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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.

Results posted on

2020-12-21

Participant Flow

Participant milestones

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

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

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

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

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

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 onset

Population: 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

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 events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 315-425-4400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place