Tackling Intrusive Traumatic Memories After Childbirth

NCT05381155 | Completed DMC

• 1 other identifier: 2022-00652
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Intrusive Traumatic Memories; Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Childbirth; Behavioral intervention; Randomized controlled trial; Visuospatial task

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention

  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

  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

  2nd week pre- and 6th week post-intervention

• The intervention acceptability assessed by participants from 30 to 60 days after the intervention

  From 30 to 60 days after the intervention

Other Outcomes (5)

• CB-ITM sensorial modalities, distress, nowness, and content

  During 2-4 weeks pre-intervention, 2 weeks post-intervention, 5th and 6th weeks post-intervention

• Participants' autonomic response and subjective distress during the intervention procedures

  During the intervention procedures

• The change in postnatal depression and anxiety symptoms between the 1st week pre-intervention and the 6th week post-intervention

  1st week pre- and 6th week post-intervention

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

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

Waitlist

OTHER

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

Interventions

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

Immediate Treatment; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (2)

Maxime Haubry

Neuchâtel, Canton of Neuchâtel, 2000, Switzerland

Location

Antje Horsch

Lausanne, Canton of Vaud, 1010, Switzerland

Location

Related Publications (3)

• Horsch A, Vial Y, Favrod C, Harari MM, Blackwell SE, Watson P, Iyadurai L, Bonsall MB, Holmes EA. Reducing intrusive traumatic memories after emergency caesarean section: A proof-of-principle randomized controlled study. Behav Res Ther. 2017 Jul;94:36-47. doi: 10.1016/j.brat.2017.03.018. Epub 2017 Apr 6.

  PMID: 28453969 BACKGROUND

• Deforges C, Fort D, Stuijfzand S, Holmes EA, Horsch A. Reducing childbirth-related intrusive memories and PTSD symptoms via a single-session behavioural intervention including a visuospatial task: A proof-of-principle study. J Affect Disord. 2022 Apr 15;303:64-73. doi: 10.1016/j.jad.2022.01.108. Epub 2022 Jan 30.

  PMID: 35108604 BACKGROUND

• Fort D, Deforges C, Messerli-Burgy N, Michael T, Baud D, Lalor J, Rimmele U, Horsch A. Tackling childbirth-related intrusive memories with a single-session behavioural intervention involving a visuospatial task: protocol for a single-blind, waitlist-controlled randomised trial. BMJ Open. 2023 May 29;13(5):e073874. doi: 10.1136/bmjopen-2023-073874.

  PMID: 37247964 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Antje Horsch, PhD

  University of Lausanne and Lausanne University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Single-blind waitlist randomized controlled trial

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 19, 2022
• Study Start: July 13, 2022
• Primary Completion: December 5, 2025
• Study Completion: January 20, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available at the time of the publication of the related outcomes.
• Access Criteria: Open access

Locations

CH (2)