Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

NCT ID: NCT02807662

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-06-30

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions

Group Type: EXPERIMENTAL

Adapted Seeking Safety Intervention

Intervention Type: BEHAVIORAL

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

No intervention

Treatment as usual mothers receive usual services of a prenatal care advocate

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adapted Seeking Safety Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Linda Weinreb

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

Reference Type: DERIVED

PMID: 37146219 (View on PubMed)

Weinreb L, Wenz-Gross M, Upshur C. Postpartum outcomes of a pilot prenatal care-based psychosocial intervention for PTSD during pregnancy. Arch Womens Ment Health. 2018 Jun;21(3):299-312. doi: 10.1007/s00737-017-0794-x. Epub 2017 Nov 7.

Reference Type: DERIVED

PMID: 29116416 (View on PubMed)

Other Identifiers

1 R40MC23633-01-00

Identifier Type: -

Identifier Source: org_study_id