Race-Based Stress Trauma and Empowerment

NCT05422638 | Completed Results

• 2 other identifiers: D4070-P1I21RX004070-01A1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Life Stress; Racism

Keywords

Life stress; Racism; Health promotion; Randomized controlled trial

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (3)

• Brief Personal Health Inventory (B-PHI): Physical Health

  change from week 1 to week 8

• Brief Personal Health Inventory (B-PHI): Mental Health

  change from week 1 to week 8

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

  change from week 1 to week 8

Study Arms (2)

RBSTE

EXPERIMENTAL

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

Behavioral: RBSTE

PCT

ACTIVE COMPARATOR

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

Behavioral: PCT

Interventions

RBSTE BEHAVIORAL

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

RBSTE

PCT BEHAVIORAL

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

Also known as: Present Centered Therapy

PCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

Related Publications (1)

• 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.

  PMID: 36796623 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Racism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Prejudice; Social Behavior; Social Discrimination

Results Point of Contact

• Title: Ariel J Lang, PhD, MPH
• Organization: VA San Diego Healthcare System

ariel.lang@va.gov

858-552-8585

Study Officials

• Ariel J. Lang, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: January 2, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 29, 2025
• Results First Posted: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)