Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • High Risk Pregnancy
  • Pregnancy Complications
  • Stress Physiological
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Controlled TrialMasking: Double (Participant, Investigator)Masking Description: Participants will have identical journals regardless of the intervention or control group status, and providers will be blinded to the writing prompts that participants are given. Women who are randomized to 'no writing' will be provided a blank journal without any instruction. this will be considered a 'gift' for study participationPrimary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

Description

During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to optimize mental health, positively impacting outcomes. Cumulative psychosocial stress is a risk factor for several adverse obstetric outcomes including preterm birth (PTB), pree...

During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to optimize mental health, positively impacting outcomes. Cumulative psychosocial stress is a risk factor for several adverse obstetric outcomes including preterm birth (PTB), preeclampsia, fetal growth restriction, and postpartum depression. The overarching hypothesis of this study is that pregnant women with high levels of stress can be identified through easily-implemented screening tools; importantly, the investigators propose that these women can be engaged in care via a cost-effective therapeutic writing intervention combined with the availability of expert pastoral and perinatal psychiatry resources. Women will be enrolled early in pregnancy and followed prospectively. Some women (if randomized to a writing group) will complete a standardized writing prompt at several time points during gestation. The investigators will follow their outcomes prospectively.

Tracking Information

NCT #
NCT03904979
Collaborators
Not Provided
Investigators
Principal Investigator: Tracy A Manuck, MD University of North Carolina, Chapel Hill