Initial Testing of Whole Health STEPS

NCT04390451 | Completed Results

• 1 other identifier: D3390-W
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health

Keywords

Primary Health Care; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Whole Health STEPS

EXPERIMENTAL

Participants will immediately receive Whole Health STEPS.

Behavioral: Whole Health STEPS

Waitlist

OTHER

Participants will receive Whole Health STEPS after a defined waiting period.

Behavioral: Whole Health STEPS

Interventions

Whole Health STEPS BEHAVIORAL

A peer-delivered package of Whole Health services.

Also known as: Whole Health Structured Tiered Engagement with Peer Support

Waitlist; Whole Health STEPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Emily M. Johnson, PhD
• Organization: VA Center for Integrated Healthcare, Syracuse VA Medical Center

Emily.Johnson1@va.gov

315-425-3487

Study Officials

• Emily M. Johnson, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study compares Whole Health STEPS to a waitlist control.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 15, 2020
• Study Start: April 25, 2022
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The dataset will be available following publication of the primary manuscript for this project.
• Access Criteria: The dataset will be released upon written request for scientific purposes including re-analysis and validation of results.

Locations

US (1)