NCT02502513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

July 16, 2015

Last Update Submit

January 27, 2016

Conditions

Posttraumatic Stress DisorderAcute Stress Disorder

Outcome Measures

Primary Outcomes (1)

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

    1 week following the emergency cesarean section

Secondary Outcomes (3)

  • Posttraumatic Stress Diagnostic Scale (PDS)

    1 month following the emergency cesarean section

  • Acute Stress Disorder Scale (ASDS)

    1 week following the emergency cesarean section

  • Hospital Anxiety and Depression Scale (HADS)

    1 week and 1 month following the emergency cesarean section

Other Outcomes (1)

  • Acceptability of Intervention (rating scale)

    1 month following the emergency cesarean section

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Brief computerized intervention

Control

NO INTERVENTION

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

Interventions

Brief computerized interventionBEHAVIORAL

Computer game "Tetris"

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hôpital Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 28453969DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Antje Horsch, DClinPsych

    CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research psychologist

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 20, 2015

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

CH(1)