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Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section

Primary Purpose

Posttraumatic Stress Disorder, Acute Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Brief computerized intervention
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hôpital Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department and completion of intrusive memory diary

Usual care in the maternity department plus completion of intrusive memory diary

Outcomes

Primary Outcome Measures

Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section

Secondary Outcome Measures

Posttraumatic Stress Diagnostic Scale (PDS)
Acute Stress Disorder Scale (ASDS)
Hospital Anxiety and Depression Scale (HADS)

Full Information

First Posted
July 16, 2015
Last Updated
January 27, 2016
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Lausanne Hospitals, Medical Research Council Cognition and Brain Sciences Unit
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1. Study Identification

Unique Protocol Identification Number
NCT02502513
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Lausanne Hospitals, Medical Research Council Cognition and Brain Sciences Unit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Acute Stress Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department and completion of intrusive memory diary
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care in the maternity department plus completion of intrusive memory diary
Intervention Type
Behavioral
Intervention Name(s)
Brief computerized intervention
Intervention Description
Computer game "Tetris"
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Posttraumatic Stress Diagnostic Scale (PDS)
Time Frame
1 month following the emergency cesarean section
Title
Acute Stress Disorder Scale (ASDS)
Time Frame
1 week following the emergency cesarean section
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
1 week and 1 month following the emergency cesarean section
Other Pre-specified Outcome Measures:
Title
Acceptability of Intervention (rating scale)
Time Frame
1 month following the emergency cesarean section

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antje Horsch, DClinPsych
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hôpital Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28453969
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT02080351
Description
Study investigating a related computerized intervention after a road traffic accident in a hospital Emergency Department

Learn more about this trial

Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section

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