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OpenTrials
Completed

NCT Number: NCT02807662

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted Seeking Safety Intervention

Behavioral

Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.

Primary outcomes

  1. Change in posttraumatic stress disorder symptoms

    Time frame: The primary endpoint is one month postpartum

  2. Preterm labor

    Time frame: the primary endpoint is one month postpartum

  3. Birthweight

    Time frame: the primary endpoint is one month postpartum

Secondary outcomes

  1. Number of visits for prenatal care

    Time frame: the primary end point is one month postpartum

  2. Change in depression symptoms

    Time frame: the primary endpoint is one month postpartum

  3. change in coping strategies inventory

    Time frame: the primary endpoint is one month postpartum

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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