Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Study Overview
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Brief Summary
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The objectives of this research study are to screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

Detailed Description
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Studies of Posttraumatic Stress Disorder (PTSD) in pregnant women in public payer settings have shown rates 5 or more times that of other populations, and rates as high as 33% of lifetime PTSD sub-threshold symptoms. PTSD during pregnancy has been linked to poor prenatal care and high risk behaviors such as drug and alcohol use and smoking. Further, PTSD may pose a barrier to care as obstetric procedures and pregnancy may trigger PTSD symptoms and avoidance of care. PTSD is also associated with pregnancy and birth complications and negative postpartum outcomes including excessive weight gain, preterm birth, low birth weight, risk for parenting problems, and increased barriers to breastfeeding. However, screening, identification, and support for PTSD is lacking. This study will screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

Official Title
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Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Adapted Seeking Safety Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers who are receiving prenatal care 18 years or older In the first 20 weeks of pregnancy Screen positive for posttraumatic stress disorder Exclusion Criteria: Not pregnant Not currently psychotic No current suicidal ideation Language other than English, Spanish, Vietnamese, and Portuguese

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions | Behavioral: Adapted Seeking Safety Intervention<br>* Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.<br>|
| No Intervention: No intervention<br>Treatment as usual mothers receive usual services of a prenatal care advocate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in posttraumatic stress disorder symptoms |  | The primary endpoint is one month postpartum | 
| Preterm labor |  | the primary endpoint is one month postpartum | 
| Birthweight |  | the primary endpoint is one month postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of visits for prenatal care |  | the primary end point is one month postpartum | 
| Change in depression symptoms |  | the primary endpoint is one month postpartum | 
| change in coping strategies inventory |  | the primary endpoint is one month postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress disorder, prenatal care