Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

NCT04992767 | Completed

• 1 other identifier: 2021-0002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Pregnancy Related

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Sunnyside

ACTIVE COMPARATOR

An online intervention to better manage mood during and after pregnancy.

Behavioral: Sunnyside

SunnysideFlex

EXPERIMENTAL

An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy.

Behavioral: SunnysideFlex

Treatment as Usual

NO INTERVENTION

A control condition consisting of standard prenatal medical care, without provision of the SunnysideFlex or Sunnyside intervention

Interventions

Sunnyside BEHAVIORAL

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.

Sunnyside

SunnysideFlex BEHAVIORAL

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

SunnysideFlex

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Department of Psychology

Chicago, Illinois, 60607, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jennifer Duffecy, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: October 21, 2022
• Primary Completion: April 19, 2024
• Study Completion: October 2, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)