Swiss TrAumatic biRth Trial (START)

August 16, 2022 updated by: Antje Horsch, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1010
        • Prof. Antje Horsch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
presence and severity of PTSD symptoms: clinician-rated (mother)
Time Frame: 6 weeks postpartum
Clinician-administered PTSD scale (CAPS): subscale and total scores
6 weeks postpartum
presence and severity of PTSD symptoms: self-report (mother)
Time Frame: 6 weeks postpartum
PTSD Checklist (PCL-5): subscale and total scores
6 weeks postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
frequency of intrusive traumatic memories (mother)
Time Frame: ≤ 1 week postpartum
traumatic intrusions diary
≤ 1 week postpartum
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
< 6 hours after ECS, ≤ 1 week postpartum
presence and severity of PTSD symptoms: self-report (mother)
Time Frame: 6 months postpartum
PTSD Checklist (PCL-5): subscale and total scores
6 months postpartum
presence and severity of PTSD symptoms: clinician-rated (mother)
Time Frame: 6 months postpartum
Clinician-administered PTSD scale (CAPS): subscale and total scores
6 months postpartum
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 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
sleep time and duration (mother)
Time Frame: ≤ 1 week postpartum
sleep diary
≤ 1 week postpartum
sleep quantity and quality (mother)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Pittsburgh Sleep Quality Index (PSQI): total score
≤ 1 week, 6 weeks, 6 months postpartum
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
< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
sleep and physical activity (mother)
Time Frame: ≤ 1 week and 6 months postpartum
Overnight accelerometer assessments
≤ 1 week and 6 months postpartum
salivary cortisol: daily profile (mother and infant)
Time Frame: ≤ 1 week and 6 months postpartum
daily profile
≤ 1 week and 6 months postpartum
salivary cortisol: stress reactivity (mother and infant)
Time Frame: ≤ 1 week and 6 months postpartum
stress reactivity
≤ 1 week and 6 months postpartum
heart rate variability: resting state (mother and infant)
Time Frame: ≤ 1 week and 6 months postpartum
resting state
≤ 1 week and 6 months postpartum
heart rate variability: stress reactivity (mother and infant)
Time Frame: ≤ 1 week and 6 months postpartum
stress reactivity
≤ 1 week and 6 months postpartum
infant behavior (mother)
Time Frame: 6 months postpartum
Infant Behavior Questionnaire-very short form: total and subscale scores
6 months postpartum
infant development
Time Frame: 6 months postpartum
Bayley Scales of Infant Development (Bayley-III): clinician-rated
6 months postpartum
mother-infant-bonding (mother)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Mother-to-Infant-Bonding Scale (MIBS): total score
≤ 1 week, 6 weeks, 6 months postpartum
maternal emotional availability
Time Frame: 6 months postpartum
Emotional Availability Scale: clinician-rated
6 months postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
morningness-eveningness (mother)
Time Frame: ≤ 1 week postpartum
Morningness-Eveningness Questionnaire (MEQ): total score
≤ 1 week postpartum
social support (mother, partner)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Modified Medical Outcomes Study Social Support Survey (MOS-8): total score
≤ 1 week, 6 weeks, 6 months postpartum
couple relationship adjustment (mother, partner)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Revised Dyadic Adjustment Scale (RDAS): subscale and total scores
≤ 1 week, 6 weeks, 6 months postpartum
parenting stress (mother, partner)
Time Frame: 6 months postpartum
Parenting Stress Index - Short Form (PSI-SF): subscale and total scores
6 months postpartum
post-delivery perceived stress (mother)
Time Frame: ≤ 1 week postpartum
Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores
≤ 1 week postpartum
postnatal perceived stress (mother)
Time Frame: 6 months postpartum
Postnatal Perceived Stress Inventory (PPSI): subscale and total scores
6 months postpartum
self-reported life events (mother, partner)
Time Frame: ≤ 1 week and 6 months postpartum
Life Events Questionnaire
≤ 1 week and 6 months postpartum
breastfeeding
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
breastfeeding diary and questions
≤ 1 week, 6 weeks, 6 months postpartum
Dubowitz neurologic examination (infant)
Time Frame: ≤ 1 week postpartum
structured clinical examination
≤ 1 week postpartum
frequency of intrusive traumatic memories (partner)
Time Frame: ≤ 1 week postpartum
traumatic intrusions diary
≤ 1 week postpartum
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
6 weeks, 6 months postpartum
presence and severity of PTSD symptoms: self-report (partner)
Time Frame: 6 weeks, 6 months postpartum
PTSD Checklist (PCL-5): subscale and total scores
6 weeks, 6 months postpartum
presence and severity of PTSD symptoms (partner)
Time Frame: ≤ 1 week postpartum
Acute Stress Disorder Scale (ASDS): subscale and total scores
≤ 1 week postpartum
presence and severity of depression symptoms (partner)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS): total scores
≤ 1 week, 6 weeks, 6 months postpartum
father-infant-bonding (partner)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Mother-to-Infant-Bonding Scale (MIBS): total score
≤ 1 week, 6 weeks, 6 months postpartum
participant feedback questionnaire (mother)
Time Frame: < 6 hours after ECS
self-report questionnaire
< 6 hours after ECS
treatment credibility/expectancy questionnaire (mother)
Time Frame: < 6 hours after ECS
self-report questionnaire
< 6 hours after ECS
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
≤ 1 week, 6 weeks, 6 months postpartum
sleep quantity and quality (partner)
Time Frame: ≤ 1 week, 6 weeks, 6 months postpartum
Pittsburgh Sleep Quality Index (PSQI): total score
≤ 1 week, 6 weeks, 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Vaudois

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich
University Hospital, Geneva
University of Lausanne
University of Fribourg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antje Horsch, D.Clin.Psych., University of Lausanne and Lausanne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-02142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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