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OpenTrials
Completed

NCT Number: NCT04390451

Initial Testing of Whole Health STEPS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Health STEPS

Behavioral

A peer-delivered package of Whole Health services.

Other names: Whole Health Structured Tiered Engagement with Peer Support

Primary outcomes

  1. Inventory of Psychosocial Functioning (IPF)

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 15, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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