Clinical Trials Directory

Trials / Completed

CompletedNCT05381155

Tackling Intrusive Traumatic Memories After Childbirth

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Centre Hospitalier Universitaire Vaudois · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALA single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplayThe 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.

Timeline

Start date
2022-07-13
Primary completion
2025-12-05
Completion
2026-01-20
First posted
2022-05-19
Last updated
2026-01-23

Locations

2 sites across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05381155. Inclusion in this directory is not an endorsement.