Tackling Intrusive Traumatic Memories After a Difficult Birth

Posttraumatic Stress Disorder Clinical Trial

Official title:

Tackling Intrusive Traumatic Memories After a Difficult Birth: a proof-of Principle Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286724
• Other study ID #: 2019-01435
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: April 14, 2021

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 14, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrusive Traumatic Memories
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Canton De Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Antje Horsch

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention acceptability	10-point Likert scale (1= The intervention was not at all acceptable; 10 = The intervention was extremely acceptable).	1 month after the intervention
Primary	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	Presence and severity of maternal PTSD symptoms	PTSD Checklist (PCL-5) for DSM-5	1 month after the intervention
Secondary	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 between the 4th and 6th weeks following the intervention	Between 4 and 6 weeks after the intervention
Secondary	Psychological distress related to intrusive memories of the index trauma	Rating scale for psychological distress related to intrusive memories related to childbirth that are reported in an intrusive memories diary over the two weeks after the intervention. It is a SUDS (Subjective Units of Distress Scale) from 1 to 10 (1= No distress at all while having the intrusion ; 10 = Extreme distress while having the intrusion).	Within 2 weeks following the intervention