An interventional study of Sunnyside and SunnysideFlex in Posttraumatic Stress Disorder and Pregnancy Related, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
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 IRB-approved "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 one of three study groups: (1) SunnysideFlex, (2) the original Sunnyside intervention (active control), or (3) treatment as usual (TAU). The SunnysideFlex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and 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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 1,856 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An online intervention to better manage mood during and after pregnancy.
Behavioral: Sunnyside
An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy.
Behavioral: SunnysideFlex
A control condition consisting of standard prenatal medical care, without provision of the SunnysideFlex or Sunnyside intervention
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.
SunnysideFlex consists of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. SunnysideFlex has adapted the original Sunnyside intervention with revised, trauma-focused content that covers the impact of PTSD symptoms on the perinatal period and daily functioning, more broadly
PTSD Checklist for DSM-5 (PCL-5)
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.
Time frame: Past 30 days
Impact of Events Scale - Revised (IES-R)
The IES-R assesses the past-week frequency of PTSD symptoms in reference to the participant's self-identified worst traumatic event
Time frame: 1 week
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic→
University of Illinois at Chicago