Persons With Psychiatric DisordersNCT07362576
Perinatal Peer Support for Veterans With Serious Mental Illness
A study testing Perinatal peer support in people with Persons With Psychiatric Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Persons With Psychiatric Disorders
- What is being tested?
- Perinatal peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2028to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pregnant Veterans with serious mental illness
- a diagnosis of major depressive disorder
- PTSD
- bipolar disorder
- schizophrenia
- other psychotic disorder
Who cannot join
- Participants will be enrolled in the outpatient setting, and therefore will not be eligible to enroll while admitted to an inpatient psychiatric unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Elizabeth M Yano, PhD MSPH, 818-891-7711 ext. 36031, Elizabeth.Yano@va.gov
David A Ganz, MD PhD MPH, (310) 478-3711 ext. 40515, David.Ganz@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Persons With Psychiatric Disorders
- Being tested
- Perinatal peer support
- Keywords
- Pregnant Women, Peer Support, Postpartum Care, Veterans Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal peer supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Perinatal peer support |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: within 2 months of intervention completion
Secondary outcomes (7)
Barkin Index of Maternal Functioning (BIMF)
Postpartum functional status will be assessed using the 20-item BIMF.
Measured: 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).
Measured: 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.
Measured: up to 9 months
Perinatal Anxiety Screening Scale (PASS)
The 31-item PASS is a validated tool for anxiety screening in pregnancy and postpartum.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jul 2028 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persons With Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nichole I Goodsmith, MD PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362576
- Sponsor's protocol ID
- HSR5-008-24W
- Other IDs
- CDX 25-003, IK2RD000606-01A1
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Perinatal Mental Health of Veterans With Serious Mental Illness Through Peer Support
- ClinicalTrials.gov ID
- NCT07362576
- Acronym / sponsor ID
- HSR5-008-24W
- Conditions
- Persons With Psychiatric Disorders
- Keywords
- Pregnant Women, Peer Support, Postpartum Care, Veterans Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2028 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care plus perinatal peer support | Experimental | Behavioral: Perinatal peer supportParticipants 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- pregnant Veterans with serious mental illness
Key exclusion criteria (1 listed)
- Participants will be enrolled in the outpatient setting, and therefore will not be eligible to enroll while admitted to an inpatient psychiatric unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perinatal peer supportThe 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. | Behavioural | Usual care plus perinatal peer support |
Primary outcome
Feasibility of recruitment and retention
Time frame: 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)
Time frame: 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
Time frame: 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).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nichole I Goodsmith, MD PhD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal peer support in people with Persons With Psychiatric Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nichole I Goodsmith, MD PhD ((310) 478-3711 ext. 41298, Nichole.Goodsmith@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment and retention (time frame: up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.