Initial Testing of Whole Health STEPS

NCT ID: NCT04390451

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2025-04-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Whole Health STEPS

Participants will immediately receive Whole Health STEPS.

Group Type: EXPERIMENTAL

Whole Health STEPS

Intervention Type: BEHAVIORAL

A peer-delivered package of Whole Health services.

Waitlist

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

Group Type: OTHER

Whole Health STEPS

Intervention Type: BEHAVIORAL

A peer-delivered package of Whole Health services.

Interventions

Whole Health STEPS

A peer-delivered package of Whole Health services.

Intervention Type: BEHAVIORAL

Other Intervention Names

Whole Health Structured Tiered Engagement with Peer Support

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily M. Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Syracuse VA Medical Center, Syracuse, NY

Locations

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

D3390-W

Identifier Type: -

Identifier Source: org_study_id