Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
Study Details
Study Description
Brief Summary
The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. SunnysideFlex will build upon the previously tested "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 16-28 of their pregnancy who self-report symptoms of PTSD will be randomized to receive either SunnysideFlex or Sunnyside. The Sunnyside intervention will consist of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. SunnysideFlex will include an additional 2 weeks of trauma-informed online lessons during pregnancy, for a total of 8 consecutive weeks of online intervention during pregnancy, as well as booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. SunnysideFlex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.
| Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sunnyside An online intervention to better manage mood during and after pregnancy. |
Behavioral: Sunnyside
The Sunnyside intervention is an online intervention(an interactive website with didactic material and interactive tools) targeting skills to manage mood during and after pregnancy. The Sunnyside intervention will consist of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Each lesson takes approximately 10 minutes to complete.
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| Experimental: SunnysideFlex An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy. |
Behavioral: SunnysideFlex
SunnysideFlex consists of 8 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. SunnysideFlex builds upon the same Sunnyside intervention by providing the original 6-week Sunnyside program (described above), followed by an additional 2 weeks of trauma-specific prenatal intervention designed to reduce symptoms of PTSD, using evidence-based content that has been tailored specifically to the perinatal period.
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Outcome Measures
Primary Outcome Measures
- PTSD Checklist for DSM-5 (PCL-5) [Past 30 days]
The PCL-5 is a well validated screening tool for assessing PTSD symptoms and probable PTSD diagnosis. the PCL-5 checklist assesses frequency of past 30-day PTSD symptoms in reference to an individual's self-identified worst traumatic event. A total score of 33 or greater represents a positive PTSD screen and is the cut-off employed in the current study.
- Patient Health Questionnaire-9 (PHQ-9) [2 weeks]
Reflects overall functioning and impairment due to the depressive symptoms. PHQ-9 scoring interpretations are as follows: 1-4: minimal depressive symptoms; 5-9 mild depressive symptoms; 10-14: moderate depressive symptoms; 15-19: moderately severe depressive symptoms: 20-27: severe depressive symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female
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18 years and older
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Pregnant and between 16-28 weeks gestation
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Endorse a history of one or more potentially traumatic events meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Criterion A for PTSD (i.e., "exposure to actual or threatened death, serious injury, or sexual violence," American Psychological Association [APA], p. 271) that is interpersonal in nature (e.g., sexual or physical assault, child abuse/maltreatment, witnessing family violence)
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Endorse a score of 33 or greater on the PTSD Checklist for DSM-5 (PCL-5);
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Have access to a broadband internet connection
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Able to read and speak English
Exclusion Criteria:
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Pregnant with multiples
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Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
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Have been diagnosed with a major depressive episode, psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report
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Report currently being in an abusive or unsafe relationship
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Currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Erin C Berenz, PhD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-0002