Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Pregnancy Related

• Registration Number: NCT04992767
• Lead Sponsor: University of Illinois at Chicago

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Study Start: 2022-10-21
• Primary Completion: 2024-04-19
• Study Completion: 2024-10-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of Events Scale - Revised (IES-R)	1 week	The IES-R assesses the past-week frequency of PTSD symptoms in reference to the participant's self-identified worst traumatic event
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.

Trial Locations

Locations (1)

University of Illinois Department of Psychology; 🇺🇸 Chicago, Illinois, United States