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Swiss TrAumatic biRth Trial (START)

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ClinicalTrials.gov Identifier: NCT03576586
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : September 10, 2020
Sponsor:
Collaborators:
University of Lausanne
University Hospital, Geneva
University of Fribourg
University of Zurich
Information provided by (Responsible Party):
Antje Horsch, Centre Hospitalier Universitaire Vaudois

Study Description
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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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Acute Stress Disorder Behavioral: Brief computerized intervention Behavioral: Attention placebo control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : February 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
 Behavioral: Brief computerized intervention
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
Placebo Comparator: Control
Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department
 Behavioral: Attention placebo control
Brief cognitive task plus usual care in the maternity department


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576586


Contacts
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Contact: Antje Horsch, D.Clin.Psych. +41 79 556 07 50 antje.horsch@chuv.ch
Contact: Vania Sandoz, M.Sc. +41 79 556 75 36 vania.sandoz@chuv.ch

Locations
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Switzerland
Prof. Antje Horsch Recruiting
Lausanne, Switzerland, 1010
Contact: Antje Horsch, DClinPsych.    0795551335    antje.horsch@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University of Lausanne
University Hospital, Geneva
University of Fribourg
University of Zurich
Investigators
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Principal Investigator: Antje Horsch, D.Clin.Psych. University of Lausanne and Lausanne University Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Antje Horsch, Assistant Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03576586    
Other Study ID Numbers: 2017-02142
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
 Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders