Initial Testing of Whole Health STEPS

Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)

This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Whole Health STEPS uses a Peer Support Specialist, or Peer, to provide support for Veterans to make progress on wellness goals using the Whole Health model. The level of support provided will be determined based on Veterans' progress and will be stepped-up until Veterans receive the level of support they need. Whole Health STEPS offers a non-mental health referral option for primary care Veterans with mental health concerns, provides a structured package of existing Whole Health services, and provides a structured service for peers in primary care settings.

Study Overview

• Status: Completed
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Whole Health STEPS

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210-2716
      • Syracuse VA Medical Center, Syracuse, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veteran status
• Enrolled in primary care at a participating site
• Have at least mild functional impairment
• Screen positive on at least one primary care mental health screener

Exclusion Criteria:

• Actively engaged with an equivalent or higher level of care
• Preference for direct referral to mental health care
• Recent changes to psychotropic medications
• Severe impairment preventing engagement in the intervention or warranting a direct referral to a licensed independent provider
• Inability to independently communicate in verbal and written English
• Inability to complete the research tasks or intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole Health STEPS; Participants will immediately receive Whole Health STEPS.	Behavioral: Whole Health STEPS; A peer-delivered package of Whole Health services.; Other Names: Whole Health Structured Tiered Engagement with Peer Support
Other: Waitlist; Participants will receive Whole Health STEPS after a defined waiting period.	Behavioral: Whole Health STEPS; A peer-delivered package of Whole Health services.; Other Names: Whole Health Structured Tiered Engagement with Peer Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inventory of Psychosocial Functioning (IPF)	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.	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.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Emily M. Johnson, PhD, Syracuse VA Medical Center, Syracuse, NY

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Primary Health Care
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: D3390-W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
• IPD Sharing Time Frame: The dataset will be available following publication of the primary manuscript for this project.
• IPD Sharing Access Criteria: The dataset will be released upon written request for scientific purposes including re-analysis and validation of results.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No