Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
1 other identifier
interventional
149
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedJune 21, 2016
June 1, 2016
3.3 years
June 14, 2016
June 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in posttraumatic stress disorder symptoms
The primary endpoint is one month postpartum
Preterm labor
the primary endpoint is one month postpartum
Birthweight
the primary endpoint is one month postpartum
Secondary Outcomes (3)
Number of visits for prenatal care
the primary end point is one month postpartum
Change in depression symptoms
the primary endpoint is one month postpartum
change in coping strategies inventory
the primary endpoint is one month postpartum
Study Arms (2)
Experimental
EXPERIMENTALIntervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions
No intervention
NO INTERVENTIONTreatment as usual mothers receive usual services of a prenatal care advocate
Interventions
Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.
Eligibility Criteria
You may qualify if:
- Mothers who are receiving prenatal care
- years or older
- In the first 20 weeks of pregnancy
- Screen positive for posttraumatic stress disorder
You may not qualify if:
- Not pregnant
- Not currently psychotic
- No current suicidal ideation
- Language other than English, Spanish, Vietnamese, and Portuguese
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 37146219DERIVEDWeinreb 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.
PMID: 29116416DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 21, 2016
Study Start
February 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 21, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share