Tackling Intrusive Traumatic Memories After a Difficult Birth
1 other identifier
interventional
23
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedStudy Start
First participant enrolled
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2021
CompletedJune 22, 2021
June 1, 2021
8 months
February 25, 2020
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
EXPERIMENTALInterventions
Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth
Eligibility Criteria
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
- Antje Horschlead
Study Sites (1)
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antje Horsch, PhD
University of Lausanne and Lausanne University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- 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