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Tackling Intrusive Traumatic Memories After a Difficult Birth

Primary Purpose

Posttraumatic Stress Disorder, Intrusive Traumatic Memories

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")
Sponsored by
Antje Horsch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Presence and severity of maternal PTSD symptoms
PTSD Checklist (PCL-5) for DSM-5
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
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).

Full Information

First Posted
February 25, 2020
Last Updated
June 21, 2021
Sponsor
Antje Horsch
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1. Study Identification

Unique Protocol Identification Number
NCT04286724
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antje Horsch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Intrusive Traumatic Memories

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pre-post study
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")
Intervention Description
Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth
Primary Outcome Measure Information:
Title
Frequency of intrusive memories of the index trauma
Description
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
Time Frame
Within 2 weeks following the intervention
Secondary Outcome Measure Information:
Title
Presence and severity of maternal PTSD symptoms
Description
PTSD Checklist (PCL-5) for DSM-5
Time Frame
1 month after the intervention
Title
Frequency of intrusive memories of the index trauma
Description
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
Time Frame
Between 4 and 6 weeks after the intervention
Title
Psychological distress related to intrusive memories of the index trauma
Description
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).
Time Frame
Within 2 weeks following the intervention
Other Pre-specified Outcome Measures:
Title
Intervention acceptability
Description
10-point Likert scale (1= The intervention was not at all acceptable; 10 = The intervention was extremely acceptable).
Time Frame
1 month after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antje Horsch, PhD
Organizational Affiliation
University of Lausanne and Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Canton De Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tackling Intrusive Traumatic Memories After a Difficult Birth

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