Swiss TrAumatic biRth Trial

Posttraumatic Stress Disorder Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576586
• Other study ID #: 2017-02142
• Status: Completed
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: February 8, 2022

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: February 8, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stress Disorder
• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

Behavioral:
• Brief computerized intervention
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
• Attention placebo control
Brief cognitive task plus usual care in the maternity department

Locations

Country	Name	City	State
Switzerland	Prof. Antje Horsch	Lausanne

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	University Hospital, Geneva, University of Fribourg, University of Lausanne, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	morningness-eveningness (mother)	Morningness-Eveningness Questionnaire (MEQ): total score	= 1 week postpartum
Other	social support (mother, partner)	Modified Medical Outcomes Study Social Support Survey (MOS-8): total score	= 1 week, 6 weeks, 6 months postpartum
Other	couple relationship adjustment (mother, partner)	Revised Dyadic Adjustment Scale (RDAS): subscale and total scores	= 1 week, 6 weeks, 6 months postpartum
Other	parenting stress (mother, partner)	Parenting Stress Index - Short Form (PSI-SF): subscale and total scores	6 months postpartum
Other	post-delivery perceived stress (mother)	Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores	= 1 week postpartum
Other	postnatal perceived stress (mother)	Postnatal Perceived Stress Inventory (PPSI): subscale and total scores	6 months postpartum
Other	self-reported life events (mother, partner)	Life Events Questionnaire	= 1 week and 6 months postpartum
Other	breastfeeding	breastfeeding diary and questions	= 1 week, 6 weeks, 6 months postpartum
Other	Dubowitz neurologic examination (infant)	structured clinical examination	= 1 week postpartum
Other	frequency of intrusive traumatic memories (partner)	traumatic intrusions diary	= 1 week postpartum
Other	presence and severity of PTSD symptoms: clinician-rated (partner)	Clinician-administered PTSD scale (CAPS): subscale and total scores	6 weeks, 6 months postpartum
Other	presence and severity of PTSD symptoms: self-report (partner)	PTSD Checklist (PCL-5): subscale and total scores	6 weeks, 6 months postpartum
Other	presence and severity of PTSD symptoms (partner)	Acute Stress Disorder Scale (ASDS): subscale and total scores	= 1 week postpartum
Other	presence and severity of depression symptoms (partner)	Edinburgh Postnatal Depression Scale (EPDS): total scores	= 1 week, 6 weeks, 6 months postpartum
Other	father-infant-bonding (partner)	Mother-to-Infant-Bonding Scale (MIBS): total score	= 1 week, 6 weeks, 6 months postpartum
Other	participant feedback questionnaire (mother)	self-report questionnaire	< 6 hours after ECS
Other	treatment credibility/expectancy questionnaire (mother)	self-report questionnaire	< 6 hours after ECS
Other	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
Other	sleep quantity and quality (partner)	Pittsburgh Sleep Quality Index (PSQI): total score	= 1 week, 6 weeks, 6 months postpartum
Primary	presence and severity of PTSD symptoms: clinician-rated (mother)	Clinician-administered PTSD scale (CAPS): subscale and total scores	6 weeks postpartum
Primary	presence and severity of PTSD symptoms: self-report (mother)	PTSD Checklist (PCL-5): subscale and total scores	6 weeks postpartum
Secondary	frequency of intrusive traumatic memories (mother)	traumatic intrusions diary	= 1 week postpartum
Secondary	presence and severity of ASD symptoms (mother)	Acute Stress Disorder Scale (ASDS): subscale and total scores	< 6 hours after ECS, = 1 week postpartum
Secondary	presence and severity of PTSD symptoms: self-report (mother)	PTSD Checklist (PCL-5): subscale and total scores	6 months postpartum
Secondary	presence and severity of PTSD symptoms: clinician-rated (mother)	Clinician-administered PTSD scale (CAPS): subscale and total scores	6 months postpartum
Secondary	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
Secondary	sleep time and duration (mother)	sleep diary	= 1 week postpartum
Secondary	sleep quantity and quality (mother)	Pittsburgh Sleep Quality Index (PSQI): total score	= 1 week, 6 weeks, 6 months postpartum
Secondary	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
Secondary	sleep and physical activity (mother)	Overnight accelerometer assessments	= 1 week and 6 months postpartum
Secondary	salivary cortisol: daily profile (mother and infant)	daily profile	= 1 week and 6 months postpartum
Secondary	salivary cortisol: stress reactivity (mother and infant)	stress reactivity	= 1 week and 6 months postpartum
Secondary	heart rate variability: resting state (mother and infant)	resting state	= 1 week and 6 months postpartum
Secondary	heart rate variability: stress reactivity (mother and infant)	stress reactivity	= 1 week and 6 months postpartum
Secondary	infant behavior (mother)	Infant Behavior Questionnaire-very short form: total and subscale scores	6 months postpartum
Secondary	infant development	Bayley Scales of Infant Development (Bayley-III): clinician-rated	6 months postpartum
Secondary	mother-infant-bonding (mother)	Mother-to-Infant-Bonding Scale (MIBS): total score	= 1 week, 6 weeks, 6 months postpartum
Secondary	maternal emotional availability	Emotional Availability Scale: clinician-rated	6 months postpartum