Posttraumatic Stress DisorderSTARTNCT03576586
Swiss TrAumatic biRth Trial
A study testing Brief computerized intervention in people with Posttraumatic Stress Disorder and Acute Stress Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Acute Stress Disorder
- What is being tested?
- Brief computerized intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2018to 8 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- if the woman agrees to participate
- was present at the childbirth
- gave written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Brief computerized intervention, Attention placebo control
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief computerized interventionBehavioural
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
Attention placebo controlBehavioural
Brief cognitive task plus usual care in the maternity department
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department Receives: Behavioral: Brief computerized intervention |
| Control | Placebo comparator | Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department Receives: Behavioral: Attention placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence and severity of PTSD symptoms: clinician-rated (mother)
Clinician-administered PTSD scale (CAPS): subscale and total scores
Measured: 6 weeks postpartum
presence and severity of PTSD symptoms: self-report (mother)
PTSD Checklist (PCL-5): subscale and total scores
Measured: 6 weeks postpartum
Secondary outcomes (17)
frequency of intrusive traumatic memories (mother)
traumatic intrusions diary
Measured: ≤ 1 week postpartum
presence and severity of ASD symptoms (mother)
Acute Stress Disorder Scale (ASDS): subscale and total scores
Measured: < 6 hours after ECS, ≤ 1 week postpartum
presence and severity of PTSD symptoms: self-report (mother)
PTSD Checklist (PCL-5): subscale and total scores
Measured: 6 months postpartum
presence and severity of PTSD symptoms: clinician-rated (mother)
Clinician-administered PTSD scale (CAPS): subscale and total scores
Measured: 6 months postpartum
presence and severity of anxiety symptoms (mother)
anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
Measured: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
sleep time and duration (mother)
sleep diary
Measured: ≤ 1 week postpartum
sleep quantity and quality (mother)
Pittsburgh Sleep Quality Index (PSQI): total score
Measured: ≤ 1 week, 6 weeks, 6 months postpartum
presence and severity of depression symptoms (mother)
Edinburgh Postnatal Depression Scale (EPDS): total score
Measured: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
sleep and physical activity (mother)
Overnight accelerometer assessments
Measured: ≤ 1 week and 6 months postpartum
salivary cortisol: daily profile (mother and infant)
daily profile
Measured: ≤ 1 week and 6 months postpartum
salivary cortisol: stress reactivity (mother and infant)
stress reactivity
Measured: ≤ 1 week and 6 months postpartum
heart rate variability: resting state (mother and infant)
resting state
Measured: ≤ 1 week and 6 months postpartum
heart rate variability: stress reactivity (mother and infant)
stress reactivity
Measured: ≤ 1 week and 6 months postpartum
infant behavior (mother)
Infant Behavior Questionnaire-very short form: total and subscale scores
Measured: 6 months postpartum
infant development
Bayley Scales of Infant Development (Bayley-III): clinician-rated
Measured: 6 months postpartum
mother-infant-bonding (mother)
Mother-to-Infant-Bonding Scale (MIBS): total score
Measured: ≤ 1 week, 6 weeks, 6 months postpartum
maternal emotional availability
Emotional Availability Scale: clinician-rated
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start2 Aug 2018
- Primary completion15 Dec 2021
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, University Hospital, Geneva, University of Fribourg, University of Zurich
- Responsible party
- Principal investigator, Antje Horsch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antje Horsch, D.Clin.Psych., Principal investigator, University of Lausanne and Lausanne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576586
- Sponsor's protocol ID
- 2017-02142
- Other IDs
- 2017
- Acronym
- START
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2018
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 28453969Messerli-Burgy N, Sandoz V, Deforge C, Lacroix A, Sekarski N, Horsch A. Stress responses of infants and mothers to a still-face paradigm after traumatic childbirth. Psychoneuroendocrinology. 2025 Jan;171:107222. doi: 10.1016/j.psyneuen.2024.107222. Epub 2024 Oct 16.
PubMed 39447384Deforges C, Sandoz V, Noel Y, Avignon V, Desseauve D, Bourdin J, Vial Y, Ayers S, Holmes EA, Epiney M, Horsch A. Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial. Mol Psychiatry. 2023 Sep;28(9):3842-3850. doi: 10.1038/s41380-023-02275-w. Epub 2023 Sep 27.
PubMed 37759037Sandoz 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)
- ClinicalTrials.gov ID
- NCT03576586
- Acronym / sponsor ID
- START / 2017-02142
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University of Lausanne, University Hospital, Geneva, University of Fribourg, University of Zurich
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief computerized interventionBrief computerized intervention (computer game "Tetris") plus usual care in the maternity department |
| Control | Placebo comparator | Behavioral: Attention placebo controlAttention placebo control (cognitive task for same amount of time) plus usual care in the maternity department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- if the woman agrees to participate
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief computerized interventionBrief computerized intervention (computer game "Tetris") plus usual care in the maternity department | Behavioural | Intervention |
| Attention placebo controlBrief cognitive task plus usual care in the maternity department | Behavioural | Control |
Primary outcome
presence and severity of PTSD symptoms: clinician-rated (mother)
Time frame: 6 weeks postpartum
Clinician-administered PTSD scale (CAPS): subscale and total scores
presence and severity of PTSD symptoms: self-report (mother)
Time frame: 6 weeks postpartum
PTSD Checklist (PCL-5): subscale and total scores
17 secondary outcomes
frequency of intrusive traumatic memories (mother)
Time frame: ≤ 1 week postpartum
presence and severity of ASD symptoms (mother)
Time frame: < 6 hours after ECS, ≤ 1 week postpartum
presence and severity of PTSD symptoms: self-report (mother)
Time frame: 6 months postpartum
presence and severity of PTSD symptoms: clinician-rated (mother)
Time frame: 6 months postpartum
presence and severity of anxiety symptoms (mother)
Time frame: < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum
sleep time and duration (mother)
Time frame: ≤ 1 week postpartum
sleep quantity and quality (mother)
Time frame: ≤ 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
sleep and physical activity (mother)
Time frame: ≤ 1 week and 6 months postpartum
salivary cortisol: daily profile (mother and infant)
Time frame: ≤ 1 week and 6 months postpartum
salivary cortisol: stress reactivity (mother and infant)
Time frame: ≤ 1 week and 6 months postpartum
heart rate variability: resting state (mother and infant)
Time frame: ≤ 1 week and 6 months postpartum
heart rate variability: stress reactivity (mother and infant)
Time frame: ≤ 1 week and 6 months postpartum
infant behavior (mother)
Time frame: 6 months postpartum
infant development
Time frame: 6 months postpartum
mother-infant-bonding (mother)
Time frame: ≤ 1 week, 6 weeks, 6 months postpartum
maternal emotional availability
Time frame: 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 28453969Horsch 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.
- Derived from this study: PubMed 39447384Messerli-Burgy N, Sandoz V, Deforge C, Lacroix A, Sekarski N, Horsch A. Stress responses of infants and mothers to a still-face paradigm after traumatic childbirth. Psychoneuroendocrinology. 2025 Jan;171:107222. doi: 10.1016/j.psyneuen.2024.107222. Epub 2024 Oct 16.
- Derived from this study: PubMed 37759037Deforges C, Sandoz V, Noel Y, Avignon V, Desseauve D, Bourdin J, Vial Y, Ayers S, Holmes EA, Epiney M, Horsch A. Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial. Mol Psychiatry. 2023 Sep;28(9):3842-3850. doi: 10.1038/s41380-023-02275-w. Epub 2023 Sep 27.
- Derived from this study: PubMed 31892657Sandoz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Horsch, D.Clin.Psych. principal investigator
University of Lausanne and Lausanne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief computerized intervention in people with Posttraumatic Stress Disorder and Acute Stress Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence and severity of PTSD symptoms: clinician-rated (mother) (time frame: 6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576586, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022; AzTrials last refreshed its copy on 28 Oct 2026.