Perinatal AnxietyNCT07880457
Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
A study testing Patient Navigation (PN) and Problem Solving Therapy (PST) in people with Perinatal Anxiety and Perinatal Depression, run by American University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an intervention can improve mental health outcomes among pregnant and postpartum Latinas. The main questions it answers are: Is a collaborative, community health worker and social worker intervention is feasible within a community health setting? Is a collaborative… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Anxiety, Perinatal Depression
- What is being tested?
- Patient Navigation (PN) and Problem Solving Therapy (PST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Sep 2027
- Phase
- Interventional
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant
- Identify as Hispanic or Latina
- Receive social services from El Buen Samaritano and/or obstetric services from LoneStar Circle of Care
- Between 20- and 32-weeks' gestation
- 18 years or older
- Screen positive for depression or anxiety (PHQ-4≥3 on either subscale)
Who cannot join
- Not pregnant
- Do not identify as Hispanic or Latina
- Do not receive services at El Buen Samaritano or LoneStar Circle of Care
- Before 20 weeks pregnant or after 32 weeks pregnant
- Under 18
- Do not screen positive for depression or anxiety
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
El Buen Samaritano
Austin, Texas, 78745
Rosamaria Murillo, PhD, LMSW, 512-439-8900, communications@elbuen.org
About this study
Official title: Improving Perinatal Mental Health Among Latinas Through a Culturally Adapted, Multi-Level Intervention
The goal of this clinical trial is to learn if an intervention can improve mental health outcomes among pregnant and postpartum Latinas. The main questions it answers are:
Is a collaborative, community health worker and social worker intervention is feasible within a community health setting? Is a collaborative, community health worker and social worker intervention is acceptable among Latina individuals in Central Texas? Do participants experience an improvement in perinatal mental health outcomes during or after the collaborative intervention?
Read more
Participants will:
- Receive 3 community health worker and social worker sessions during pregnancy.
- Receive 3 community health worker and social worker sessions postpartum (up to 12 weeks).
- Complete a survey at three timepoints (baseline, 2 weeks postpartum and 12 weeks postpartum).
- Conditions
- Perinatal Anxiety, Perinatal Depression
- Being tested
- Patient Navigation (PN), Problem Solving Therapy (PST)
- Keywords
- perinatal, mental health, community health worker, social worker, Latina
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation (PN)Behavioural
Patient navigation (PN) is an evidence-based intervention that removes barriers to healthcare services. PN typically supports patients by identifying healthcare services and addressing any access barriers such as location, cost, or transportation.
Problem Solving Therapy (PST)Behavioural
Problem solving therapy (PST) is an evidence-based, mental health intervention that consists of cognitive behavioral and problem-solving strategies aimed at improving mental health.
| Study group | Role | What they receive |
|---|---|---|
| CHW+SW intervention | Experimental | Community health workers (CHWs) will provide patient navigation to assess and address health related social needs, while social worker (SWs) will focus on mental health needs, and provide a standardized, PST intervention. Receives: Behavioral: Patient Navigation (PN); Behavioral: Problem Solving Therapy (PST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment
Feasibility will be assessed based on recruitment metrics, which includes the number and percent of patients screened and enrolled per week.
Measured: From enrollment until we reach 45 participants (Up to 24 weeks)
Feasibility- Attrition
Feasibility will be assessed based on attrition, or the proportion of participants who withdraw from the study before its completion.It will be calculated as the number of participants lost to follow-up divided by the total number initially enrolled.
Measured: From enrollment until at least 30 participants complete the study (Up to 24 weeks)
Feasibility- Retention
Feasibility will be assessed based on retention, or the proportion of participants who remain in the study through to its conclusion.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Feasibility- Completion of Intervention
Feasibility will be assessed based on number of participants who complete of Intervention, which is the percentage of participants who receive the "full dose" or intended components of the intervention.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Feasibility- Duration
Feasibility will be assessed based on duration, or the average amount of time required to complete the intervention per participant.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Feasibility- Completion of Study Assessments
Feasibility will be assessed based on completion of study assessments. This will be defined as the proportion of participants who complete required data collection activities at each timepoint.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Acceptability
Acceptability will be assessed based on patient satisfaction, retention, and qualitative interviews.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Secondary outcomes (6)
Depression: Edinburgh Postpartum Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire designed to screen for symptoms of depression during the perinatal period. The Edinburgh Postnatal Depression Scale (EPDS) has been validated for use with Latina populations, with studies showing a Spanish version performs adequately.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Anxiety: Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale used to screen for and assess the severity of generalized anxiety disorder. The GAD-7 has been validated in both general and perinatal populations, demonstrating strong psychometric properties, including good reliability and construct validity.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Post-traumatic stress disorder: Impact of Event Scale-6
The Impact of Event Scale-6 (IES-6) is a brief, 6-item self-report measure used to assess post-traumatic stress symptoms in response to a specific stressful or traumatic event. The IES-6 has demonstrated strong reliability and validity in perinatal populations, including women who have experienced traumatic birth or pregnancy complications.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Health related social needs: PhenX
The PhenX Toolkit is a publicly available resource that provides standardized, consensus-based measures for use in biomedical and public health research. It includes a wide range of validated instruments to measure health related social needs. For example, the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE) is a nationally recognized, evidence-informed tool designed to assess social determinants of health in clinical and community settings. The PRAPARE tool has been widely used and validated in diverse populations, including Latina communities, and is available in Spanish.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Respectful Care: MADM
The Mothers' Autonomy in Decision Making (MADM) scale is a 7-item, validated self-report measure that evaluates the extent to which individuals feel they were supported to make informed decisions about their maternity care. MADM has been validated with perinatal and Latina populations.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Respectful Care: MORi
The Mothers on Respect Index (MORi) is a 14-item measure that assesses the degree of respectful, dignified, and non-coercive care received during maternity care. MORi has been validated with perinatal and Latina populations.
Measured: From enrollment to the end of the study at 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Community Health Workers will implement patient navigation (PN), which is an evidence-based intervention that removes barriers to healthcare services for underserved populations. Social workers will implement problem solving therapy (PST), which is an evidence-based, mental health intervention that consists of cognitive behavioral and problem-solving strategies aimed at improving mental health.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Liana Petruzzi, American University
- Investigators
- Liana Petruzzi, PhD, LCSW, Principal investigator, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880457
- Sponsor's protocol ID
- IRB-2025-33
- Other IDs
- K01MD019724
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that is shared will be aggregated and deidentified. Access to this data will require PI permission that will include conditions for using the data such as time limitations and co-authorship.