Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Posttraumatic Stress Disorder Clinical Trial

Official title:

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807662
• Other study ID #: 1 R40MC23633-01-00
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 16, 2016
• Start date: February 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Adapted Seeking Safety Intervention
Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Health Resources and Services Administration (HRSA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in posttraumatic stress disorder symptoms		The primary endpoint is one month postpartum	No
Primary	Preterm labor		the primary endpoint is one month postpartum	No
Primary	Birthweight		the primary endpoint is one month postpartum	No
Secondary	Number of visits for prenatal care		the primary end point is one month postpartum	No
Secondary	Change in depression symptoms		the primary endpoint is one month postpartum	No
Secondary	change in coping strategies inventory		the primary endpoint is one month postpartum	No