ASTRAL: Tackling Intrusive Traumatic Memories After Childbirth

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Recruiting
CT.gov ID
NCT05381155
Collaborator
(none)
120
1
2
29.6
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blind waitlist randomized controlled trialSingle-blind waitlist randomized controlled trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
tAckling intruSive Traumatic memoRies After chiLdbirth (ASTRAL): A Single-blind Waitlist Randomized Controlled Trial
Actual Study Start Date :
Jul 13, 2022
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate Treatment

Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.

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

Other: Waitlist

Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.

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

Outcome Measures

Primary Outcome Measures

  1. The number of maternal CB-ITM during the two weeks following the intervention [During the two weeks following the intervention]

    The number of intrusive traumatic memories related to childbirth reported by participants in a diary over the two weeks after the intervention

Secondary Outcome Measures

  1. The severity of maternal CB-PTSD symptoms at 2 weeks post-intervention [At 2 weeks post-intervention]

    City Birth Trauma Scale (CiBTS)

  2. The number of maternal CB-ITM during the 5th and 6th weeks post-intervention [During the 5th and 6th weeks post-intervention]

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

  3. The severity of maternal CB-PTSD symptoms 6 weeks after the intervention [6 weeks after the intervention]

    City Birth Trauma Scale (CiBTS)

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

    Acceptability questionnaire specifically designed for the study

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Signed written consent

  • Gave birth at the Lausanne University Hospital (CHUV)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antje Horsch Lausanne Vaud Switzerland 1010

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Antje Horsch, PhD, University of Lausanne and Lausanne University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Antje Horsch, Associate professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT05381155
Other Study ID Numbers:
  • 2022-00652
First Posted:
May 19, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antje Horsch, Associate professor, Centre Hospitalier Universitaire Vaudois
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022