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PI changed institutions and was no longer able to continue project.
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| Name | Class |
|---|---|
| MUSC Specialized Center of Research Excellence | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD Psychoeducation + Skills Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTSD Psychoeducation + Skills Intervention | Behavioral | A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline to birth of baby. |
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Inclusion Criteria:
Exclusion Criteria:
Intervention for pregnant women, so only women can be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011644 | Puerperal Disorders |
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Open Label Pilot Trial (no control group)
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| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |