Clinical trial NCT04286724: Tackling Intrusive Traumatic Memories After a Difficult Birth
Official title: Tackling Intrusive Traumatic Memories After a Difficult Birth: a proof-of Principle Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Intrusive Traumatic Memories
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre-post study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of intrusive memories of the index trauma
timeFrame: Within 2 weeks following the intervention
Secondary outcomes:
measure: Presence and severity of maternal PTSD symptoms
timeFrame: 1 month after the intervention
measure: Frequency of intrusive memories of the index trauma
timeFrame: Between 4 and 6 weeks after the intervention
measure: Psychological distress related to intrusive memories of the index trauma
timeFrame: Within 2 weeks following the intervention
Other outcomes:
measure: Intervention acceptability
timeFrame: 1 month after the intervention
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Canton De Vaud
Study officials:
affiliation: University of Lausanne and Lausanne University Hospital
name: Antje Horsch, PhD
role: PRINCIPAL_INVESTIGATOR
References: