Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05422638
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-06-13
Brief Title:
Race-Based Stress Trauma and Empowerment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Fostering Resilience to Race-Based Stress A Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RBSTE
Brief Summary:
The existence of raciallyethnically 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 StressTrauma 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 mentalphysical 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 StressTrauma 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 participants 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 RBSTEs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I21RX004070-01A1 | NIH | None | httpsreporternihgovquickSearch1I21RX004070-01A1 |