Perinatal Peer Support for Veterans With Serious Mental Illness

Improving the Perinatal Mental Health of Veterans With Serious Mental Illness Through Peer Support

Veterans with serious mental illness (SMI) are at high risk of exacerbation of mental illness in pregnancy and postpartum, with consequences including poor pregnancy outcomes, decreased functioning, and impaired child development. Peer support could play a key role in supporting pregnant and postpartum Veterans with SMI. In this study, investigators will develop (Aims 1 and 2) and pilot (Aim 3) a peer specialist-delivered perinatal mental health intervention for Veterans with SMI, drawing from evidence-based models and input from Veterans, key VA clinical staff, and subject matter experts. The intervention will be piloted to assess its feasibility and acceptability, as well as exploratory clinical outcomes including postpartum functioning and mental health symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Persons With Psychiatric Disorders
• Intervention / Treatment: Behavioral: Perinatal peer support

Detailed Description

There are currently no perinatal mental health interventions designed for or tested among Veterans with SMI. Reach Out, Stay Strong Essentials (ROSE)-a five-session evidence-based psychosocial intervention for prevention of postpartum depression in women without mental illness-is currently being implemented in the VA health care system. To date, ROSE implementers have noted the benefits of the intervention for pregnant Veterans, but have also shared its shortcomings for those with SMI, including its limited attention to current psychiatric symptoms, limited postpartum support, and minimal content related to unmet social or clinical needs.

Peer support-offered by individuals with lived experience of mental illness-is emerging as a key component of VA mental health care, and recent Congressional mandates call for expansion of VA peer support services for women. Perinatal peer support has been shown to improve mental health outcomes in non-SMI populations, but there have been no studies of its effects in women with SMI or Veterans. To address these gaps, the investigators will develop and pilot an adapted, peer specialist-delivered perinatal mental health intervention for Veterans with SMI, blending ROSE with components from evidence-based perinatal and SMI peer support models, and tailored to perinatal Veterans' unique needs and the VA context.

Guided by the Transcreation Framework, an implementation science framework for community-partnered development of behavioral interventions for vulnerable populations, the Specific Aims are to:

Aim 1. Engage Veterans and key VA clinical staff in identifying potential components of a tailored peer support intervention for perinatal Veterans with SMI. Individual semi-structured interviews with pregnant and postpartum Veterans with SMI and VA women's mental health providers will assess the experiences, needs, and care preferences of perinatal Veterans with SMI, as well as desirable intervention components of existing perinatal and peer support interventions. Focus groups with VA Maternity Care Coordinators and women VA peer specialists will also explore intervention components and implementation considerations.

Aim 2. Develop and refine the intervention. Using Delphi methodology, the investigators will present potential intervention components-drawn from ROSE and existing peer support interventions, and accompanied by relevant data from the literature and Aim 1 findings-to an expert panel of VA multilevel constituents to identify final components as well as adaptations to optimize fit to the target population and VA women's health settings. The investigators will then develop the intervention prototype and materials in an iterative process in collaboration with operations partners, women Veteran peer specialists, and mentors.

Aim 3. Assess the feasibility, acceptability, and exploratory outcomes of the intervention in a pilot study. This single-site feasibility pilot will include approximately 24 Veterans with SMI enrolled during pregnancy and engaged through approximately 3 months postpartum, randomized to perinatal peer support or usual care. Mixed methods evaluation will focus on feasibility and acceptability, as well as exploratory clinical (e.g., depression) and service utilization outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nichole I Goodsmith, MD PhD; Phone Number: 41298 (310) 478-3711; Email: Nichole.Goodsmith@va.gov
• Study Contact Backup: Name: Kristina M Cordasco, MD MPH MSHS; Phone Number: 40921 (310) 478-3711; Email: Kristina.Cordasco@va.gov

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073-1003
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
      • Contact: Elizabeth M Yano, PhD MSPH; Phone Number: 36031 818-891-7711; Email: Elizabeth.Yano@va.gov
      • Contact: David A Ganz, MD PhD MPH; Phone Number: 40515 (310) 478-3711; Email: David.Ganz@va.gov
      • Principal Investigator: Nichole I Goodsmith, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pregnant Veterans with serious mental illness

  • a diagnosis of major depressive disorder
  • PTSD
  • bipolar disorder
  • schizophrenia
  • other psychotic disorder

Exclusion Criteria:

• Participants will be enrolled in the outpatient setting, and therefore will not be eligible to enroll while admitted to an inpatient psychiatric unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual care plus perinatal peer support; Participants in this arm will receive the perinatal peer support intervention, delivered by a trained Veteran perinatal peer specialist. They will continue to have access to routinely offered mental health and health services, including but not limited to Maternity Care Coordination, psychiatry, psychotherapy, and/or social work.	Behavioral: Perinatal peer support; The final intervention model, components, and timeline will be determined in an iterative process incorporating scientific evidence with input from Veterans, staff, and leadership in Aims 1 and 2. Preliminarily, the intervention is anticipated to begin with perinatal peer specialist contact by week 32 of pregnancy and continue for a duration of ~6 months. Session content may include psychoeducation and assessment of functional goals (e.g., related to employment, relationships, or illness management) and unmet social needs (e.g., housing, childcare, financial). Given that the initial postpartum period is a time of increased need for social support and vulnerability to mental health decline, peer support contact will continue until approximately 3 months postpartum.
No Intervention: Usual care; Usual care will include access to routinely offered mental health and health services, including but not limited to Maternity Care Coordination, psychiatry, psychotherapy, and/or social work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment and retention	Feasibility of recruitment procedures will be assessed by the percent of eligible Veterans who enroll, and cited reasons for declined participation. Feasibility of retention will be assessed by percent of enrolled participants completing the post-intervention assessment, and cited reasons for study termination or non-completion.	up to 9 months
8-item Client Satisfaction Questionnaire (CSQ-8)	The CSQ-8 will be used to assess acceptability of the intervention to participants. Scores range from 8 to 32, with higher values indicating higher satisfaction.	within 2 months of intervention completion
Participant and provider perspectives	Qualitative assessment of intervention acceptability, feasibility, and appropriateness will be accomplished through semi-structured post-intervention interviews with participants, peer specialists, and adjacent staff (women's mental health providers, maternity care coordinators).	within 2 months of intervention completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barkin Index of Maternal Functioning (BIMF)	Postpartum functional status will be assessed using the 20-item BIMF.	up to 9 months
24-item Behavior and Symptom Identification Scale (BASIS-24)	The BASIS-24 is a widely used, validated instrument capturing degree of distress or impairment, overall and on six subscales (Depression/Functioning, Relationships, Self-Harm, Emotional Lability, Psychosis, and Substance Abuse).	up to 9 months
Edinburgh Postnatal Depression Scale (EPDS)	The EDPS is a 10-item depression screening tool, validated for use in both pregnancy and postpartum.	up to 9 months
Perinatal Anxiety Screening Scale (PASS)	The 31-item PASS is a validated tool for anxiety screening in pregnancy and postpartum.	up to 9 months
5-item Primary Care PTSD screen for DSM-5 (PC-PTSD-5)	The PC-PTSD-5 is a brief screening tool to identify posttraumatic stress disorder symptom severity.	up to 9 months
American Academy of Family Physicians (AAFP) Social Needs Screening Tool	Social needs will be assessed with the 14-item American Academy of Family Physicians (AAFP) Social Needs Screening Tool, which includes a range of social determinants of health (housing, food, transportation, utilities, childcare, employment, education, finances, and personal safety).	up to 9 months
Recovery Assessment Scale (RAS)	Recovery will be measured with the 24-item RAS, a validated tool studied extensively in populations with serious mental illness, which assesses five factors of recovery (personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms).	up to 9 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Nichole I Goodsmith, MD PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2028
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Veterans Health; Pregnant Women; Peer Support; Postpartum Care
• Other Study ID Numbers: HSR5-008-24W; CDX 25-003 (Other Grant/Funding Number: VA HSR); IK2RD000606-01A1 (Other Grant/Funding Number: VA ORD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No