Back to resultsMeeting the Needs of Pregnant Women With PTSD in Prenatal Care
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adapted Seeking Safety Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, prenatal care
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
No intervention
Arm Description
Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions
Treatment as usual mothers receive usual services of a prenatal care advocate
Outcomes
Primary Outcome Measures
Change in posttraumatic stress disorder symptoms
Preterm labor
Birthweight
Secondary Outcome Measures
Number of visits for prenatal care
Change in depression symptoms
change in coping strategies inventory
Full Information
NCT ID
NCT02807662
First Posted
June 14, 2016
Last Updated
June 16, 2016
Sponsor
University of Massachusetts, Worcester
Collaborators
Health Resources and Services Administration (HRSA)
1. Study Identification
Unique Protocol Identification Number
NCT02807662
Brief Title
Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
Official Title
Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Health Resources and Services Administration (HRSA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder, prenatal care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Treatment as usual mothers receive usual services of a prenatal care advocate
Intervention Type
Behavioral
Intervention Name(s)
Adapted Seeking Safety Intervention
Intervention Description
Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.
Primary Outcome Measure Information:
Title
Change in posttraumatic stress disorder symptoms
Time Frame
The primary endpoint is one month postpartum
Title
Preterm labor
Time Frame
the primary endpoint is one month postpartum
Title
Birthweight
Time Frame
the primary endpoint is one month postpartum
Secondary Outcome Measure Information:
Title
Number of visits for prenatal care
Time Frame
the primary end point is one month postpartum
Title
Change in depression symptoms
Time Frame
the primary endpoint is one month postpartum
Title
change in coping strategies inventory
Time Frame
the primary endpoint is one month postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29116416
Citation
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.
Results Reference
derived
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Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
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