolled out of total contacted | week 0 |
| Initiation Rate | Percentage of subjects who initiate any intervention among all enrolled subjects | week 1 |
| Per Protocol Completion | Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention | week 8 |
| Intent-to-treat Completion | Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects | week 8 |
| Acceptability of Intervention Measure (AIM) | Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability | week 8 |
| Intervention Appropriateness Measure (IAM) | Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness | week 8 |
| Feasibility of Intervention Measure (FIM) | Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Personal Health Inventory (B-PHI): Physical Health | self-appraisal of physical well being range 1-5 with higher scores indicating better health | change from week 1 to week 8 |
| Brief Personal Health Inventory (B-PHI): Mental Health |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Ariel J. Lang, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36796623 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Race-Based Stress Trauma & Empowerment (RBSTE) | 8-week health promotion group focused on supporting coping with racism and empowerment RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment |
| FG001 | Present-Centered Wellness Group (PCWG) | 8-week health promotion group focused on providing support and facilitating problem solving PCWG: 8-week health promotion group focused on providing support and facilitating problem solving |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | RBSTE | 8-week health promotion group focused on supporting coping with racism and empowerment RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment |
| BG001 | PCWG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment Rate | Percentage of individuals enrolled out of total contacted | Posted | Number | percentage of individuals approached | week 0 |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Race-Based Stress Trauma & Empowerment (RBSTE) | 8-week health promotion group focused on supporting coping with racism and empowerment RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariel J Lang, PhD, MPH | VA San Diego Healthcare System | 858-552-8585 | 5953 | ariel.lang@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2022 | Oct 20, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2022 | Oct 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D063505 | Racism |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011287 | Prejudice |
| D012919 | Social Behavior |
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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.
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| PCT | Behavioral | 8-week health promotion group focused on providing support and facilitating problem solving |
|
|
self-appraisal of mental well being range 1-5 with higher scores indicating better mental health
| 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 | change from week 1 to week 8 |
8-week health promotion group focused on providing support and facilitating problem solving
PCWG: 8-week health promotion group focused on providing support and facilitating problem solving
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Initiation Rate | Percentage of subjects who initiate any intervention among all enrolled subjects | Participants did not know their condition until they arrived for the first session, so these data should not be interpreted by group. | Posted | Number | percentage of enrolled individuals | week 1 |
|
|
|
| Primary | Per Protocol Completion | Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention | Includes the 34 participants of the 37 enrolled who initiated intervention. | Posted | Number | percent inititiators completed 5+ | week 8 |
|
|
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| Primary | Intent-to-treat Completion | Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects | Posted | Number | percentage of ITT completed 5+ | week 8 |
|
|
|
| Primary | Acceptability of Intervention Measure (AIM) | Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability | Reduced numbers reflect missing data | Posted | Mean | Standard Deviation | total score on a scale | week 8 |
|
|
|
| Primary | Intervention Appropriateness Measure (IAM) | Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness | Reduced numbers reflect missing data | Posted | Mean | Standard Deviation | total score on a scale | week 8 |
|
|
|
| Primary | Feasibility of Intervention Measure (FIM) | Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility | Reduced numbers reflect missing data | Posted | Mean | Standard Deviation | total score on a scale | week 8 |
|
|
|
| Secondary | Brief Personal Health Inventory (B-PHI): Physical Health | self-appraisal of physical well being range 1-5 with higher scores indicating better health | Reduced numbers reflect missing data | Posted | Mean | Standard Deviation | change score on a scale | change from week 1 to week 8 |
|
|
|
| Secondary | Brief Personal Health Inventory (B-PHI): Mental Health | self-appraisal of mental well being range 1-5 with higher scores indicating better mental health | Reduced numbers reflect missing data | Posted | Mean | Standard Deviation | change in score on a scale | change from week 1 to week 8 |
|
|
|
| Secondary | Brief Personal Health Inventory (B-PHI): Daily Living | self-appraisal of daily living range 1-5 with higher scores indicating better daily living | Reduced numbers reflect missing data | Posted | Mean | Standard Deviation | change in score on a scale | change from week 1 to week 8 |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Present-Centered Wellness Group (PCWG) | 8-week health promotion group focused on providing support and facilitating problem solving PCWG: 8-week health promotion group focused on providing support and facilitating problem solving | 0 | 18 | 0 | 18 | 0 | 18 |
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| D063508 |
| Social Discrimination |