Clinical trial NCT03576586: Swiss TrAumatic biRth Trial
Official title: Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Acute Stress Disorder
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: University Hospital, Geneva
name: University of Fribourg
name: University of Zurich
First posted: 2018-07-03
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: presence and severity of PTSD symptoms: clinician-rated (mother)
timeFrame: 6 weeks postpartum
measure: presence and severity of PTSD symptoms: self-report (mother)
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: frequency of intrusive traumatic memories (mother)
timeFrame: ≤ 1 week postpartum
measure: presence and severity of ASD symptoms (mother)
timeFrame: < 6 hours after ECS, ≤ 1 week postpartum
measure: presence and severity of PTSD symptoms: self-report (mother)
timeFrame: 6 months postpartum
measure: presence and severity of PTSD symptoms: clinician-rated (mother)
timeFrame: 6 months postpartum
measure: presence and severity of anxiety symptoms (mother)
timeFrame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
measure: sleep time and duration (mother)
timeFrame: ≤ 1 week postpartum
measure: sleep quantity and quality (mother)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: presence and severity of depression symptoms (mother)
timeFrame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
measure: sleep and physical activity (mother)
timeFrame: ≤ 1 week and 6 months postpartum
measure: salivary cortisol: daily profile (mother and infant)
timeFrame: ≤ 1 week and 6 months postpartum
measure: salivary cortisol: stress reactivity (mother and infant)
timeFrame: ≤ 1 week and 6 months postpartum
measure: heart rate variability: resting state (mother and infant)
timeFrame: ≤ 1 week and 6 months postpartum
measure: heart rate variability: stress reactivity (mother and infant)
timeFrame: ≤ 1 week and 6 months postpartum
measure: infant behavior (mother)
timeFrame: 6 months postpartum
measure: infant development
timeFrame: 6 months postpartum
measure: mother-infant-bonding (mother)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: maternal emotional availability
timeFrame: 6 months postpartum
Other outcomes:
measure: morningness-eveningness (mother)
timeFrame: ≤ 1 week postpartum
measure: social support (mother, partner)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: couple relationship adjustment (mother, partner)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: parenting stress (mother, partner)
timeFrame: 6 months postpartum
measure: post-delivery perceived stress (mother)
timeFrame: ≤ 1 week postpartum
measure: postnatal perceived stress (mother)
timeFrame: 6 months postpartum
measure: self-reported life events (mother, partner)
timeFrame: ≤ 1 week and 6 months postpartum
measure: breastfeeding
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: Dubowitz neurologic examination (infant)
timeFrame: ≤ 1 week postpartum
measure: frequency of intrusive traumatic memories (partner)
timeFrame: ≤ 1 week postpartum
measure: presence and severity of PTSD symptoms: clinician-rated (partner)
timeFrame: 6 weeks, 6 months postpartum
measure: presence and severity of PTSD symptoms: self-report (partner)
timeFrame: 6 weeks, 6 months postpartum
measure: presence and severity of PTSD symptoms (partner)
timeFrame: ≤ 1 week postpartum
measure: presence and severity of depression symptoms (partner)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: father-infant-bonding (partner)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: participant feedback questionnaire (mother)
timeFrame: < 6 hours after ECS
measure: treatment credibility/expectancy questionnaire (mother)
timeFrame: < 6 hours after ECS
measure: presence and severity of anxiety symptoms (partner)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
measure: sleep quantity and quality (partner)
timeFrame: ≤ 1 week, 6 weeks, 6 months postpartum
Locations:
city: Lausanne
country: Switzerland
facility: Prof. Antje Horsch
Study officials:
affiliation: University of Lausanne and Lausanne University Hospital
name: Antje Horsch, D.Clin.Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.