Posttraumatic Stress DisorderNCT02502513
Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section
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 pilot 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- 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?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Oct 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18+ years
- Had emergency caesarean section within the past 6 hours
- Have given birth to a live baby at ≥ 37 weeks gestation
Who cannot join
- Do not speak French sufficiently well to participate in assessments
- Have established intellectual disability or psychotic illness
- Baby was transferred to intensive care unit after the birth
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hôpital Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Can Playing Tetris Prevent the Development of Traumatic Intrusions in Mothers Following an Emergency Cesarean Section? A Pilot Study
This pilot 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. Patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. Participants will be followed up at one week and one month. It is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.
- Being tested
- Brief computerized intervention
- 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
Computer game "Tetris"
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department and completion of intrusive memory diary Receives: Behavioral: Brief computerized intervention |
| Control | No intervention | Usual care in the maternity department plus completion of intrusive memory diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section
Measured: 1 week following the emergency cesarean section
Secondary outcomes (3)
Posttraumatic Stress Diagnostic Scale (PDS)
Measured: 1 month following the emergency cesarean section
Acute Stress Disorder Scale (ASDS)
Measured: 1 week following the emergency cesarean section
Hospital Anxiety and Depression Scale (HADS)
Measured: 1 week and 1 month following the emergency cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, Medical Research Council Cognition and Brain Sciences Unit
- Responsible party
- Principal investigator, Antje Horsch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antje Horsch, DClinPsych, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502513
- Sponsor's protocol ID
- 480/2012
- Status last verified
- Jan 2016
- First submitted
- 16 Jul 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- 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 28453969
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Playing Tetris Prevent the Development of Traumatic Intrusions in Mothers Following an Emergency Cesarean Section? A Pilot Study
- ClinicalTrials.gov ID
- NCT02502513
- Acronym / sponsor ID
- 480/2012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, Medical Research Council Cognition and Brain Sciences Unit
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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 pilot 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. Patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. Participants will be followed up at one week and one month. It is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 and completion of intrusive memory diary |
| Control | No intervention | –Usual care in the maternity department plus completion of intrusive memory diary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female, aged 18+ years
- Had emergency caesarean section within the past 6 hours
- Have given birth to a live baby at ≥ 37 weeks gestation
Key exclusion criteria (3 listed)
- Do not speak French sufficiently well to participate in assessments
- Have established intellectual disability or psychotic illness
- Baby was transferred to intensive care unit after the birth
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 interventionComputer game "Tetris" | Behavioural | Intervention |
Primary outcome
Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section
Time frame: 1 week following the emergency cesarean section
3 secondary outcomes
Posttraumatic Stress Diagnostic Scale (PDS)
Time frame: 1 month following the emergency cesarean section
Acute Stress Disorder Scale (ASDS)
Time frame: 1 week following the emergency cesarean section
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 week and 1 month following the emergency cesarean section
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 28 Jan 2016.
- Derived from this study: 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.
- Study investigating a related computerized intervention after a road traffic accident in a hospital Emergency DepartmentLink provided by the sponsor.
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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, DClinPsych principal investigator
CHUV
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 3 inclusion and 3 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 28 Jan 2016. 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. 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?
Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section (time frame: 1 week following the emergency cesarean section). 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 NCT02502513, which also lists 1 linked publication.
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 28 Jan 2016.