Tackling Intrusive Traumatic Memories After Childbirth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2026-01-20

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.

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Detailed Description

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Conditions

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Posttraumatic Stress Disorder Intrusive Traumatic Memories

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind waitlist randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Immediate Treatment

Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.

Group Type EXPERIMENTAL

A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay

Intervention Type BEHAVIORAL

The intervention is composed of two tasks:

1. 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.
2. 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.

Waitlist

Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.

Group Type OTHER

A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay

Intervention Type BEHAVIORAL

The intervention is composed of two tasks:

1. 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.
2. 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.

Interventions

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A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay

The intervention is composed of two tasks:

1. 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.
2. 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.

Intervention Type BEHAVIORAL

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
* Being pregnant
* Perinatal loss of a child born during the index traumatic childbirth

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No