Mental Health
Conditions
Keywords
Primary Health Care, Mental Health
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.
Interventions
BEHAVIORALWhole Health STEPS
A peer-delivered package of Whole Health services.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study compares Whole Health STEPS to a waitlist control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inventory of Psychosocial Functioning (IPF) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily M. Johnson, PhD
Syracuse VA Medical Center, Syracuse, NY
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.36 Years STANDARD_DEVIATION 9.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Positive Anxiety Screening on the Generalized Anxiety Disorder-7 (GAD-7) | 5 Participants |
| Positive Depression Screening on the Personal Health Questionnaire-9 (PHQ-9) | 11 Participants |
| Positive Hazardous Alcohol Use Screening Alcohol Use Disorders Identification Test (AUDIT) | 7 Participants |
| Positive Post-Traumatic Stress Disorder (PTSD) Screening on the PTSD Checklist for DSM-5 (PCL-5) | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 21 | 0 / 23 |
| other Total, other adverse events | 0 / 11 | 1 / 21 | 2 / 23 |
| serious Total, serious adverse events | 0 / 11 | 0 / 21 | 0 / 23 |
Outcome results
None listed