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

NCT ID: NCT02502513

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder Acute Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

Brief computerized intervention

Intervention Type BEHAVIORAL

Computer game "Tetris"

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief computerized intervention

Computer game "Tetris"

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Medical Research Council Cognition and Brain Sciences Unit

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antje Horsch

Research psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antje Horsch, DClinPsych

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hôpital Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28453969 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.gov/ct2/show/NCT02080351

Study investigating a related computerized intervention after a road traffic accident in a hospital Emergency Department

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

480/2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Simple Cognitive Task After Trauma
NCT03509792 COMPLETED NA
Theta-Burst Neuromodulation for PTSD
NCT02769312 COMPLETED PHASE1/PHASE2
tDCS and Inhibitory Control in PTSD
NCT06100731 COMPLETED NA