Initial Testing of Whole Health STEPS

Overview

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.

Full Title of Study: “Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2024

Interventions

  • Behavioral: Whole Health STEPS
    • A peer-delivered package of Whole Health services.

Arms, Groups and Cohorts

  • Experimental: Whole Health STEPS
    • Participants will immediately receive Whole Health STEPS.
  • Other: Waitlist
    • Participants will receive Whole Health STEPS after a defined waiting period.

Clinical Trial Outcome Measures

Primary Measures

  • Inventory of Psychosocial Functioning (IPF)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emily M. Johnson, PhD, Principal Investigator, Syracuse VA Medical Center, Syracuse, NY
  • Overall Contact(s)
    • Emily M Johnson, PhD, (315) 425-4400, emily.johnson1@va.gov

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