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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Health STEPS | Experimental | Participants will immediately receive Whole Health STEPS. |
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| Waitlist | Other | Participants will receive Whole Health STEPS after a defined waiting period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Health STEPS | Behavioral | A peer-delivered package of Whole Health services. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily M. Johnson, PhD | Syracuse VA Medical Center, Syracuse, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210-2716 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41961357 | Derived | Johnson EM, Possemato K, True G, Edelman EJ, Wade M, Sedotto R, Maisto SA, Chinman M. Peer Support for Whole Health: R esults from a mixed methods two phase pilot study. J Behav Med. 2026 Apr 10. doi: 10.1007/s10865-026-00656-4. Online ahead of print. |
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A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
The dataset will be available following publication of the primary manuscript for this project.
The dataset will be released upon written request for scientific purposes including re-analysis and validation of results.
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Of 82 enrolled participants, 55 met all eligibility criteria to participate. The first 11 eligible participants completed an open trial phase focused on establishing feasibility and acceptability. The remaining 44 eligible participants were randomized to evaluate patient outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support) | The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. |
| FG001 | Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized) | Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. |
| FG002 | Waitlist | Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support) | The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analyses reported on ClinicalTrials.gov are based on participants who completed all timepoints. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
From enrollment to end of follow-up, ~6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Trial Whole Health STEPS (Structured Tiered Engagement With Peer Support) | The first 11 eligible participants received Whole Health STEPS (Structured Tiered Engagement with Peer Support) and were not randomized. Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visits for Medical Concerns Un-related to the Study | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily M. Johnson, PhD | VA Center for Integrated Healthcare, Syracuse VA Medical Center | 315-425-3487 | Emily.Johnson1@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2025 | Mar 25, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2023 | Apr 16, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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The study compares Whole Health STEPS to a waitlist control.
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| BG001 | Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized) | Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. |
| BG002 | Waitlist | Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Positive Depression Screening on the Personal Health Questionnaire-9 (PHQ-9) | Count of Participants | Participants |
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| Positive Post-Traumatic Stress Disorder (PTSD) Screening on the PTSD Checklist for DSM-5 (PCL-5) | Count of Participants | Participants |
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| Positive Anxiety Screening on the Generalized Anxiety Disorder-7 (GAD-7) | Count of Participants | Participants |
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| Positive Hazardous Alcohol Use Screening Alcohol Use Disorders Identification Test (AUDIT) | Count of Participants | Participants |
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| OG001 | Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized) | Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. |
| OG002 | Waitlist | Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months. |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Whole Health STEPS (Structured Tiered Engagement With Peer Support) (Randomized) | Participants in this arm received support from a VA peer specialist to discuss their Whole Health including self-care and professional care goals and progress. | 0 | 21 | 0 | 21 | 1 | 21 |
| EG002 | Waitlist | Participants in this arm received Whole Health STEPS (Structured Tiered Engagement with Peer Support) after approximately 2 months. | 0 | 23 | 0 | 23 | 2 | 23 |
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