Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992767
• Other study ID #: 2021-0002
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: University of Illinois at Chicago
• Contact: Erin Berenz, PhD
• Phone: (312) 355-0808
• Email: eberenz[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Pregnancy Related
• Stress Disorders, Post-Traumatic

Intervention

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.
• SunnysideFlex
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

Locations

Country	Name	City	State
United States	University of Illinois Department of Psychology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Past 30 days
Primary	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	1 week
Primary	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.	2 weeks