Posttraumatic Stress DisorderNCT02807662
Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
A study testing Adapted Seeking Safety Intervention in people with Posttraumatic Stress Disorder, run by University of Massachusetts, Worcester.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Adapted Seeking Safety Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mothers who are receiving prenatal care
- 18 years or older
- In the first 20 weeks of pregnancy
- Screen positive for posttraumatic stress disorder
Who cannot join
- Not pregnant
- Not currently psychotic
- No current suicidal ideation
- Language other than English, Spanish, Vietnamese, and Portuguese
About this study
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.
Read the 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
- Being tested
- Adapted Seeking Safety Intervention
- Keywords
- posttraumatic stress disorder, prenatal care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Seeking Safety InterventionBehavioural
Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions Receives: Behavioral: Adapted Seeking Safety Intervention |
| No intervention | No intervention | Treatment as usual mothers receive usual services of a prenatal care advocate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in posttraumatic stress disorder symptoms
Measured: The primary endpoint is one month postpartum
Preterm labor
Measured: the primary endpoint is one month postpartum
Birthweight
Measured: the primary endpoint is one month postpartum
Secondary outcomes (3)
Number of visits for prenatal care
Measured: the primary end point is one month postpartum
Change in depression symptoms
Measured: the primary endpoint is one month postpartum
change in coping strategies inventory
Measured: the primary endpoint is one month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startFeb 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Linda Weinreb, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807662
- Sponsor's protocol ID
- 1 R40MC23633-01-00
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37146219Weinreb 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.
PubMed 29116416
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
- ClinicalTrials.gov ID
- NCT02807662
- Acronym / sponsor ID
- 1 R40MC23633-01-00
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder, prenatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Adapted Seeking Safety InterventionIntervention mothers receive adapted Seeking Safety intervention delivered by prenatal care advocate over 8 sessions |
| No intervention | No intervention | –Treatment as usual mothers receive usual services of a prenatal care advocate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers who are receiving prenatal care
- 18 years or older
- In the first 20 weeks of pregnancy
- Screen positive for posttraumatic stress disorder
Key exclusion criteria (4 listed)
- Not pregnant
- Not currently psychotic
- No current suicidal ideation
- Language other than English, Spanish, Vietnamese, and Portuguese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Seeking Safety InterventionIntervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting. | Behavioural | Experimental |
Primary outcome
Change in posttraumatic stress disorder symptoms
Time frame: The primary endpoint is one month postpartum
Preterm labor
Time frame: the primary endpoint is one month postpartum
Birthweight
Time frame: the primary endpoint is one month postpartum
3 secondary outcomes
Number of visits for prenatal care
Time frame: the primary end point is one month postpartum
Change in depression symptoms
Time frame: the primary endpoint is one month postpartum
change in coping strategies inventory
Time frame: the primary endpoint is one month postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Derived from this study: PubMed 37146219Jones 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.
- Derived from this study: PubMed 29116416Weinreb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Seeking Safety Intervention in people with Posttraumatic Stress Disorder, run by University of Massachusetts, Worcester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in posttraumatic stress disorder symptoms (time frame: The primary endpoint is one month postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.