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CompletedNCT03576586STARTUpdated Aug 17, 2022

Swiss TrAumatic biRth Trial

An interventional study of Brief computerized intervention and Attention placebo control in Posttraumatic Stress Disorder and Acute Stress Disorder, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Acute Stress Disorder
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 147 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
147 participants (actual)

Study arms

  • Experimental
    Intervention

    Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department

    Behavioral: Brief computerized intervention

  • Placebo comparator
    Control

    Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department

    Behavioral: Attention placebo control

Interventions

  • BehavioralBrief computerized intervention

    Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department

  • BehavioralAttention placebo control

    Brief cognitive task plus usual care in the maternity department

06

What researchers measure

Primary outcomes

  1. presence and severity of PTSD symptoms: clinician-rated (mother)

    Clinician-administered PTSD scale (CAPS): subscale and total scores

    Time frame: 6 weeks postpartum

  2. presence and severity of PTSD symptoms: self-report (mother)

    PTSD Checklist (PCL-5): subscale and total scores

    Time frame: 6 weeks postpartum

Secondary outcomes

  1. frequency of intrusive traumatic memories (mother)

    traumatic intrusions diary

    Time frame: ≤ 1 week postpartum

  2. presence and severity of ASD symptoms (mother)

    Acute Stress Disorder Scale (ASDS): subscale and total scores

    Time frame: < 6 hours after ECS, ≤ 1 week postpartum

  3. presence and severity of PTSD symptoms: self-report (mother)

    PTSD Checklist (PCL-5): subscale and total scores

    Time frame: 6 months postpartum

  4. presence and severity of PTSD symptoms: clinician-rated (mother)

    Clinician-administered PTSD scale (CAPS): subscale and total scores

    Time frame: 6 months postpartum

  5. presence and severity of anxiety symptoms (mother)

    anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score

    Time frame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum

  6. sleep time and duration (mother)

    sleep diary

    Time frame: ≤ 1 week postpartum

  7. sleep quantity and quality (mother)

    Pittsburgh Sleep Quality Index (PSQI): total score

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  8. presence and severity of depression symptoms (mother)

    Edinburgh Postnatal Depression Scale (EPDS): total score

    Time frame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum

  9. sleep and physical activity (mother)

    Overnight accelerometer assessments

    Time frame: ≤ 1 week and 6 months postpartum

  10. salivary cortisol: daily profile (mother and infant)

    daily profile

    Time frame: ≤ 1 week and 6 months postpartum

  11. salivary cortisol: stress reactivity (mother and infant)

    stress reactivity

    Time frame: ≤ 1 week and 6 months postpartum

  12. heart rate variability: resting state (mother and infant)

    resting state

    Time frame: ≤ 1 week and 6 months postpartum

  13. heart rate variability: stress reactivity (mother and infant)

    stress reactivity

    Time frame: ≤ 1 week and 6 months postpartum

  14. infant behavior (mother)

    Infant Behavior Questionnaire-very short form: total and subscale scores

    Time frame: 6 months postpartum

  15. infant development

    Bayley Scales of Infant Development (Bayley-III): clinician-rated

    Time frame: 6 months postpartum

  16. mother-infant-bonding (mother)

    Mother-to-Infant-Bonding Scale (MIBS): total score

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  17. maternal emotional availability

    Emotional Availability Scale: clinician-rated

    Time frame: 6 months postpartum

Other outcomes

  1. morningness-eveningness (mother)

    Morningness-Eveningness Questionnaire (MEQ): total score

    Time frame: ≤ 1 week postpartum

  2. social support (mother, partner)

    Modified Medical Outcomes Study Social Support Survey (MOS-8): total score

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  3. couple relationship adjustment (mother, partner)

    Revised Dyadic Adjustment Scale (RDAS): subscale and total scores

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  4. parenting stress (mother, partner)

    Parenting Stress Index - Short Form (PSI-SF): subscale and total scores

    Time frame: 6 months postpartum

  5. post-delivery perceived stress (mother)

    Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores

    Time frame: ≤ 1 week postpartum

  6. postnatal perceived stress (mother)

    Postnatal Perceived Stress Inventory (PPSI): subscale and total scores

    Time frame: 6 months postpartum

  7. self-reported life events (mother, partner)

    Life Events Questionnaire

    Time frame: ≤ 1 week and 6 months postpartum

  8. breastfeeding

    breastfeeding diary and questions

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  9. Dubowitz neurologic examination (infant)

    structured clinical examination

    Time frame: ≤ 1 week postpartum

  10. frequency of intrusive traumatic memories (partner)

    traumatic intrusions diary

    Time frame: ≤ 1 week postpartum

  11. presence and severity of PTSD symptoms: clinician-rated (partner)

    Clinician-administered PTSD scale (CAPS): subscale and total scores

    Time frame: 6 weeks, 6 months postpartum

  12. presence and severity of PTSD symptoms: self-report (partner)

    PTSD Checklist (PCL-5): subscale and total scores

    Time frame: 6 weeks, 6 months postpartum

  13. presence and severity of PTSD symptoms (partner)

    Acute Stress Disorder Scale (ASDS): subscale and total scores

    Time frame: ≤ 1 week postpartum

  14. presence and severity of depression symptoms (partner)

    Edinburgh Postnatal Depression Scale (EPDS): total scores

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  15. father-infant-bonding (partner)

    Mother-to-Infant-Bonding Scale (MIBS): total score

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  16. participant feedback questionnaire (mother)

    self-report questionnaire

    Time frame: < 6 hours after ECS

  17. treatment credibility/expectancy questionnaire (mother)

    self-report questionnaire

    Time frame: < 6 hours after ECS

  18. presence and severity of anxiety symptoms (partner)

    anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

  19. sleep quantity and quality (partner)

    Pittsburgh Sleep Quality Index (PSQI): total score

    Time frame: ≤ 1 week, 6 weeks, 6 months postpartum

07

Study locations

1 site
  • Prof. Antje Horsch
    Lausanne, 1010, Switzerland
08

References and documents

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. PubMed 28453969 ↗
  • 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. PubMed 31892657 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03576586
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Lausanne, University Hospital, Geneva, University of Fribourg, University of Zurich
Responsible party
Antje Horsch (Assistant Professor, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Jul 3, 2018
Start date
Aug 2, 2018
Primary completion
Dec 15, 2021
Completion
Feb 8, 2022
Last update
Aug 17, 2022

Study contacts

Antje Horsch, D.Clin.Psych.
principal investigator · University of Lausanne and Lausanne University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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