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Not yet recruiting NCT07362576

Perinatal Peer Support for Veterans With Serious Mental Illness

No phase Interventional Persons With Psychiatric Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perinatal peer support.
Who it may be relevant to
Registry conditions: Persons With Psychiatric Disorders. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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 manage

Primary outcome measures

  • Feasibility of recruitment and retention [Time frame: up to 9 months]
  • 8-item Client Satisfaction Questionnaire (CSQ-8) [Time frame: within 2 months of intervention completion]
  • Participant and provider perspectives [Time frame: within 2 months of intervention completion]
Secondary outcome measures (7)
  • Barkin Index of Maternal Functioning (BIMF) [Time frame: up to 9 months]
  • 24-item Behavior and Symptom Identification Scale (BASIS-24) [Time frame: up to 9 months]
  • Edinburgh Postnatal Depression Scale (EPDS) [Time frame: up to 9 months]
  • Perinatal Anxiety Screening Scale (PASS) [Time frame: up to 9 months]
  • 5-item Primary Care PTSD screen for DSM-5 (PC-PTSD-5) [Time frame: up to 9 months]
  • American Academy of Family Physicians (AAFP) Social Needs Screening Tool [Time frame: up to 9 months]
  • Recovery Assessment Scale (RAS) [Time frame: up to 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles

Identifiers

NCT: NCT07362576 · HSR5-008-24W · CDX 25-003 · IK2RD000606-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗