Improving Mental Healthcare Outcomes for Minoritized Veterans Through a Peer-led, Patient Navigation Program (PARTNER-MH 2.0)

NCT07645274 | Not Yet Recruiting DMC

• 2 other identifiers: HSR2-001-24WI01RD000506-01A2
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed project is a randomized controlled trial that seeks to test the effectiveness of a peer-facilitated, patient navigation program to improve mental healthcare experiences and outcomes for under-supported Veterans from diverse cultural backgrounds and communities. PARTNER-MH is a structured, telehealth-based intervention delivered by VHA peer specialists over a three-month period. It integrates two evidence-based care delivery models, peer support and patient navigation, and addresses three primary contributors to healthcare disparities: unmet social needs, low patient engagement in care, and unproductive patient-clinician communication. Findings from this study will support ongoing efforts to improve mental health services for all Veterans in the VHA.

Conditions

Diagnoses of Depression; Anxiety; PTSD

Keywords

Depression; Anxiety; Post-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• The Veterans RAND 12 Item Health Survey (VR-12), mental health composition score (6-items, MCS)

  The Veterans RAND 12-item (VR-12) is a brief, multi-use, self-administered survey that is used primarily to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". VR-12 scores are standardized using a T-score metric ranging from 1-100, with a mean of 50 and a standard deviation of 10. Scores below 50 indicate worse mental health than the general population average.

  baseline, 3 and 6 months

Secondary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  baseline, 3 and 6 months

• Generalized Anxiety Disorder-7 (GAD-7)

  baseline, 3 and 6 months

• PTSD symptoms -Life Event Checklist (PCL-5)

  baseline, 3 and 6 months

• Altarum Consumer Engagement (ACE) scale

  baseline, 3 and 6 months

• Perceived Efficacy in Patient-Physician Interaction scale (PEPPI-5)

  baseline, 3 and 6 months

Other Outcomes (3)

• Working Alliance Inventory Short-Revised (WAI-SR)

  baseline, 3 and 6 months

• Multi-Dimensional Treatment Satisfaction Measure (MDSTM)

  baseline, 3 and 6 months

• Assessing Circumstances and Offering Resources for Needs (ACORN)

  baseline, 3 and 6 months

Study Arms (2)

Intervention condition

EXPERIMENTAL

Arm 1 involves delivery of the study intervention, PARTNER-MH program.

Behavioral: PARTNER-MH

Control condition

ACTIVE COMPARATOR

Participants in this arm will receive the control condition, which consists of informational/education materials.

Behavioral: Educational Brochure

Interventions

Educational Brochure BEHAVIORAL

The control condition consists of informational/educational materials that will be distributed to study participants after randomization and completion of baseline assessment. The content of the educational brochure includes 3-4 brief, healthy living articles about stress management, well-being, and navigation of health services.

Control condition

PARTNER-MH BEHAVIORAL

PARTNER-MH is a manualized, peer-facilitated, patient navigation intervention that involves the delivery of three services: 1) peer support to increase patient engagement in care, 2) patient navigation to address unmet social needs and increase access to services, and 3) psychoeducation to increase communication self-efficacy. PARTNER-MH consists of 10 sessions, lasting up to 60 minutes, that will be delivered over 12 weeks via videoconference or phone. It also includes a rapport building/orientation session that will be delivered in person or via videoconference to facilitate study engagement and two flex weeks with no scheduled lessons to accommodate rescheduling if needed.

Intervention condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of a racial or ethnic minoritized group
• Veterans who are currently receiving or waiting to receive treatment in the outpatient mental health clinics or affiliated CBOCS at the study sites
• Eligible participants must be:
• waiting to start treatment (e.g., Veterans who were referred to treatment, assigned a provider, or recommended a treatment option that includes either pharmacotherapy, psychotherapy, or both but have not yet started treatment at time of enrollment)
• Veterans who are already receiving ongoing treatment - pharmacotherapy, individual, and/or group psychotherapy, but initiated treatment within 9 months of study enrollment date
• Have a diagnosis of depression, anxiety, or PTSD
• Not currently receiving peer services in the outpatient clinic

You may not qualify if:

• Patients needing emergency psychiatric services of hospitalization due to suicidal ideation or recent suicide attempt (within past 2 months), have severe psychiatric symptoms (e.g., active psychosis), or a diagnosis of severe mental illness (e.g., schizophrenia)
• Severe cognitive, hearing, or speech impairment (e.g., dementia, severe TBI)
• Severe physical illness that impedes study participation
• Recent hospitalization for substance use disorder (SUD) for the past 2 months or severe SUD symptoms based on the screen tools (AUDIC-C, DAST-10) that may require higher level of care and peer support

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Indiana University: collaborator
• VA Pittsburgh Healthcare System: collaborator
• White River Junction Veterans Affairs Medical Center: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (2)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Johanne Eliacin, PhD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanne Eliacin, PhD

CONTACT

(317) 988-5298; johanne.eliacin@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be masked to participants' assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two study conditions.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): September 28, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)