Tackling Intrusive Traumatic Memories After a Difficult Birth

NCT ID: NCT04286724

Last Updated: 2021-06-22

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

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2021-04-14

Brief Summary

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

This proof-of-principle study aims to investigate the effects of a brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic memories and other postpartum posttraumatic stress symptoms. Women who report birth-related intrusive memories after 6 weeks postpartum will monitor their intrusive traumatic memories in a daily diary. After two weeks of diary, they will meet a psychologist to briefly evoke the memory of their birth, and receive a brief behavioural procedure including playing Tetris. Participants will then continue to complete an intrusive traumatic memory diary during two weeks. It is predicted that they will report fewer intrusive memories in the two weeks following the intervention, compared to the two weeks before. This will inform the potential future development of a simple computerized intervention procedure to reduce distressing psychological symptoms after traumatic childbirth.

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 Intrusive Traumatic Memories

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group pre-post study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Intervention

Group Type EXPERIMENTAL

Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")

Intervention Type BEHAVIORAL

Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth

Interventions

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

Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")

Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Gave birth at the Lausanne University Hospital
* Gave written consent
* Have at least 4 related-to-childbirth intrusions over the two weeks prior to recruitment, and at least 2 related-to-childbirth intrusions during the pre-intervention diary
* Gave birth more than 6 weeks ago
* Is able to distinguish intrusions linked to the traumatic childbirth from intrusions linked to other traumatic events

Exclusion Criteria

* Gave birth to a stillborn child
* Not fluent in French
* Severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
* Have an established intellectual disability, or psychiatric history such as psychotic illness
* Alcohol abuse and/or illegal drug use
* Currently receiving psychological care in relation with the traumatic birth experience
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

Antje Horsch

OTHER

Sponsor Role lead

Responsible Party

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

Antje Horsch

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Antje Horsch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne and Lausanne University Hospital

Locations

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

Centre Hospitalier 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

Other Identifiers

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

2019-01435

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
PTSD Prevention Using Oral Hydrocortisone
NCT04924166 ACTIVE_NOT_RECRUITING PHASE2
TMS for PTSD and Blood Pressure
NCT05512143 ACTIVE_NOT_RECRUITING NA