Tackling Intrusive Traumatic Memories After Childbirth

Not Applicable

Recruiting

• Conditions: Posttraumatic Stress Disorder; Intrusive Traumatic Memories
• Interventions: Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay

• Registration Number: NCT05381155
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

This single-blind waitlist randomized controlled trial aims to investigate the efficacy of a single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a visuospatial task (the computer game "Tetris"), on childbirth-related intrusive traumatic memories (CB-ITM) and other childbirth-related posttraumatic stress disorder (CB-PTSD) symptoms. Women who report CB-ITM after 6 weeks postpartum can be included in the study. Participants will be randomly allocated to either the immediate treatment (IT) group or to the waitlist (WL) group.

Women in the IT group will first report their CB-ITM in a daily diary during 2 weeks (diary 1). On the 15th day, they will meet a psychologist to receive the single-session behavioral intervention. They will then complete a daily diary during the 2 weeks post-intervention (diary 2) and during the 5th and 6th weeks post-intervention (diary 3).

Women in the WL group will report their CB-ITM continuously during 4 weeks in diary 1 and 2 before receiving the same intervention on the 30th day. They will also complete a last diary during the 2 weeks post-intervention (diary 3).

It is expected that women in the immediate treatment group (IT group) will have fewer CB-ITM in diary 2, in comparison to the WL group, for which we expect no significant change in the number of CB-ITM between diary 1 and 2.

This study will contribute to the development of a single-session behavioral intervention to reduce CB-ITMs and other CB-PTSD symptoms, which would reduce the distress experienced by mothers and may improve the well-being of the whole family.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-19
• Study Start: 2022-07-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Signed written consent
• Gave birth in one of the study centres
• Gave birth to a live baby
• Had at least 4 CB-ITM over the past two weeks
• Childbirth happened at least 6 weeks ago

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Exclusion Criteria

• Is not fluent enough in French to participate in the assessments
• Life-threatening illness of mother or infant
• Has an established intellectual disability or a psychotic illness
• Takes propranolol medication
• Alcohol and/or illicit drug abuse
• Is not able to distinguish ITM linked to other traumatic events from CB-ITM targeted during the intervention
• Has an ongoing psychological treatment in relation to her childbirth experience
• Is under 18 years old

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Treatment	A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay	Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.
Waitlist	A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay	Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.

Primary Outcome Measures

Name	Time	Method
The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention	During the 2 weeks pre- and post-intervention	The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre- and post-intervention

Secondary Outcome Measures

Name	Time	Method
The intervention acceptability assessed by participants from 30 to 60 days after the intervention	From 30 to 60 days after the intervention	Acceptability questionnaire specifically designed for the study
The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention	2nd weeks pre- and post-intervention	City Birth Trauma Scale (CiBTS)
The change in the number of maternal CB-ITM between the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention	During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention	The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre-intervention, and during the 5th and 6th weeks post-intervention
The change in the severity of maternal CB-PTSD symptoms between the second week pre-intervention and the 6th week post-intervention	2nd week pre- and 6th week post-intervention	City Birth Trauma Scale (CiBTS)

Trial Locations

Locations (2)

Maxime Haubry; 🇨🇭 Neuchâtel, Switzerland

Antje Horsch; 🇨🇭 Lausanne, Vaud, Switzerland