Swiss TrAumatic biRth Trial

Centre Hospitalier Universitaire Vaudois147 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

147

Conditions

Posttraumatic Stress Disorder Acute Stress Disorder

Interventions

Brief computerized interventionBEHAVIORAL

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

Attention placebo controlBEHAVIORAL

Brief cognitive task plus usual care in the maternity department

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prof. Antje Horsch

Lausanne, Switzerland

Outcomes

Primary Outcomes

presence and severity of PTSD symptoms: clinician-rated (mother)

Clinician-administered PTSD scale (CAPS): subscale and total scores

Time frame: 6 weeks postpartum

presence and severity of PTSD symptoms: self-report (mother)

PTSD Checklist (PCL-5): subscale and total scores

Time frame: 6 weeks postpartum

Secondary Outcomes

frequency of intrusive traumatic memories (mother)

traumatic intrusions diary

Time frame: ≤ 1 week postpartum

presence and severity of ASD symptoms (mother)

Acute Stress Disorder Scale (ASDS): subscale and total scores

Time frame: < 6 hours after ECS, ≤ 1 week postpartum

presence and severity of PTSD symptoms: self-report (mother)

PTSD Checklist (PCL-5): subscale and total scores

Time frame: 6 months postpartum

presence and severity of PTSD symptoms: clinician-rated (mother)

Clinician-administered PTSD scale (CAPS): subscale and total scores

Time frame: 6 months postpartum

presence and severity of anxiety symptoms (mother)

anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score

Time frame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum

sleep time and duration (mother)

sleep diary

Time frame: ≤ 1 week postpartum

sleep quantity and quality (mother)

Pittsburgh Sleep Quality Index (PSQI): total score

Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

presence and severity of depression symptoms (mother)

Edinburgh Postnatal Depression Scale (EPDS): total score

Time frame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum

sleep and physical activity (mother)

Overnight accelerometer assessments