Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

June 16, 2016 updated by: Linda Weinreb, University of Massachusetts, Worcester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

Health Resources and Services Administration (HRSA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 R40MC23633-01-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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