Swiss TrAumatic biRth Trial (START)
Primary Purpose
Posttraumatic Stress Disorder, Acute Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Brief computerized intervention
Attention placebo control
Sponsored by
About this trial
This is an interventional prevention trial for Posttraumatic Stress Disorder
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
Sites / Locations
- Prof. Antje Horsch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department
Outcomes
Primary Outcome Measures
presence and severity of PTSD symptoms: clinician-rated (mother)
Clinician-administered PTSD scale (CAPS): subscale and total scores
presence and severity of PTSD symptoms: self-report (mother)
PTSD Checklist (PCL-5): subscale and total scores
Secondary Outcome Measures
frequency of intrusive traumatic memories (mother)
traumatic intrusions diary
presence and severity of ASD symptoms (mother)
Acute Stress Disorder Scale (ASDS): subscale and total scores
presence and severity of PTSD symptoms: self-report (mother)
PTSD Checklist (PCL-5): subscale and total scores
presence and severity of PTSD symptoms: clinician-rated (mother)
Clinician-administered PTSD scale (CAPS): subscale and total scores
presence and severity of anxiety symptoms (mother)
anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
sleep time and duration (mother)
sleep diary
sleep quantity and quality (mother)
Pittsburgh Sleep Quality Index (PSQI): total score
presence and severity of depression symptoms (mother)
Edinburgh Postnatal Depression Scale (EPDS): total score
sleep and physical activity (mother)
Overnight accelerometer assessments
salivary cortisol: daily profile (mother and infant)
daily profile
salivary cortisol: stress reactivity (mother and infant)
stress reactivity
heart rate variability: resting state (mother and infant)
resting state
heart rate variability: stress reactivity (mother and infant)
stress reactivity
infant behavior (mother)
Infant Behavior Questionnaire-very short form: total and subscale scores
infant development
Bayley Scales of Infant Development (Bayley-III): clinician-rated
mother-infant-bonding (mother)
Mother-to-Infant-Bonding Scale (MIBS): total score
maternal emotional availability
Emotional Availability Scale: clinician-rated
Full Information
NCT ID
NCT03576586
First Posted
June 4, 2018
Last Updated
August 16, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Lausanne, University Hospital, Geneva, University of Fribourg, University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT03576586
Brief Title
Swiss TrAumatic biRth Trial
Acronym
START
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
February 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Lausanne, University Hospital, Geneva, University of Fribourg, University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Acute Stress Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department
Intervention Type
Behavioral
Intervention Name(s)
Brief computerized intervention
Intervention Description
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
Intervention Type
Behavioral
Intervention Name(s)
Attention placebo control
Intervention Description
Brief cognitive task plus usual care in the maternity department
Primary Outcome Measure Information:
Title
presence and severity of PTSD symptoms: clinician-rated (mother)
Description
Clinician-administered PTSD scale (CAPS): subscale and total scores
Time Frame
6 weeks postpartum
Title
presence and severity of PTSD symptoms: self-report (mother)
Description
PTSD Checklist (PCL-5): subscale and total scores
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
frequency of intrusive traumatic memories (mother)
Description
traumatic intrusions diary
Time Frame
≤ 1 week postpartum
Title
presence and severity of ASD symptoms (mother)
Description
Acute Stress Disorder Scale (ASDS): subscale and total scores
Time Frame
< 6 hours after ECS, ≤ 1 week postpartum
Title
presence and severity of PTSD symptoms: self-report (mother)
Description
PTSD Checklist (PCL-5): subscale and total scores
Time Frame
6 months postpartum
Title
presence and severity of PTSD symptoms: clinician-rated (mother)
Description
Clinician-administered PTSD scale (CAPS): subscale and total scores
Time Frame
6 months postpartum
Title
presence and severity of anxiety symptoms (mother)
Description
anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
Time Frame
< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
Title
sleep time and duration (mother)
Description
sleep diary
Time Frame
≤ 1 week postpartum
Title
sleep quantity and quality (mother)
Description
Pittsburgh Sleep Quality Index (PSQI): total score
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
presence and severity of depression symptoms (mother)
Description
Edinburgh Postnatal Depression Scale (EPDS): total score
Time Frame
< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
Title
sleep and physical activity (mother)
Description
Overnight accelerometer assessments
Time Frame
≤ 1 week and 6 months postpartum
Title
salivary cortisol: daily profile (mother and infant)
Description
daily profile
Time Frame
≤ 1 week and 6 months postpartum
Title
salivary cortisol: stress reactivity (mother and infant)
Description
stress reactivity
Time Frame
≤ 1 week and 6 months postpartum
Title
heart rate variability: resting state (mother and infant)
Description
resting state
Time Frame
≤ 1 week and 6 months postpartum
Title
heart rate variability: stress reactivity (mother and infant)
Description
stress reactivity
Time Frame
≤ 1 week and 6 months postpartum
Title
infant behavior (mother)
Description
Infant Behavior Questionnaire-very short form: total and subscale scores
Time Frame
6 months postpartum
Title
infant development
Description
Bayley Scales of Infant Development (Bayley-III): clinician-rated
Time Frame
6 months postpartum
Title
mother-infant-bonding (mother)
Description
Mother-to-Infant-Bonding Scale (MIBS): total score
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
maternal emotional availability
Description
Emotional Availability Scale: clinician-rated
Time Frame
6 months postpartum
Other Pre-specified Outcome Measures:
Title
morningness-eveningness (mother)
Description
Morningness-Eveningness Questionnaire (MEQ): total score
Time Frame
≤ 1 week postpartum
Title
social support (mother, partner)
Description
Modified Medical Outcomes Study Social Support Survey (MOS-8): total score
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
couple relationship adjustment (mother, partner)
Description
Revised Dyadic Adjustment Scale (RDAS): subscale and total scores
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
parenting stress (mother, partner)
Description
Parenting Stress Index - Short Form (PSI-SF): subscale and total scores
Time Frame
6 months postpartum
Title
post-delivery perceived stress (mother)
Description
Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores
Time Frame
≤ 1 week postpartum
Title
postnatal perceived stress (mother)
Description
Postnatal Perceived Stress Inventory (PPSI): subscale and total scores
Time Frame
6 months postpartum
Title
self-reported life events (mother, partner)
Description
Life Events Questionnaire
Time Frame
≤ 1 week and 6 months postpartum
Title
breastfeeding
Description
breastfeeding diary and questions
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
Dubowitz neurologic examination (infant)
Description
structured clinical examination
Time Frame
≤ 1 week postpartum
Title
frequency of intrusive traumatic memories (partner)
Description
traumatic intrusions diary
Time Frame
≤ 1 week postpartum
Title
presence and severity of PTSD symptoms: clinician-rated (partner)
Description
Clinician-administered PTSD scale (CAPS): subscale and total scores
Time Frame
6 weeks, 6 months postpartum
Title
presence and severity of PTSD symptoms: self-report (partner)
Description
PTSD Checklist (PCL-5): subscale and total scores
Time Frame
6 weeks, 6 months postpartum
Title
presence and severity of PTSD symptoms (partner)
Description
Acute Stress Disorder Scale (ASDS): subscale and total scores
Time Frame
≤ 1 week postpartum
Title
presence and severity of depression symptoms (partner)
Description
Edinburgh Postnatal Depression Scale (EPDS): total scores
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
father-infant-bonding (partner)
Description
Mother-to-Infant-Bonding Scale (MIBS): total score
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
participant feedback questionnaire (mother)
Description
self-report questionnaire
Time Frame
< 6 hours after ECS
Title
treatment credibility/expectancy questionnaire (mother)
Description
self-report questionnaire
Time Frame
< 6 hours after ECS
Title
presence and severity of anxiety symptoms (partner)
Description
anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
Title
sleep quantity and quality (partner)
Description
Pittsburgh Sleep Quality Index (PSQI): total score
Time Frame
≤ 1 week, 6 weeks, 6 months postpartum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antje Horsch, D.Clin.Psych.
Organizational Affiliation
University of Lausanne and Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Antje Horsch
City
Lausanne
ZIP/Postal Code
1010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28453969
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.
Results Reference
background
PubMed Identifier
31892657
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.
Results Reference
derived
Learn more about this trial
Swiss TrAumatic biRth Trial
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