Race-Based Stress Trauma and Empowerment (RBSTE)
Primary Purpose
Life Stress, Racism
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RBSTE
PCT
Sponsored by
About this trial
This is an interventional other trial for Life Stress focused on measuring Life stress, Racism, Health promotion, Randomized controlled trial
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
Sites / Locations
- VA San Diego Healthcare System, San Diego, CARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RBSTE
PCT
Arm Description
8-week health promotion group focused on supporting coping with racism and empowerment
8-week health promotion group focused on providing support and facilitating problem solving
Outcomes
Primary Outcome Measures
Enrollment rate
proportion of consented subjects among all screened and eligible individuals
Initiation rate
proportion of subjects who initiate the intervention among all consented subjects
Per protocol completion
proportion of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Intent-to-treat completion
proportion of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Acceptability of Intervention Measure (AIM)
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Intervention Appropriateness Measure (IAM)
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Feasibility of Intervention Measure (FIM)
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05422638
First Posted
June 13, 2022
Last Updated
January 13, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05422638
Brief Title
Race-Based Stress Trauma and Empowerment
Acronym
RBSTE
Official Title
Fostering Resilience to Race-Based Stress: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Life Stress, Racism
Keywords
Life stress, Racism, Health promotion, Randomized controlled trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RBSTE
Arm Type
Experimental
Arm Description
8-week health promotion group focused on supporting coping with racism and empowerment
Arm Title
PCT
Arm Type
Active Comparator
Arm Description
8-week health promotion group focused on providing support and facilitating problem solving
Intervention Type
Behavioral
Intervention Name(s)
RBSTE
Intervention Description
8-week health promotion group focused on supporting coping with racism and empowerment
Intervention Type
Behavioral
Intervention Name(s)
PCT
Other Intervention Name(s)
Present Centered Therapy
Intervention Description
8-week health promotion group focused on providing support and facilitating problem solving
Primary Outcome Measure Information:
Title
Enrollment rate
Description
proportion of consented subjects among all screened and eligible individuals
Time Frame
week 0
Title
Initiation rate
Description
proportion of subjects who initiate the intervention among all consented subjects
Time Frame
week 1
Title
Per protocol completion
Description
proportion of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Time Frame
week 8
Title
Intent-to-treat completion
Description
proportion of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Time Frame
week 8
Title
Acceptability of Intervention Measure (AIM)
Description
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Time Frame
week 8
Title
Intervention Appropriateness Measure (IAM)
Description
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Time Frame
week 8
Title
Feasibility of Intervention Measure (FIM)
Description
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Brief Personal Health Inventory (B-PHI)
Description
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
Time Frame
week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel J Lang, PhD
Phone
(619) 400-5173
Email
Ariel.Lang@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Clarice Wang, PhD
Phone
(760) 643-4485
Email
clarice.wang2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel J. Lang, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coralyn Ana
Phone
858-642-3657
Email
Coralyn.Ana@va.gov
First Name & Middle Initial & Last Name & Degree
Gerhard H Schulteis, PhD
Phone
(858) 642-3657
Email
gerhard.schulteis@va.gov
First Name & Middle Initial & Last Name & Degree
Ariel J. Lang, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Race-Based Stress Trauma and Empowerment
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