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NCT04390451 Clinical Trial

Initial Testing of Whole Health STEPS

Mental Health Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04390451
Other study ID # D3390-W
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 54
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Syracuse VA Medical Center, Syracuse, NY Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 4 months
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