Perinatal Peer Support for Veterans With Serious Mental Illness

VA Office of Research and Development

Status: Begins enrollment in a year or more

Conditions: Persons With Psychiatric Disorders

Treatments: Behavioral: Perinatal peer support

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07362576

HSR5-008-24W

CDX 25-003 (Other Grant/Funding Number)

IK2RD000606-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Usual care plus perinatal peer support

Experimental group

Description:

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.

Treatment:

Behavioral: Perinatal peer support

Usual care

No Intervention group

Description:

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.