Swiss TrAumatic biRth Trial

Not Applicable

Completed

• Conditions: Acute Stress Disorder; Posttraumatic Stress Disorder
• Interventions: Behavioral: Attention placebo control; Behavioral: Brief computerized intervention

• Registration Number: NCT03576586
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-03
• Study Start: 2018-08-02
• Primary Completion: 2021-12-15
• Study Completion: 2022-02-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Attention placebo control	Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department
Intervention	Brief computerized intervention	Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department

Primary Outcome Measures

Name	Time	Method
presence and severity of PTSD symptoms: self-report (mother)	6 weeks postpartum	PTSD Checklist (PCL-5): subscale and total scores
presence and severity of PTSD symptoms: clinician-rated (mother)	6 weeks postpartum	Clinician-administered PTSD scale (CAPS): subscale and total scores

Secondary Outcome Measures

Name	Time	Method
presence and severity of ASD symptoms (mother)	< 6 hours after ECS, ≤ 1 week postpartum	Acute Stress Disorder Scale (ASDS): subscale and total scores
presence and severity of PTSD symptoms: self-report (mother)	6 months postpartum	PTSD Checklist (PCL-5): subscale and total scores
salivary cortisol: daily profile (mother and infant)	≤ 1 week and 6 months postpartum	daily profile
presence and severity of depression symptoms (mother)	< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum	Edinburgh Postnatal Depression Scale (EPDS): total score
presence and severity of anxiety symptoms (mother)	< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum	anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
infant behavior (mother)	6 months postpartum	Infant Behavior Questionnaire-very short form: total and subscale scores
presence and severity of PTSD symptoms: clinician-rated (mother)	6 months postpartum	Clinician-administered PTSD scale (CAPS): subscale and total scores
sleep time and duration (mother)	≤ 1 week postpartum	sleep diary
frequency of intrusive traumatic memories (mother)	≤ 1 week postpartum	traumatic intrusions diary
sleep quantity and quality (mother)	≤ 1 week, 6 weeks, 6 months postpartum	Pittsburgh Sleep Quality Index (PSQI): total score
salivary cortisol: stress reactivity (mother and infant)	≤ 1 week and 6 months postpartum	stress reactivity
heart rate variability: stress reactivity (mother and infant)	≤ 1 week and 6 months postpartum	stress reactivity
mother-infant-bonding (mother)	≤ 1 week, 6 weeks, 6 months postpartum	Mother-to-Infant-Bonding Scale (MIBS): total score
sleep and physical activity (mother)	≤ 1 week and 6 months postpartum	Overnight accelerometer assessments
heart rate variability: resting state (mother and infant)	≤ 1 week and 6 months postpartum	resting state
maternal emotional availability	6 months postpartum	Emotional Availability Scale: clinician-rated
infant development	6 months postpartum	Bayley Scales of Infant Development (Bayley-III): clinician-rated

Trial Locations

Locations (1)

Prof. Antje Horsch; 🇨🇭 Lausanne, Switzerland