Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Adapted Seeking Safety Intervention

• Registration Number: NCT02807662
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Study First Posted: 2016-06-21
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Adapted Seeking Safety Intervention	Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions

Primary Outcome Measures

Name	Time	Method
Preterm labor	the primary endpoint is one month postpartum
Change in posttraumatic stress disorder symptoms	The primary endpoint is one month postpartum
Birthweight	the primary endpoint is one month postpartum

Secondary Outcome Measures

Name	Time	Method
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