跳至主要内容
临床试验/NCT05422638
NCT05422638已完成不适用

Fostering Resilience to Race-Based Stress: A Pilot Study

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Acceptability of Intervention Measure (AIM)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-identified as a BIPOC
  • 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

排除标准

  • 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

结局指标

主要结局

Acceptability of Intervention Measure (AIM)

时间窗: week 8

Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability

Intervention Appropriateness Measure (IAM)

时间窗: week 8

Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness

Feasibility of Intervention Measure (FIM)

时间窗: week 8

Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility

Enrollment Rate

时间窗: week 0

Percentage of individuals enrolled out of total contacted

Per Protocol Completion

时间窗: week 8

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

Acceptability of Intervention Measure (AIM)

时间窗: week 8

Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability

Feasibility of Intervention Measure (FIM)

时间窗: week 8

Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility

Initiation Rate

时间窗: week 1

Percentage of subjects who initiate any intervention among all enrolled subjects

Intent-to-treat Completion

时间窗: week 8

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

Intervention Appropriateness Measure (IAM)

时间窗: week 8

Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness

次要结局

  • Brief Personal Health Inventory (B-PHI): Mental Health(change from week 1 to week 8)
  • Brief Personal Health Inventory (B-PHI): Physical Health(change from week 1 to week 8)
  • Brief Personal Health Inventory (B-PHI): Daily Living(change from week 1 to week 8)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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