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| ID | Type | Description | Link |
|---|---|---|---|
| CDX 25-003 | Other Grant/Funding Number | VA HSR | |
| IK2RD000606-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care plus perinatal peer support | Experimental | 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. |
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| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perinatal peer support | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
pregnant Veterans with serious mental illness
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nichole I Goodsmith, MD PhD | Contact | (310) 478-3711 | 41298 | Nichole.Goodsmith@va.gov |
| Kristina M Cordasco, MD MPH MSHS | Contact | (310) 478-3711 | 40921 | Kristina.Cordasco@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Nichole I Goodsmith, MD PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | United States |
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A feasibility pilot with Veterans with serious mental illness (n=24) enrolled during pregnancy and engaged through approximately 3 months postpartum, randomized to the perinatal peer support intervention or usual care.
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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 |