Swiss TrAumatic biRth Trial (START)

Vaud University Hospital Center

Status: Completed

Conditions: Posttraumatic Stress Disorder; Acute Stress Disorder

Treatments: Behavioral: Brief computerized intervention; Behavioral: Attention placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT03576586

2017-02142

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Women:

• had an ECS at ≥ 34 weeks gestation
• gave birth to a live baby
• answered with a score of ≥ 2 separately for at least two out of four screening questions regarding perceived threat
• gave written consent

Partners:

• if the woman agrees to participate
• was present at the childbirth
• gave written consent

Exclusion criteria

Women:

• don't speak French sufficiently well to participate in assessments
• have an established intellectual disability or psychotic illness
• severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
• infant requires intensive care
• alcohol abuse and/or illegal drug use during pregnancy

Partner:

• don't speak French sufficiently well to participate in assessments

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department

Treatment:

Behavioral: Brief computerized intervention

Control

Placebo Comparator group

Description:

Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department

Treatment:

Behavioral: Attention placebo control