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Completed

NCT Number: NCT03576586

Swiss TrAumatic biRth Trial

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.

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Key information

Conditions

Posttraumatic Stress Disorder Acute Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress Disorders, Traumatic, Acute Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Antje Horsch

Lausanne, 1010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief computerized intervention

Behavioral

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

Attention placebo control

Behavioral

Brief cognitive task plus usual care in the maternity department

Primary outcomes

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

    Time frame: 6 weeks postpartum

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

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

    Time frame: 6 weeks postpartum

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

Secondary outcomes

  1. frequency of intrusive traumatic memories (mother)

    Time frame: ≤ 1 week postpartum

    traumatic intrusions diary

  2. presence and severity of ASD symptoms (mother)

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

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

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

    Time frame: 6 months postpartum

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

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

    Time frame: 6 months postpartum

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

  5. presence and severity of anxiety symptoms (mother)

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

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

  6. sleep time and duration (mother)

    Time frame: ≤ 1 week postpartum

    sleep diary

  7. sleep quantity and quality (mother)

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

    Pittsburgh Sleep Quality Index (PSQI): total score

  8. presence and severity of depression symptoms (mother)

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

    Edinburgh Postnatal Depression Scale (EPDS): total score

  9. sleep and physical activity (mother)

    Time frame: ≤ 1 week and 6 months postpartum

    Overnight accelerometer assessments

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

    Time frame: ≤ 1 week and 6 months postpartum

    daily profile

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

    Time frame: ≤ 1 week and 6 months postpartum

    stress reactivity

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

    Time frame: ≤ 1 week and 6 months postpartum

    resting state

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

    Time frame: ≤ 1 week and 6 months postpartum

    stress reactivity

  14. infant behavior (mother)

    Time frame: 6 months postpartum

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

  15. infant development

    Time frame: 6 months postpartum

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

  16. mother-infant-bonding (mother)

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

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

  17. maternal emotional availability

    Time frame: 6 months postpartum

    Emotional Availability Scale: clinician-rated

Other outcomes

  1. morningness-eveningness (mother)

    Time frame: ≤ 1 week postpartum

    Morningness-Eveningness Questionnaire (MEQ): total score

  2. social support (mother, partner)

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

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

  3. couple relationship adjustment (mother, partner)

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

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

  4. parenting stress (mother, partner)

    Time frame: 6 months postpartum

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

  5. post-delivery perceived stress (mother)

    Time frame: ≤ 1 week postpartum

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

  6. postnatal perceived stress (mother)

    Time frame: 6 months postpartum

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

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

    Time frame: ≤ 1 week and 6 months postpartum

    Life Events Questionnaire

  8. breastfeeding

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

    breastfeeding diary and questions

  9. Dubowitz neurologic examination (infant)

    Time frame: ≤ 1 week postpartum

    structured clinical examination

  10. frequency of intrusive traumatic memories (partner)

    Time frame: ≤ 1 week postpartum

    traumatic intrusions diary

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

    Time frame: 6 weeks, 6 months postpartum

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

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

    Time frame: 6 weeks, 6 months postpartum

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

  13. presence and severity of PTSD symptoms (partner)

    Time frame: ≤ 1 week postpartum

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

  14. presence and severity of depression symptoms (partner)

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

    Edinburgh Postnatal Depression Scale (EPDS): total scores

  15. father-infant-bonding (partner)

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

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

  16. participant feedback questionnaire (mother)

    Time frame: < 6 hours after ECS

    self-report questionnaire

  17. treatment credibility/expectancy questionnaire (mother)

    Time frame: < 6 hours after ECS

    self-report questionnaire

  18. presence and severity of anxiety symptoms (partner)

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

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

  19. sleep quantity and quality (partner)

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

    Pittsburgh Sleep Quality Index (PSQI): total score

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • University Hospital, Geneva
  • University of Fribourg
  • University of Lausanne
  • University of Zurich

Registry information

Official study title

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

Acronym: START

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 3, 2018
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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