Clinical trial NCT05381155: Tackling Intrusive Traumatic Memories After Childbirth
Official title: tAckling intruSive Traumatic memoRies After chiLdbirth (ASTRAL): A Single-blind Waitlist Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Intrusive Traumatic Memories
Keywords: Posttraumatic Stress Disorder
Childbirth
Behavioral intervention
Randomized controlled trial
Visuospatial task
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind waitlist randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention
timeFrame: During the 2 weeks pre- and post-intervention
Secondary outcomes:
measure: The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention
timeFrame: 2nd weeks pre- and post-intervention
measure: The change in the number of maternal CB-ITM between the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention
timeFrame: During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention
measure: The change in the severity of maternal CB-PTSD symptoms between the second week pre-intervention and the 6th week post-intervention
timeFrame: 2nd week pre- and 6th week post-intervention
measure: The intervention acceptability assessed by participants from 30 to 60 days after the intervention
timeFrame: From 30 to 60 days after the intervention
Other outcomes:
measure: CB-ITM sensorial modalities, distress, nowness, and content
timeFrame: During 2-4 weeks pre-intervention, 2 weeks post-intervention, 5th and 6th weeks post-intervention
measure: Participants' autonomic response and subjective distress during the intervention procedures
timeFrame: During the intervention procedures
measure: The change in postnatal depression and anxiety symptoms between the 1st week pre-intervention and the 6th week post-intervention
timeFrame: 1st week pre- and 6th week post-intervention
measure: The change in the number of maternal CB-ITM between the 2 weeks post-intervention, and the 5th and 6th weeks post-intervention
timeFrame: During the 2 weeks post-intervention, and 5th and 6th weeks post-intervention
measure: The change in the severity of maternal CB-PTSD symptoms between the 2nd week and 6th week post-intervention
timeFrame: 2nd and 6th weeks post-intervention
Locations:
city: Lausanne
country: Switzerland
facility: Antje Horsch
state: Vaud
city: Neuchâtel
country: Switzerland
facility: Maxime Haubry
Study officials:
affiliation: University of Lausanne and Lausanne University Hospital
name: Antje Horsch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.