Initial Testing of Whole Health STEPS

Not Applicable

Completed

• Conditions: Mental Health
• Interventions: Behavioral: Whole Health STEPS

• Registration Number: NCT04390451
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-15
• Study Start: 2022-04-25
• Status Verified: 2025-04
• Primary Completion: 2025-04-03
• Study Completion: 2025-04-03
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist	Whole Health STEPS	Participants will receive Whole Health STEPS after a defined waiting period.
Whole Health STEPS	Whole Health STEPS	Participants will immediately receive Whole Health STEPS.

Primary Outcome Measures

Name	Time	Method
Inventory of Psychosocial Functioning (IPF)	4 months	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.

Trial Locations

Locations (1)

Syracuse VA Medical Center, Syracuse, NY; 🇺🇸 Syracuse, New York, United States