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Completed

NCT Number: NCT05422638

Race-Based Stress Trauma and Empowerment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBSTE

Behavioral

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

PCT

Behavioral

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

Other names: Present Centered Therapy

Primary outcomes

  1. Enrollment Rate

    Time frame: week 0

    Percentage of individuals enrolled out of total contacted

  2. Initiation Rate

    Time frame: week 1

    Percentage of subjects who initiate any intervention among all enrolled subjects

  3. Per Protocol Completion

    Time frame: week 8

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

  4. Intent-to-treat Completion

    Time frame: week 8

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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. Brief Personal Health Inventory (B-PHI): Physical Health

    Time frame: change from week 1 to week 8

    self-appraisal of physical well being range 1-5 with higher scores indicating better health

  2. Brief Personal Health Inventory (B-PHI): Mental Health

    Time frame: change from week 1 to week 8

    self-appraisal of mental well being range 1-5 with higher scores indicating better mental health

  3. Brief Personal Health Inventory (B-PHI): Daily Living

    Time frame: change from week 1 to week 8

    self-appraisal of daily living range 1-5 with higher scores indicating better daily living

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Fostering Resilience to Race-Based Stress: A Pilot Study

Acronym: RBSTE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 16, 2022
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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