Trial Outcomes & Findings for Peer-Delivered Whole Health Coaching for Veterans With PTSD (NCT NCT03364192)
NCT ID: NCT03364192
Last Updated: 2020-12-21
Results Overview
Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains.
COMPLETED
NA
28 participants
Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.
2020-12-21
Participant Flow
Participant milestones
| Measure |
Peer-delivered Whole Health Coaching
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Peer-delivered Whole Health Coaching
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.
|
|---|---|
|
Overall Study
Ineligible
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Peer-Delivered Whole Health Coaching for Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Peer-delivered Whole Health Coaching
n=17 Participants
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.
|
|---|---|
|
Age, Continuous
|
51.71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.Population: Participants were included in this analysis if they initiated peer-delivered Whole Health Coaching within 2 weeks of their designated start date, if they met the baseline stability criterion (at least four data points on the primary outcome, the final two of which had to fall within the range of the previous two data points, for at least 5 of the 9 domains), and if they completed at least three assessments during the intervention phase.
Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains.
Outcome measures
| Measure |
Peer-delivered Whole Health Coaching
n=10 Participants
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
|
|---|---|
|
Goal Attainment Scaling (GAS)
Baseline Phase
|
2.33 score on a scale
Standard Error 0.90
|
|
Goal Attainment Scaling (GAS)
Peer-Delivered Whole Health Coaching Phase
|
4.15 score on a scale
Standard Error 0.75
|
|
Goal Attainment Scaling (GAS)
Maintenance/Follow-up Phase
|
4.63 score on a scale
Standard Error 1.09
|
SECONDARY outcome
Timeframe: Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.Population: Only participants included in the primary analysis are analyzed here.
The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms. The total sum score ranges from 0-80 with lower scores indicating more positive outcomes.
Outcome measures
| Measure |
Peer-delivered Whole Health Coaching
n=10 Participants
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Baseline
|
42.4 score on a scale
Standard Error 4.40
|
|
PTSD Checklist for DSM-5 (PCL-5)
Before Peer-Delivered Whole Health Coaching
|
53.5 score on a scale
Standard Error 4.40
|
|
PTSD Checklist for DSM-5 (PCL-5)
After Peer-Delivered Whole Health Coaching
|
49.22 score on a scale
Standard Error 4.67
|
|
PTSD Checklist for DSM-5 (PCL-5)
Follow-up (24 weeks)
|
49.61 score on a scale
Standard Error 4.67
|
SECONDARY outcome
Timeframe: Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.Population: Only participants meeting criteria for inclusion in the primary analysis are included here.
The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains. The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care). Scores range from 0-100 with lower scores indicating more positive outcomes.
Outcome measures
| Measure |
Peer-delivered Whole Health Coaching
n=10 Participants
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
|
|---|---|
|
Inventory of Psychosocial Functioning (IPF)
Baseline
|
38.74 score on a scale
Standard Error 4.54
|
|
Inventory of Psychosocial Functioning (IPF)
Before Peer-Delivered Whole Health Coaching
|
30.49 score on a scale
Standard Error 4.54
|
|
Inventory of Psychosocial Functioning (IPF)
After Peer-Delivered Whole Health Coaching
|
28.24 score on a scale
Standard Error 4.77
|
|
Inventory of Psychosocial Functioning (IPF)
Follow-Up (24 weeks)
|
28.59 score on a scale
Standard Error 4.77
|
SECONDARY outcome
Timeframe: 8 weeks following intervention onsetPopulation: The CSQ-8 was analyzed for all participants with non-missing data at this timepoint.
Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service. CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes.
Outcome measures
| Measure |
Peer-delivered Whole Health Coaching
n=11 Participants
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
|
|---|---|
|
Client Satisfaction Questionnaire
|
27.18 score on a scale
Standard Deviation 4.07
|
Adverse Events
Peer-delivered Whole Health Coaching
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peer-delivered Whole Health Coaching
n=18 participants at risk
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Non-Serious Adverse Event-Unrelated to Study Participation
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
Additional Information
Emily M. Johnson, Ph.D., PI
VA Center for Integrated Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place