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NCT Number: NCT05381155

Tackling Intrusive Traumatic Memories After Childbirth

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maxime Haubry, Neuchâtel, Canton of Neuchâtel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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.
  • 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.

Primary outcomes

  1. 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

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

Secondary outcomes

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

    Time frame: 2nd weeks pre- and post-intervention

    City Birth Trauma Scale (CiBTS)

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

    Time frame: During 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

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

    Time frame: 2nd week pre- and 6th week post-intervention

    City Birth Trauma Scale (CiBTS)

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

    Time frame: From 30 to 60 days after the intervention

    Acceptability questionnaire specifically designed for the study

Other outcomes

  1. CB-ITM sensorial modalities, distress, nowness, and content

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

    Report of the sensorial modalities (visual, auditory, gustatory, olfactive, proprioceptive, tactile, and nociceptive) associated to the CB-ITM reported in the diary.

    Rating scale for psychological distress related to the CB-ITM that are reported in the diary on a scale ranging from 0 to 10 (0 = No distress at all while having the intrusion ; 10 = Extreme distress while having the intrusion).

    Rating scale of how much participants had the "impression that the memory was happening here and now" on a scale from 0 to 10 (0 = Not at all ; 10 = Extremely) while having the CB-ITM.

    Brief description of the content of the CB-ITM in the diary.

  2. Participants' autonomic response and subjective distress during the intervention procedures

    Time frame: During the intervention procedures

    Autonomic response assessed via heart rate monitor during the intervention procedures.

    Rating scale for psychological distress assessed several times during the intervention using a Visual Analogue Scale of subjective distress going from 0 to 10 (0 = Not at all stressed and/or anxious ; 10 = Extremely stressed and/or anxious).

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

    Time frame: 1st week pre- and 6th week post-intervention

    Edinburgh Postnatal Depression Scale (EPDS) and Anxiety subscale of the Hospital Anxiety and Depression scale (HADS)

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

    Time frame: During the 2 weeks post-intervention, and 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 post-intervention, and during the 5th and 6th weeks post-intervention

  5. The change in the severity of maternal CB-PTSD symptoms between the 2nd week and 6th week post-intervention

    Time frame: 2nd and 6th weeks post-intervention

    City Birth Trauma Scale (CiBTS)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: ASTRAL

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 19, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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