Swiss TrAumatic biRth Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2022-02-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Posttraumatic Stress Disorder Acute Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Brief computerized intervention

Intervention Type BEHAVIORAL

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

Control

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

Group Type PLACEBO_COMPARATOR

Attention placebo control

Intervention Type BEHAVIORAL

Brief cognitive task plus usual care in the maternity department

Interventions

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Brief computerized intervention

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

Intervention Type BEHAVIORAL

Attention placebo control

Brief cognitive task plus usual care in the maternity department

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No