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Tackling Intrusive Traumatic Memories After Childbirth (ASTRAL)

Primary Purpose

Posttraumatic Stress Disorder, Intrusive Traumatic Memories

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Childbirth, Behavioral intervention, Randomized controlled trial, Visuospatial task

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Antje HorschRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Treatment

Waitlist

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention
City Birth Trauma Scale (CiBTS)
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
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)
The intervention acceptability assessed by participants from 30 to 60 days after the intervention
Acceptability questionnaire specifically designed for the study

Full Information

First Posted
May 13, 2022
Last Updated
May 10, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT05381155
Brief Title
Tackling Intrusive Traumatic Memories After Childbirth
Acronym
ASTRAL
Official Title
tAckling intruSive Traumatic memoRies After chiLdbirth (ASTRAL): A Single-blind Waitlist Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Intrusive Traumatic Memories
Keywords
Posttraumatic Stress Disorder, Childbirth, Behavioral intervention, Randomized controlled trial, Visuospatial task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind waitlist randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.
Arm Title
Waitlist
Arm Type
Other
Arm Description
Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.
Intervention Type
Behavioral
Intervention Name(s)
A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay
Intervention Description
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 Outcome Measure Information:
Title
The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention
Description
The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre- and post-intervention
Time Frame
During the 2 weeks pre- and post-intervention
Secondary Outcome Measure Information:
Title
The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention
Description
City Birth Trauma Scale (CiBTS)
Time Frame
2nd weeks pre- and post-intervention
Title
The change in the number of maternal CB-ITM between the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention
Description
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
Time Frame
During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention
Title
The change in the severity of maternal CB-PTSD symptoms between the second week pre-intervention and the 6th week post-intervention
Description
City Birth Trauma Scale (CiBTS)
Time Frame
2nd week pre- and 6th week post-intervention
Title
The intervention acceptability assessed by participants from 30 to 60 days after the intervention
Description
Acceptability questionnaire specifically designed for the study
Time Frame
From 30 to 60 days after the intervention
Other Pre-specified Outcome Measures:
Title
CB-ITM sensorial modalities, distress, nowness, and content
Description
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.
Time Frame
During 2-4 weeks pre-intervention, 2 weeks post-intervention, 5th and 6th weeks post-intervention
Title
Participants' autonomic response and subjective distress during the intervention procedures
Description
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).
Time Frame
During the intervention procedures
Title
The change in postnatal depression and anxiety symptoms between the 1st week pre-intervention and the 6th week post-intervention
Description
Edinburgh Postnatal Depression Scale (EPDS) and Anxiety subscale of the Hospital Anxiety and Depression scale (HADS)
Time Frame
1st week pre- and 6th week post-intervention
Title
The change in the number of maternal CB-ITM between the 2 weeks post-intervention, and the 5th and 6th weeks post-intervention
Description
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
Time Frame
During the 2 weeks post-intervention, and 5th and 6th weeks post-intervention
Title
The change in the severity of maternal CB-PTSD symptoms between the 2nd week and 6th week post-intervention
Description
City Birth Trauma Scale (CiBTS)
Time Frame
2nd and 6th weeks post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antje Horsch, PhD
Phone
+41 79 556 07 50
Email
antje.horsch@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Déborah Fort, M.Sc.
Phone
+41 79 556 73 37
Email
deborah.fort@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antje Horsch, PhD
Organizational Affiliation
University of Lausanne and Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antje Horsch
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antje Horsch, PhD
Phone
795560750
Ext
+41
Email
antje.horsch@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available at the time of the publication of the related outcomes.
IPD Sharing Access Criteria
Open access
Citations:
PubMed Identifier
28453969
Citation
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.
Results Reference
background
PubMed Identifier
35108604
Citation
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.
Results Reference
background

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Tackling Intrusive Traumatic Memories After Childbirth

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