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Tackling Intrusive Traumatic Memories After Childbirth (ASTRAL)

V

Vaud University Hospital Center

Status

Completed

Conditions

Posttraumatic Stress Disorder
Intrusive Traumatic Memories

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05381155
2022-00652

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Immediate Treatment
Experimental group
Description:
Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.
Treatment:
Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
Waitlist
Other group
Description:
Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.
Treatment:
Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay

Trial contacts and locations

2

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Central trial contact

Déborah Fort, M.Sc.; Antje Horsch, PhD

Data sourced from clinicaltrials.gov

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