NCT04286724

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

February 25, 2020

Last Update Submit

June 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of intrusive memories of the index trauma

    Frequency of intrusive traumatic memories related to childbirth recorded by participants in a trauma-related intrusive memories diary over the two weeks after the intervention

    Within 2 weeks following the intervention

Secondary Outcomes (3)

  • Presence and severity of maternal PTSD symptoms

    1 month after the intervention

  • Frequency of intrusive memories of the index trauma

    Between 4 and 6 weeks after the intervention

  • Psychological distress related to intrusive memories of the index trauma

    Within 2 weeks following the intervention

Other Outcomes (1)

  • Intervention acceptability

    1 month after the intervention

Study Arms (1)

Intervention

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

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Antje Horsch, PhD

    University of Lausanne and Lausanne University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group pre-post study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

July 8, 2020

Primary Completion

March 15, 2021

Study Completion

April 14, 2021

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations