Perinatal ProblemsNCT04264520
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
A study testing PTSD Psychoeducation + Skills Intervention in people with Perinatal Problems and Post Traumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Perinatal Problems, Post Traumatic Stress Disorder, Post Partum Depression
- What is being tested?
- PTSD Psychoeducation + Skills Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 23 Apr 2021
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old
- Fluent in English
Who cannot join
- Active and severe domestic violence
- Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention
- Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)
- Women who smoke
- Women who have a metabolic or endocrine disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina Institute of Psychiatry
Charleston, South Carolina, 29425
About this study
The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.
- Being tested
- PTSD Psychoeducation + Skills Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD Psychoeducation + Skills InterventionBehavioural
A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| PTSD Psychoeducation + Skills Intervention | Experimental | Not described Receives: Behavioral: PTSD Psychoeducation + Skills Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5) Total Scores
The PCL-5 is a 17-item self-report questionnaire designed to assess PTSD symptoms among civilians. In the current study, PCL-5 total scores will be utilized. Specifically, we will examine the impact of the intervention on change in PCL-5 scores across time (i.e., from baseline to post-delivery follow-up). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more symptoms.
Measured: Baseline to follow-up (follow-up will occur at one-month following the baby's birth)
Baby's Weight at Birth in Pounds/Ounces
Each baby's weight (in pounds/ounces) will be derived from the online medical record following delivery. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant weight at birth.
Measured: Baseline to birth of baby.
Total Gestation Length in Weeks
The total gestation length, in weeks, will be derived from the online medical record following the baby's birth. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and total weeks gestation at birth.
Measured: Baseline to birth of baby.
Baby's APGAR Score at Birth
Each baby's APGAR score will be derived from the online medical record following delivery. APGAR scores range from 0-10, with higher scores indicating better health at birth for baby. APGAR scores will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant health at birth.
Measured: Baseline to birth of baby.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start5 Jun 2020
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Why it stopped: PI changed institutions and was no longer able to continue project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal ProblemsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Pilot Trial (no control group)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- MUSC Specialized Center of Research Excellence
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264520
- Sponsor's protocol ID
- 00096405
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2020
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
- ClinicalTrials.gov ID
- NCT04264520
- Acronym / sponsor ID
- 00096405
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed institutions and was no longer able to continue project.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- MUSC Specialized Center of Research Excellence
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 11 Feb 2020 (actual)
- 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 current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label Pilot Trial (no control group)
| Arm | Type | Receives |
|---|---|---|
| PTSD Psychoeducation + Skills Intervention | Experimental | Behavioral: PTSD Psychoeducation + Skills Intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 years old
- Fluent in English
Key exclusion criteria (5 listed)
- Active and severe domestic violence
- Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention
- Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)
- Women who smoke
- Women who have a metabolic or endocrine disorder.
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 |
|---|---|---|
| PTSD Psychoeducation + Skills InterventionA brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. | Behavioural | PTSD Psychoeducation + Skills Intervention |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5) Total Scores
Time frame: Baseline to follow-up (follow-up will occur at one-month following the baby's birth)
The PCL-5 is a 17-item self-report questionnaire designed to assess PTSD symptoms among civilians. In the current study, PCL-5 total scores will be utilized. Specifically, we will examine the impact of the intervention on change in PCL-5 scores across time (i.e., from baseline to post-delivery follow-up). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more symptoms.
Baby's Weight at Birth in Pounds/Ounces
Time frame: Baseline to birth of baby.
Each baby's weight (in pounds/ounces) will be derived from the online medical record following delivery. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant weight at birth.
Total Gestation Length in Weeks
Time frame: Baseline to birth of baby.
The total gestation length, in weeks, will be derived from the online medical record following the baby's birth. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and total weeks gestation at birth.
Baby's APGAR Score at Birth
Time frame: Baseline to birth of baby.
Each baby's APGAR score will be derived from the online medical record following delivery. APGAR scores range from 0-10, with higher scores indicating better health at birth for baby. APGAR scores will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant health at birth.
Results and safety
The study was stopped early (reason given: PI changed institutions and was no longer able to continue project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD Psychoeducation + Skills Intervention in people with Perinatal Problems and Post Traumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: PI changed institutions and was no longer able to continue project.). Results are not available in the source record.
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?
PTSD Checklist for DSM-5 (PCL-5) Total Scores (time frame: Baseline to follow-up (follow-up will occur at one-month following the baby's birth)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.