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Posttraumatic Stress DisorderASTRALNCT05381155

Tackling Intrusive Traumatic Memories After Childbirth

A study testing A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay in people with Posttraumatic Stress Disorder and Intrusive Traumatic Memories, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesSwitzerland
Study dates
13 Jul 2022to 20 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Antje Horsch

    Lausanne, Canton of Vaud, 1010

  • Maxime Haubry

    Neuchâtel, Canton of Neuchâtel, 2000

Other trials in Switzerland

About this study

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

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).

Read more

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.

Being tested
A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
Keywords
Posttraumatic Stress Disorder, Childbirth, Behavioral intervention, Randomized controlled trial, Visuospatial task
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.
Study groups in NCT05381155
Study groupRoleWhat they receive
Immediate TreatmentExperimentalParticipants in the immediate treatment group will receive the single-session behavioral intervention on day 15.
Receives: Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
WaitlistOtherParticipants in the waitlist control group will receive the single-session behavioral intervention on day 30.
Receives: Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During the 2 weeks pre- and post-intervention

Secondary outcomes (4)

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

    City Birth Trauma Scale (CiBTS)

    Measured: 2nd weeks pre- and post-intervention

  2. The change in the number of maternal CB-ITM between the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention

    The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre-intervention, and during the 5th and 6th weeks post-intervention

    Measured: During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention

  3. The change in the severity of maternal CB-PTSD symptoms between the second week pre-intervention and the 6th week post-intervention

    City Birth Trauma Scale (CiBTS)

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

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

    Acceptability questionnaire specifically designed for the study

    Measured: From 30 to 60 days after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start13 Jul 2022
  3. Primary completion5 Dec 2025
  4. Study completion20 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind waitlist randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381155
Sponsor's protocol ID
2022-00652
Acronym
ASTRAL
Status last verified
Jan 2026
First submitted
13 May 2022
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD on which a publication is based will be shared in an anonymised form, at the time of the publication of the related outcomes, in an open access register.

Publications

  • 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.

    PubMed 28453969

  • 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.

    PubMed 35108604

  • 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.

    PubMed 37247964

Questions about this trial

What is this clinical trial studying?

A study testing A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay in people with Posttraumatic Stress Disorder and Intrusive Traumatic Memories, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention (time frame: During the 2 weeks pre- and post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05381155, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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