Improving the Perinatal Mental Health of Veterans With Serious Mental Illness Through Peer Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment and retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant Veterans with serious mental illness
- •a diagnosis of major depressive disorder
- •bipolar disorder
- •schizophrenia
- •other psychotic disorder
排除标准
- •Participants will be enrolled in the outpatient setting, and therefore will not be eligible to enroll while admitted to an inpatient psychiatric unit
研究组 & 干预措施
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.
干预措施: Perinatal peer support (Behavioral)
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.
结局指标
主要结局
Feasibility of recruitment and retention
时间窗: up to 9 months
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.
8-item Client Satisfaction Questionnaire (CSQ-8)
时间窗: within 2 months of intervention completion
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.
Participant and provider perspectives
时间窗: within 2 months of intervention completion
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).
次要结局
- Barkin Index of Maternal Functioning (BIMF)(up to 9 months)
- 24-item Behavior and Symptom Identification Scale (BASIS-24)(up to 9 months)
- Edinburgh Postnatal Depression Scale (EPDS)(up to 9 months)
- Perinatal Anxiety Screening Scale (PASS)(up to 9 months)
- 5-item Primary Care PTSD screen for DSM-5 (PC-PTSD-5)(up to 9 months)
- American Academy of Family Physicians (AAFP) Social Needs Screening Tool(up to 9 months)
- Recovery Assessment Scale (RAS)(up to 9 months)