Tackling Intrusive Traumatic Memories After a Difficult Birth

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

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Intrusive Traumatic Memories
• Intervention / Treatment: Behavioral: Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton De Vaud
    • Lausanne, Canton De Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence and severity of maternal PTSD symptoms	PTSD Checklist (PCL-5) for DSM-5	1 month after the intervention
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Antje Horsch
• Investigators: Principal Investigator: Antje Horsch, PhD, University of Lausanne and Lausanne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): April 14, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2019-01435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No