Swiss TrAumatic biRth Trial (START)

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

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 Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Acute Stress Disorder
• Intervention / Treatment: Behavioral: Brief computerized intervention; Behavioral: Attention placebo control

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1010
    • Prof. Antje Horsch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department	Behavioral: Brief computerized intervention; Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
Placebo Comparator: Control; Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department	Behavioral: Attention placebo control; Brief cognitive task plus usual care in the maternity department

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
morningness-eveningness (mother)	Morningness-Eveningness Questionnaire (MEQ): total score	≤ 1 week postpartum
social support (mother, partner)	Modified Medical Outcomes Study Social Support Survey (MOS-8): total score	≤ 1 week, 6 weeks, 6 months postpartum
couple relationship adjustment (mother, partner)	Revised Dyadic Adjustment Scale (RDAS): subscale and total scores	≤ 1 week, 6 weeks, 6 months postpartum
parenting stress (mother, partner)	Parenting Stress Index - Short Form (PSI-SF): subscale and total scores	6 months postpartum
post-delivery perceived stress (mother)	Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores	≤ 1 week postpartum
postnatal perceived stress (mother)	Postnatal Perceived Stress Inventory (PPSI): subscale and total scores	6 months postpartum
self-reported life events (mother, partner)	Life Events Questionnaire	≤ 1 week and 6 months postpartum
breastfeeding	breastfeeding diary and questions	≤ 1 week, 6 weeks, 6 months postpartum
Dubowitz neurologic examination (infant)	structured clinical examination	≤ 1 week postpartum
frequency of intrusive traumatic memories (partner)	traumatic intrusions diary	≤ 1 week postpartum
presence and severity of PTSD symptoms: clinician-rated (partner)	Clinician-administered PTSD scale (CAPS): subscale and total scores	6 weeks, 6 months postpartum
presence and severity of PTSD symptoms: self-report (partner)	PTSD Checklist (PCL-5): subscale and total scores	6 weeks, 6 months postpartum
presence and severity of PTSD symptoms (partner)	Acute Stress Disorder Scale (ASDS): subscale and total scores	≤ 1 week postpartum
presence and severity of depression symptoms (partner)	Edinburgh Postnatal Depression Scale (EPDS): total scores	≤ 1 week, 6 weeks, 6 months postpartum
father-infant-bonding (partner)	Mother-to-Infant-Bonding Scale (MIBS): total score	≤ 1 week, 6 weeks, 6 months postpartum
participant feedback questionnaire (mother)	self-report questionnaire	< 6 hours after ECS
treatment credibility/expectancy questionnaire (mother)	self-report questionnaire	< 6 hours after ECS
presence and severity of anxiety symptoms (partner)	anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score	≤ 1 week, 6 weeks, 6 months postpartum
sleep quantity and quality (partner)	Pittsburgh Sleep Quality Index (PSQI): total score	≤ 1 week, 6 weeks, 6 months postpartum

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: University of Zurich; University Hospital, Geneva; University of Lausanne; University of Fribourg
• Investigators: Principal Investigator: Antje Horsch, D.Clin.Psych., University of Lausanne and Lausanne University Hospital

Publications and helpful links

General Publications

• Horsch A, Vial Y, Favrod C, Harari MM, Blackwell SE, Watson P, Iyadurai L, Bonsall MB, Holmes EA. Reducing intrusive traumatic memories after emergency caesarean section: A proof-of-principle randomized controlled study. Behav Res Ther. 2017 Jul;94:36-47. doi: 10.1016/j.brat.2017.03.018. Epub 2017 Apr 6.
• Sandoz V, Deforges C, Stuijfzand S, Epiney M, Vial Y, Sekarski N, Messerli-Burgy N, Ehlert U, Bickle-Graz M, Morisod Harari M, Porcheret K, Schechter DS, Ayers S, Holmes EA, Horsch A; START Research Consortium. Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START). BMJ Open. 2019 Dec 30;9(12):e032469. doi: 10.1136/bmjopen-2019-032469.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute
• Other Study ID Numbers: 2017-02142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No