Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

• Sponsor: University of Massachusetts, Worcester (Other)
• Overall Status: Completed
• CT.gov ID: NCT02807662
• Collaborator: Health Resources and Services Administration (HRSA) (U.S. Fed)
• Enrollment: 149
• Arms: 2
• Duration (Months): 40

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Behavioral: Adapted Seeking Safety Intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions	Behavioral: Adapted Seeking Safety Intervention; Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.
No Intervention: No intervention Treatment as usual mothers receive usual services of a prenatal care advocate

Outcome Measures

Primary Outcome Measures

1. Change in posttraumatic stress disorder symptoms [The primary endpoint is one month postpartum]

2. Preterm labor [the primary endpoint is one month postpartum]

3. Birthweight [the primary endpoint is one month postpartum]

Secondary Outcome Measures

1. Number of visits for prenatal care [the primary end point is one month postpartum]

2. Change in depression symptoms [the primary endpoint is one month postpartum]

3. change in coping strategies inventory [the primary endpoint is one month postpartum]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Massachusetts, Worcester
• Health Resources and Services Administration (HRSA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Linda Weinreb, Principal Investigator, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT02807662
• Other Study ID Numbers: 1 R40MC23633-01-00
• First Posted: Jun 21, 2016
• Last Update Posted: Jun 21, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Linda Weinreb, Principal Investigator, University of Massachusetts, Worcester: posttraumatic stress disorder; prenatal care
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jun 21, 2016