Trials / Completed
CompletedNCT04992767
Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- University of Illinois at Chicago · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | 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 |
Timeline
- Start date
- 2022-10-21
- Primary completion
- 2024-04-19
- Completion
- 2024-10-02
- First posted
- 2021-08-05
- Last updated
- 2025-03-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04992767. Inclusion in this directory is not an endorsement.