- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381155
Tackling Intrusive Traumatic Memories After Childbirth (ASTRAL)
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).
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Canton of Neuchâtel
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Neuchâtel, Canton of Neuchâtel, Switzerland, 2000
- Maxime Haubry
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Canton of Vaud
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Lausanne, Canton of Vaud, Switzerland, 1010
- Antje Horsch
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Immediate Treatment
Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.
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The intervention is composed of two tasks:
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Other: Waitlist
Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.
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The intervention is composed of two tasks:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre- and post-intervention
|
During the 2 weeks pre- and post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The intervention acceptability assessed by participants from 30 to 60 days after the intervention
Time Frame: From 30 to 60 days after the intervention
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Acceptability questionnaire specifically designed for the study
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From 30 to 60 days after the intervention
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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
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City Birth Trauma Scale (CiBTS)
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2nd weeks pre- and post-intervention
|
|
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
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During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention
|
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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
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City Birth Trauma Scale (CiBTS)
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2nd week pre- and 6th week post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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. |
During 2-4 weeks pre-intervention, 2 weeks post-intervention, 5th and 6th weeks post-intervention
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Participants' autonomic response and subjective distress during the intervention procedures
Time Frame: During the intervention procedures
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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). |
During the intervention procedures
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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
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Edinburgh Postnatal Depression Scale (EPDS) and Anxiety subscale of the Hospital Anxiety and Depression scale (HADS)
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1st week pre- and 6th week post-intervention
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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
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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
|
During the 2 weeks post-intervention, and 5th and 6th weeks post-intervention
|
|
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)
|
2nd and 6th weeks post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antje Horsch, PhD, University of Lausanne and Lausanne University Hospital
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-00652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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