RECRUITING
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Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
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.
Conditions:
🦠 Posttraumatic Stress Disorder 🦠 Pregnancy Related
🗓️ Study Start (Actual) 21 October 2022
🗓️ Primary Completion (Estimated) June 2023
✅ Study Completion (Estimated) December 2023
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female
    • * 18 years and older
    • * Pregnant and between 16-28 weeks gestation
    • * Are currently engaged in prenatal care with a healthcare provider (OB/GYN, nurse, midwife, etc.)
    • * 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)
    • * Endorse a score of 33 or greater on the PTSD Checklist for DSM-5 (PCL-5)
    • * Have access to a broadband internet connection
    • * Able to read and speak English

    Exclusion Criteria:

    • * Pregnant with multiples
    • * Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
    • * Have been diagnosed with a 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
    • * Report currently being in an abusive or unsafe relationship
    • * 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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 July 2021
  • First Submitted that Met QC Criteria 28 July 2021
  • First Posted 5 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 October 2022
  • Last Update Posted 2 November 2022
  • Last Verified October 2022
I'm interested ...!!