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Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

Primary Purpose

Posttraumatic Stress Disorder, Pregnancy Related

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sunnyside
SunnysideFlex
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Illinois Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Sunnyside

SunnysideFlex

Treatment as Usual

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2021
Last Updated
October 30, 2022
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04992767
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Pregnancy Related

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sunnyside
Arm Type
Active Comparator
Arm Description
An online intervention to better manage mood during and after pregnancy.
Arm Title
SunnysideFlex
Arm Type
Experimental
Arm Description
An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
A control condition consisting of standard prenatal medical care, without provision of the SunnysideFlex or Sunnyside intervention
Intervention Type
Behavioral
Intervention Name(s)
Sunnyside
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SunnysideFlex
Intervention Description
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
Primary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Past 30 days
Title
Impact of Events Scale - Revised (IES-R)
Description
The IES-R assesses the past-week frequency of PTSD symptoms in reference to the participant's self-identified worst traumatic event
Time Frame
1 week
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Berenz, PhD
Phone
(312) 355-0808
Email
eberenz@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin C Berenz, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Department of Psychology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Berenz, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

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