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Sunnyside and SunnysideFlex for Pregnancy and Post-Traumatic Stress Disorder
N/A
Waitlist Available
Led By Erin C Berenz, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up past 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests SunnysideFlex, an online program for pregnant women with PTSD symptoms. It aims to help them manage stress and improve mood through web-based lessons.
Eligible Conditions
- Post Traumatic Stress Disorder
- Pregnancy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ past 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Impact of Events Scale - Revised (IES-R)
PTSD Checklist for DSM-5 (PCL-5)
Patient Health Questionnaire-9 (PHQ-9)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: SunnysideFlexExperimental Treatment1 Intervention
An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy.
Group II: SunnysideActive Control1 Intervention
An online intervention to better manage mood during and after pregnancy.
Group III: Treatment as UsualActive Control1 Intervention
A control condition consisting of standard prenatal medical care, without provision of the SunnysideFlex or Sunnyside intervention
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,963 Total Patients Enrolled
Erin C Berenz, PhDPrincipal InvestigatorUniversity of Illinois at Chicago
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a fast and reliable internet connection.You have a mental health condition, such as bipolar disorder or substance use disorder, that may make it unsafe for you to participate in this trial.You are currently in a dangerous or abusive relationship.You have a score of 33 or higher on the PTSD Checklist for DSM-5 (PCL-5).You can understand and speak English.You have difficulty seeing, hearing, speaking or moving that may make it hard for you to participate in the study.You are a woman.You must be at least 18 years old.You are pregnant and between 4-7 months along.You are currently receiving care from a healthcare provider during pregnancy.You have experienced a traumatic event that involved a threat to your life, serious injury or sexual violence. This includes events such as physical or sexual assault, child abuse, witnessing family violence or similar interpersonal incidents. This is based on the guidelines in the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5).
Research Study Groups:
This trial has the following groups:- Group 1: Sunnyside
- Group 2: SunnysideFlex
- Group 3: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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