Life Stress, Racism
Conditions
Keywords
Life stress, Racism, Health promotion, Randomized controlled trial
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.
Interventions
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
Sponsors
Study design
Intervention 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | week 8 | Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility |
| Intent-to-treat Completion | week 8 | Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects |
| Acceptability of Intervention Measure (AIM) | week 8 | Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability |
| Intervention Appropriateness Measure (IAM) | week 8 | Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness |
| Enrollment Rate | week 0 | Percentage of individuals enrolled out of total contacted |
| Initiation Rate | week 1 | Percentage of subjects who initiate any intervention among all enrolled subjects |
| Per Protocol Completion | week 8 | Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Personal Health Inventory (B-PHI): Mental Health | change from week 1 to week 8 | self-appraisal of mental well being range 1-5 with higher scores indicating better mental health |
| Brief Personal Health Inventory (B-PHI): Daily Living | change from week 1 to week 8 | self-appraisal of daily living range 1-5 with higher scores indicating better daily living |
| Brief Personal Health Inventory (B-PHI): Physical Health | change from week 1 to week 8 | self-appraisal of physical well being range 1-5 with higher scores indicating better health |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RBSTE 8-week health promotion group focused on supporting coping with racism and empowerment
RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment | 19 |
| PCWG 8-week health promotion group focused on providing support and facilitating problem solving
PCWG: 8-week health promotion group focused on providing support and facilitating problem solving | 18 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | RBSTE | Total | PCWG |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 17 | 49.9 years STANDARD_DEVIATION 16.2 | 46.9 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 25 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 19 participants | 37 participants | 18 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 25 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Acceptability of Intervention Measure (AIM)
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Time frame: week 8
Population: Reduced numbers reflect missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Acceptability of Intervention Measure (AIM) | 18.43 total score on a scale | Standard Deviation 1.81 |
| PCWG | Acceptability of Intervention Measure (AIM) | 14.75 total score on a scale | Standard Deviation 3.84 |
Enrollment Rate
Percentage of individuals enrolled out of total contacted
Time frame: week 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Sample | Enrollment Rate | 8.87 percentage of individuals approached |
Feasibility of Intervention Measure (FIM)
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Time frame: week 8
Population: Reduced numbers reflect missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Feasibility of Intervention Measure (FIM) | 17.43 total score on a scale | Standard Deviation 2.22 |
| PCWG | Feasibility of Intervention Measure (FIM) | 14.88 total score on a scale | Standard Deviation 3.52 |
Initiation Rate
Percentage of subjects who initiate any intervention among all enrolled subjects
Time frame: week 1
Population: Participants did not know their condition until they arrived for the first session, so these data should not be interpreted by group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Sample | Initiation Rate | 73.7 percentage of enrolled individuals |
| PCWG | Initiation Rate | 100 percentage of enrolled individuals |
Intent-to-treat Completion
Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Time frame: week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Sample | Intent-to-treat Completion | 57.9 percentage of ITT completed 5+ |
| PCWG | Intent-to-treat Completion | 88.9 percentage of ITT completed 5+ |
Intervention Appropriateness Measure (IAM)
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Time frame: week 8
Population: Reduced numbers reflect missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Intervention Appropriateness Measure (IAM) | 17.57 total score on a scale | Standard Deviation 2.7 |
| PCWG | Intervention Appropriateness Measure (IAM) | 14.25 total score on a scale | Standard Deviation 3.77 |
Per Protocol Completion
Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Time frame: week 8
Population: Includes the 34 participants of the 37 enrolled who initiated intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Sample | Per Protocol Completion | 64.7 percent inititiators completed 5+ |
| PCWG | Per Protocol Completion | 94.1 percent inititiators completed 5+ |
Brief Personal Health Inventory (B-PHI): Daily Living
self-appraisal of daily living range 1-5 with higher scores indicating better daily living
Time frame: change from week 1 to week 8
Population: Reduced numbers reflect missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Brief Personal Health Inventory (B-PHI): Daily Living | 1.07 change in score on a scale | Standard Deviation 0.99 |
| PCWG | Brief Personal Health Inventory (B-PHI): Daily Living | 0.43 change in score on a scale | Standard Deviation 0.93 |
Brief Personal Health Inventory (B-PHI): Mental Health
self-appraisal of mental well being range 1-5 with higher scores indicating better mental health
Time frame: change from week 1 to week 8
Population: Reduced numbers reflect missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Brief Personal Health Inventory (B-PHI): Mental Health | 0.97 change in score on a scale | Standard Deviation 1.14 |
| PCWG | Brief Personal Health Inventory (B-PHI): Mental Health | 0.61 change in score on a scale | Standard Deviation 0.76 |
Brief Personal Health Inventory (B-PHI): Physical Health
self-appraisal of physical well being range 1-5 with higher scores indicating better health
Time frame: change from week 1 to week 8
Population: Reduced numbers reflect missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Brief Personal Health Inventory (B-PHI): Physical Health | 0.1 change score on a scale | Standard Deviation 0.88 |
| PCWG | Brief Personal Health Inventory (B-PHI): Physical Health | 0.27 change score on a scale | Standard Deviation 0.53 |