Tackling Intrusive Traumatic Memories After Childbirth

Study Overview
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Brief Summary
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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.

Official Title
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tAckling intruSive Traumatic memoRies After chiLdbirth (ASTRAL): A Single-blind Waitlist Randomized Controlled Trial

Conditions
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Posttraumatic Stress Disorder, Intrusive Traumatic Memories

Intervention / Treatment
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* Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind waitlist randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15. | Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay<br>* The intervention is composed of two tasks: The childbirth narration task (8-10 min.): To trigger the malleability of the traumatic childbirth memory through memory reactivation, a psychologist will ask the participants to briefly narrate their childbirth and the moment associated with their most frequent or distressing CB-ITM. This intervention part will take place on the maternity ward to use this context as a reactivation cue. The visuospatial task (3 min. practice + 20 min. gameplay): Participants will be instructed to engage in a Tetris gameplay for 20 minutes on a handheld gaming device (Nintendo 3DS), which is assumed to disrupt memory reconsolidation. This part of the intervention will take place in a neutral room.<br>|
| Other: Waitlist<br>Participants in the waitlist control group will receive the single-session behavioral intervention on day 30. | Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay<br>* The intervention is composed of two tasks: The childbirth narration task (8-10 min.): To trigger the malleability of the traumatic childbirth memory through memory reactivation, a psychologist will ask the participants to briefly narrate their childbirth and the moment associated with their most frequent or distressing CB-ITM. This intervention part will take place on the maternity ward to use this context as a reactivation cue. The visuospatial task (3 min. practice + 20 min. gameplay): Participants will be instructed to engage in a Tetris gameplay for 20 minutes on a handheld gaming device (Nintendo 3DS), which is assumed to disrupt memory reconsolidation. This part of the intervention will take place in a neutral room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the number of maternal CB-ITM between 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 | During the 2 weeks pre- and post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention | City Birth Trauma Scale (CiBTS) | 2nd weeks pre- and post-intervention | 
| The change in the number of maternal CB-ITM between 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 | During the 2 weeks pre-intervention, and 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 | City Birth Trauma Scale (CiBTS) | 2nd week pre- and 6th week post-intervention | 
| The intervention acceptability assessed by participants from 30 to 60 days after the intervention | Acceptability questionnaire specifically designed for the study | From 30 to 60 days after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childbirth, Posttraumatic Stress Disorder, Behavioral intervention, Randomized controlled trial, Visuospatial task