Race-Based Stress Trauma and Empowerment

Racism Clinical Trial

— RBSTE  

Official title:

Fostering Resilience to Race-Based Stress: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422638
• Other study ID #: D4070-P
• Secondary ID: 1I21RX004070-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Ariel J Lang, PhD
• Phone: (858) 552-8585
• Email: Ariel.Lang[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Life Stress
• Racism
• Stress, Psychological

Intervention

Behavioral:
• RBSTE
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

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	proportion of consented subjects among all screened and eligible individuals	week 0
Primary	Initiation rate	proportion of subjects who initiate the intervention among all consented subjects	week 1
Primary	Per protocol completion	proportion of subjects who complete 5 or 6 sessions of intervention among those who start the intervention	week 8
Primary	Intent-to-treat completion	proportion of subjects who complete 5 or 6 sessions of intervention among all randomized subjects	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	week 8
Primary	Intervention Appropriateness Measure (IAM)	Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness	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	week 8
Secondary	Brief Personal Health Inventory (B-PHI)	self-appraisal of physical and mental/emotional well-being and daily life as well as ratings of one's current and ideal state for each of the nine areas in the VA Circle of Health and Well-being; Overall subscales: physical health: range 1-10 with higher scores indicating better health mental health: range 1-10 with higher scores indicating better health daily life: range 1-10 with higher scores indicating better functioning; Life area subscales (all rated for current (1-10) and ideal (1-10) with higher scores indicating preferred state): working the body, recharge, food and drink, personal development, family, friends and no-workers, spirit and soul, surroundings, power of the mind, professional care	week 8