Clinical trial NCT04992767: Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
Official title: Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Pregnancy Related
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Past 30 days
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: 1 week
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Department of Psychology
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jennifer Duffecy, PhD
role: PRINCIPAL_INVESTIGATOR
References: