Tackling Intrusive Traumatic Memories After Childbirth

Posttraumatic Stress Disorder Clinical Trial

— ASTRAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381155
• Other study ID #: 2022-00652
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Antje Horsch, PhD
• Phone: +41 79 556 07 50
• Email: antje.horsch[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intrusive Traumatic Memories
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Antje Horsch	Lausanne	Vaud
Switzerland	Maxime Haubry	Neuchâtel

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CB-ITM sensorial modalities, distress, nowness, and content	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
Other	Participants' autonomic response and subjective distress 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).	During the intervention procedures
Other	The change in postnatal depression and anxiety symptoms between the 1st week pre-intervention and the 6th week post-intervention	Edinburgh Postnatal Depression Scale (EPDS) and Anxiety subscale of the Hospital Anxiety and Depression scale (HADS)	1st week pre- and 6th week post-intervention
Other	The change in the number of maternal CB-ITM between the 2 weeks post-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 post-intervention, and during the 5th and 6th weeks post-intervention	During the 2 weeks post-intervention, and 5th and 6th weeks post-intervention
Other	The change in the severity of maternal CB-PTSD symptoms between the 2nd week and 6th week post-intervention	City Birth Trauma Scale (CiBTS)	2nd and 6th weeks post-intervention
Primary	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	During the 2 weeks pre- and post-intervention
Secondary	The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention	City Birth Trauma Scale (CiBTS)	2nd weeks pre- and post-intervention
Secondary	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	During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention
Secondary	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)	2nd week pre- and 6th week post-intervention
Secondary	The intervention acceptability assessed by participants from 30 to 60 days after the intervention	Acceptability questionnaire specifically designed for the study	From 30 to 60 days after the intervention