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Race-Based Stress Trauma and Empowerment

Fostering Resilience to Race-Based Stress: A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05422638
Acronym
RBSTE
Enrollment
37
Registered
2022-06-16
Start date
2023-01-02
Completion date
2024-12-31
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Life Stress, Racism

Keywords

Life stress, Racism, Health promotion, Randomized controlled trial

Brief 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 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.

Interventions

BEHAVIORALRBSTE

8-week health promotion group focused on supporting coping with racism and empowerment

BEHAVIORALPCT

8-week health promotion group focused on providing support and facilitating problem solving

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention Measure (FIM)week 8Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Intent-to-treat Completionweek 8Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Acceptability of Intervention Measure (AIM)week 8Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Intervention Appropriateness Measure (IAM)week 8Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Enrollment Rateweek 0Percentage of individuals enrolled out of total contacted
Initiation Rateweek 1Percentage of subjects who initiate any intervention among all enrolled subjects
Per Protocol Completionweek 8Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention

Secondary

MeasureTime frameDescription
Brief Personal Health Inventory (B-PHI): Mental Healthchange from week 1 to week 8self-appraisal of mental well being range 1-5 with higher scores indicating better mental health
Brief Personal Health Inventory (B-PHI): Daily Livingchange from week 1 to week 8self-appraisal of daily living range 1-5 with higher scores indicating better daily living
Brief Personal Health Inventory (B-PHI): Physical Healthchange from week 1 to week 8self-appraisal of physical well being range 1-5 with higher scores indicating better health

Countries

United States

Participant flow

Participants by arm

ArmCount
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
19
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
18
Total37

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject82

Baseline characteristics

CharacteristicRBSTETotalPCWG
Age, Continuous56.2 years
STANDARD_DEVIATION 17
49.9 years
STANDARD_DEVIATION 16.2
46.9 years
STANDARD_DEVIATION 14.6
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants11 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants25 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
12 Participants24 Participants12 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
4 Participants9 Participants5 Participants
Region of Enrollment
United States
19 participants37 participants18 participants
Sex: Female, Male
Female
6 Participants12 Participants6 Participants
Sex: Female, Male
Male
13 Participants25 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 18
other
Total, other adverse events
0 / 190 / 18
serious
Total, serious adverse events
0 / 190 / 18

Outcome results

Primary

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

Population: Reduced numbers reflect missing data

ArmMeasureValue (MEAN)Dispersion
Total SampleAcceptability of Intervention Measure (AIM)18.43 total score on a scaleStandard Deviation 1.81
PCWGAcceptability of Intervention Measure (AIM)14.75 total score on a scaleStandard Deviation 3.84
Primary

Enrollment Rate

Percentage of individuals enrolled out of total contacted

Time frame: week 0

ArmMeasureValue (NUMBER)
Total SampleEnrollment Rate8.87 percentage of individuals approached
Primary

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

Population: Reduced numbers reflect missing data

ArmMeasureValue (MEAN)Dispersion
Total SampleFeasibility of Intervention Measure (FIM)17.43 total score on a scaleStandard Deviation 2.22
PCWGFeasibility of Intervention Measure (FIM)14.88 total score on a scaleStandard Deviation 3.52
Primary

Initiation Rate

Percentage of subjects who initiate any intervention among all enrolled subjects

Time frame: week 1

Population: Participants did not know their condition until they arrived for the first session, so these data should not be interpreted by group.

ArmMeasureValue (NUMBER)
Total SampleInitiation Rate73.7 percentage of enrolled individuals
PCWGInitiation Rate100 percentage of enrolled individuals
Primary

Intent-to-treat Completion

Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects

Time frame: week 8

ArmMeasureValue (NUMBER)
Total SampleIntent-to-treat Completion57.9 percentage of ITT completed 5+
PCWGIntent-to-treat Completion88.9 percentage of ITT completed 5+
Primary

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

Population: Reduced numbers reflect missing data

ArmMeasureValue (MEAN)Dispersion
Total SampleIntervention Appropriateness Measure (IAM)17.57 total score on a scaleStandard Deviation 2.7
PCWGIntervention Appropriateness Measure (IAM)14.25 total score on a scaleStandard Deviation 3.77
Primary

Per Protocol Completion

Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention

Time frame: week 8

Population: Includes the 34 participants of the 37 enrolled who initiated intervention.

ArmMeasureValue (NUMBER)
Total SamplePer Protocol Completion64.7 percent inititiators completed 5+
PCWGPer Protocol Completion94.1 percent inititiators completed 5+
Secondary

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

Population: Reduced numbers reflect missing data

ArmMeasureValue (MEAN)Dispersion
Total SampleBrief Personal Health Inventory (B-PHI): Daily Living1.07 change in score on a scaleStandard Deviation 0.99
PCWGBrief Personal Health Inventory (B-PHI): Daily Living0.43 change in score on a scaleStandard Deviation 0.93
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

Time frame: change from week 1 to week 8

Population: Reduced numbers reflect missing data

ArmMeasureValue (MEAN)Dispersion
Total SampleBrief Personal Health Inventory (B-PHI): Mental Health0.97 change in score on a scaleStandard Deviation 1.14
PCWGBrief Personal Health Inventory (B-PHI): Mental Health0.61 change in score on a scaleStandard Deviation 0.76
Secondary

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

Population: Reduced numbers reflect missing data

ArmMeasureValue (MEAN)Dispersion
Total SampleBrief Personal Health Inventory (B-PHI): Physical Health0.1 change score on a scaleStandard Deviation 0.88
PCWGBrief Personal Health Inventory (B-PHI): Physical Health0.27 change score on a scaleStandard Deviation 0.53

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026