Trial Outcomes & Findings for Initial Testing of Whole Health STEPS (NCT NCT04390451)
NCT ID: NCT04390451
Last Updated: 2026-04-16
Results Overview
This 80 item self-report inventory measures several domains of psychosocial functioning (e.g., family relationships, work, self-care) on a 0-100 scale with lower scores indicating better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Assessed at Baseline (at enrollment), Mid (2-3 months after enrollment), and Final (2-3 months after Mid). Open Trial participants only completed Baseline and Mid assessments. Pre-intervention and Post-Intervention timepoints are relative to trial arm.
Results posted on
2026-04-16
Participant Flow
Of 82 enrolled participants, 55 met all eligibility criteria to participate. The first 11 eligible participants completed an open trial phase focused on establishing feasibility and acceptability. The remaining 44 eligible participants were randomized to evaluate patient outcomes.
Participant milestones
| Measure |
Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support)
The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized)
Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Waitlist
Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
21
|
23
|
|
Overall Study
Mid-Assessment (Post-Intervention for Immediate Whole Health STEPS, Pre-Intervention for Waitlist)
|
9
|
19
|
22
|
|
Overall Study
COMPLETED
|
9
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initial Testing of Whole Health STEPS
Baseline characteristics by cohort
| Measure |
Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support)
n=11 Participants
The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized)
n=21 Participants
Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Waitlist
n=23 Participants
Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
4 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
39 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
2 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
4 Participants
n=13 Participants
|
|
Age, Continuous
|
58.36 Years
STANDARD_DEVIATION 9.53 • n=193 Participants
|
56.52 Years
STANDARD_DEVIATION 11.88 • n=193 Participants
|
55.83 Years
STANDARD_DEVIATION 13.57 • n=386 Participants
|
56.60 Years
STANDARD_DEVIATION 12.04 • n=13 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
10 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=193 Participants
|
16 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
45 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
13 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=193 Participants
|
19 Participants
n=193 Participants
|
21 Participants
n=386 Participants
|
50 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
|
Positive Depression Screening on the Personal Health Questionnaire-9 (PHQ-9)
|
6 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
29 Participants
n=13 Participants
|
|
Positive Post-Traumatic Stress Disorder (PTSD) Screening on the PTSD Checklist for DSM-5 (PCL-5)
|
2 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
19 Participants
n=13 Participants
|
|
Positive Anxiety Screening on the Generalized Anxiety Disorder-7 (GAD-7)
|
5 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
31 Participants
n=13 Participants
|
|
Positive Hazardous Alcohol Use Screening Alcohol Use Disorders Identification Test (AUDIT)
|
7 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
26 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline (at enrollment), Mid (2-3 months after enrollment), and Final (2-3 months after Mid). Open Trial participants only completed Baseline and Mid assessments. Pre-intervention and Post-Intervention timepoints are relative to trial arm.Population: Analyses reported on ClinicalTrials.gov are based on participants who completed all timepoints.
This 80 item self-report inventory measures several domains of psychosocial functioning (e.g., family relationships, work, self-care) on a 0-100 scale with lower scores indicating better outcomes.
Outcome measures
| Measure |
Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support)
n=9 Participants
The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized)
n=18 Participants
Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Waitlist
n=20 Participants
Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months.
|
|---|---|---|---|
|
Inventory of Psychosocial Functioning (IPF)
Baseline (Open Trial=Pre-Intervention; WH-STEPS=Pre-Intervention)
|
32.60 score on a scale
Standard Deviation 14.47
|
32.69 score on a scale
Standard Deviation 8.97
|
33.51 score on a scale
Standard Deviation 12.23
|
|
Inventory of Psychosocial Functioning (IPF)
Mid (Open Trial=Post-Intervention; WH-STEPS=Post-Intervention; Waitlist=Pre-Intervention)
|
29.30 score on a scale
Standard Deviation 9.89
|
27.67 score on a scale
Standard Deviation 10.62
|
34.10 score on a scale
Standard Deviation 12.82
|
|
Inventory of Psychosocial Functioning (IPF)
Final (Open Trial=Last Observation Carried Forward; WH-STEPS=2 month Follow-up; Waitlist=Post-Int)
|
29.30 score on a scale
Standard Deviation 9.89
|
30.47 score on a scale
Standard Deviation 11.63
|
28.07 score on a scale
Standard Deviation 11.14
|
Adverse Events
Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Waitlist
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support)
n=11 participants at risk
The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized)
n=21 participants at risk
Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress.
|
Waitlist
n=23 participants at risk
Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months.
|
|---|---|---|---|
|
General disorders
Emergency Room Visits for Medical Concerns Un-related to the Study
|
0.00%
0/11 • From enrollment to end of follow-up, ~6 months
|
4.8%
1/21 • From enrollment to end of follow-up, ~6 months
|
8.7%
2/23 • From enrollment to end of follow-up, ~6 months
|
Additional Information
Emily M. Johnson, PhD
VA Center for Integrated Healthcare, Syracuse VA Medical Center
Phone: 315-425-3487
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place