Clinical trial NCT02502513: Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section
Official title: Can Playing Tetris Prevent the Development of Traumatic Intrusions in Mothers Following an Emergency Cesarean Section? A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Acute Stress Disorder
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
name: Medical Research Council Cognition and Brain Sciences Unit
First posted: 2015-07-20
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Female, aged 18+ years
* Had emergency caesarean section within the past 6 hours
* Have given birth to a live baby at ≥ 37 weeks gestation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section
timeFrame: 1 week following the emergency cesarean section
Secondary outcomes:
measure: Posttraumatic Stress Diagnostic Scale (PDS)
timeFrame: 1 month following the emergency cesarean section
measure: Acute Stress Disorder Scale (ASDS)
timeFrame: 1 week following the emergency cesarean section
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week and 1 month following the emergency cesarean section
Other outcomes:
measure: Acceptability of Intervention (rating scale)
timeFrame: 1 month following the emergency cesarean section
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hôpital Universitaire Vaudois
state: Vaud
Study officials:
affiliation: CHUV
name: Antje Horsch, DClinPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.