NCT03576586

Swiss TrAumatic biRth Trial

Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section (ECS). Women who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention plus usual care or an attention placebo control group plus usual care within the first 6 hours following the ECS. Women and their infants will be followed up at ≤ 1 week postpartum, 6 weeks postpartum, and 6 months postpartum. It is predicted that women given the brief computerized intervention will develop fewer intrusive memories and less posttraumatic stress symptoms than those who are not. This will inform the development of a simple computerized early intervention to prevent distressing psychological symptoms after a traumatic event, such as an ECS.

Conditions

• Posttraumatic Stress Disorder
• Acute Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Brief computerized intervention	Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
BEHAVIORAL	Attention placebo control	Brief cognitive task plus usual care in the maternity department

Timeline

• Start date: 2018-08-02
• Primary completion: 2021-12-15
• Completion: 2022-02-08
• First posted: 2018-07-03
• Last updated: 2022-08-17

Locations

1 site across 1 country: Switzerland