Race-Based Stress Trauma and Empowerment

NCT ID: NCT05422638

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2024-12-31

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.

Conditions

Life Stress; Racism

Keywords

Life stress; Racism; Health promotion; Randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RBSTE

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

Group Type: EXPERIMENTAL

RBSTE

Intervention Type: BEHAVIORAL

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

PCT

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

Group Type: ACTIVE_COMPARATOR

PCT

Intervention Type: BEHAVIORAL

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

Interventions

RBSTE

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

Intervention Type: BEHAVIORAL

PCT

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Present Centered Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariel J. Lang, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36796623 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1I21RX004070-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D4070-P

Identifier Type: -

Identifier Source: org_study_id