Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Pregnancy Related
• Interventions: Behavioral: SunnysideFlex; Behavioral: Sunnyside

• 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

Arm && Interventions

Group	Intervention	Description
SunnysideFlex	SunnysideFlex	An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy.
Sunnyside	Sunnyside	An online intervention to better manage mood during and after pregnancy.

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