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Completed

NCT Number: NCT04286724

Tackling Intrusive Traumatic Memories After a Difficult Birth

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.

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Key information

Conditions

Posttraumatic Stress Disorder Intrusive Traumatic Memories Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")

Behavioral

Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth

Primary outcomes

  1. Frequency of intrusive memories of the index trauma

    Time frame: Within 2 weeks following the intervention

    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 outcomes

  1. Presence and severity of maternal PTSD symptoms

    Time frame: 1 month after the intervention

    PTSD Checklist (PCL-5) for DSM-5

  2. Frequency of intrusive memories of the index trauma

    Time frame: Between 4 and 6 weeks after the intervention

    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

  3. Psychological distress related to intrusive memories of the index trauma

    Time frame: Within 2 weeks following the intervention

    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).

Other outcomes

  1. Intervention acceptability

    Time frame: 1 month after the intervention

    10-point Likert scale (1= The intervention was not at all acceptable; 10 = The intervention was extremely acceptable).

Sponsors and collaborators

Lead sponsor

Antje Horsch

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2020
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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