Trial Outcomes & Findings for Race-Based Stress Trauma and Empowerment (NCT NCT05422638)
NCT ID: NCT05422638
Last Updated: 2025-12-29
Results Overview
Percentage of individuals enrolled out of total contacted
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
week 0
Results posted on
2025-12-29
Participant Flow
Participant milestones
| Measure |
Race-Based Stress Trauma & Empowerment (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
|
Present-Centered Wellness Group (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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Race-Based Stress Trauma & Empowerment (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
|
Present-Centered Wellness Group (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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
Baseline Characteristics
Race-Based Stress Trauma and Empowerment
Baseline characteristics by cohort
| Measure |
RBSTE
n=19 Participants
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
|
PCWG
n=18 Participants
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
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 17 • n=9 Participants
|
46.9 years
STANDARD_DEVIATION 14.6 • n=6 Participants
|
49.9 years
STANDARD_DEVIATION 16.2 • n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=9 Participants
|
18 participants
n=6 Participants
|
37 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: week 0Percentage of individuals enrolled out of total contacted
Outcome measures
| Measure |
Total Sample
n=417 Participants
All individuals approached about the study
|
PCWG
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Enrollment Rate
|
8.87 percentage of individuals approached
|
—
|
PRIMARY outcome
Timeframe: week 1Population: Participants did not know their condition until they arrived for the first session, so these data should not be interpreted by group.
Percentage of subjects who initiate any intervention among all enrolled subjects
Outcome measures
| Measure |
Total Sample
n=19 Participants
All individuals approached about the study
|
PCWG
n=18 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Initiation Rate
|
73.7 percentage of enrolled individuals
|
100 percentage of enrolled individuals
|
PRIMARY outcome
Timeframe: week 8Population: Includes the 34 participants of the 37 enrolled who initiated intervention.
Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention
Outcome measures
| Measure |
Total Sample
n=17 Participants
All individuals approached about the study
|
PCWG
n=17 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Per Protocol Completion
|
64.7 percent inititiators completed 5+
|
94.1 percent inititiators completed 5+
|
PRIMARY outcome
Timeframe: week 8Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects
Outcome measures
| Measure |
Total Sample
n=19 Participants
All individuals approached about the study
|
PCWG
n=18 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Intent-to-treat Completion
|
57.9 percentage of ITT completed 5+
|
88.9 percentage of ITT completed 5+
|
PRIMARY outcome
Timeframe: week 8Population: Reduced numbers reflect missing data
Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability
Outcome measures
| Measure |
Total Sample
n=7 Participants
All individuals approached about the study
|
PCWG
n=8 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
|
18.43 total score on a scale
Standard Deviation 1.81
|
14.75 total score on a scale
Standard Deviation 3.84
|
PRIMARY outcome
Timeframe: week 8Population: Reduced numbers reflect missing data
Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness
Outcome measures
| Measure |
Total Sample
n=7 Participants
All individuals approached about the study
|
PCWG
n=8 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Intervention Appropriateness Measure (IAM)
|
17.57 total score on a scale
Standard Deviation 2.70
|
14.25 total score on a scale
Standard Deviation 3.77
|
PRIMARY outcome
Timeframe: week 8Population: Reduced numbers reflect missing data
Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility
Outcome measures
| Measure |
Total Sample
n=7 Participants
All individuals approached about the study
|
PCWG
n=8 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
|
17.43 total score on a scale
Standard Deviation 2.22
|
14.88 total score on a scale
Standard Deviation 3.52
|
SECONDARY outcome
Timeframe: change from week 1 to week 8Population: Reduced numbers reflect missing data
self-appraisal of physical well being range 1-5 with higher scores indicating better health
Outcome measures
| Measure |
Total Sample
n=10 Participants
All individuals approached about the study
|
PCWG
n=8 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Brief Personal Health Inventory (B-PHI): Physical Health
|
0.1 change score on a scale
Standard Deviation 0.88
|
0.27 change score on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: change from week 1 to week 8Population: Reduced numbers reflect missing data
self-appraisal of mental well being range 1-5 with higher scores indicating better mental health
Outcome measures
| Measure |
Total Sample
n=10 Participants
All individuals approached about the study
|
PCWG
n=8 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Brief Personal Health Inventory (B-PHI): Mental Health
|
0.97 change in score on a scale
Standard Deviation 1.14
|
0.61 change in score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: change from week 1 to week 8Population: Reduced numbers reflect missing data
self-appraisal of daily living range 1-5 with higher scores indicating better daily living
Outcome measures
| Measure |
Total Sample
n=10 Participants
All individuals approached about the study
|
PCWG
n=8 Participants
Individuals who were enrolled in the study and assigned to PCWG
|
|---|---|---|
|
Brief Personal Health Inventory (B-PHI): Daily Living
|
1.07 change in score on a scale
Standard Deviation 0.99
|
0.43 change in score on a scale
Standard Deviation 0.93
|
Adverse Events
Race-Based Stress Trauma & Empowerment (RBSTE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Present-Centered Wellness Group (PCWG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place