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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment | Experimental | Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15. |
|
| Waitlist | Other | Participants in the waitlist control group will receive the single-session behavioral intervention on day 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The change in the number of maternal CB-ITM between the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antje Horsch, PhD | University of Lausanne and Lausanne University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxime Haubry | Neuchâtel | Canton of Neuchâtel | 2000 | Switzerland | ||
| Antje Horsch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28453969 | Background | 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. | |
| 35108604 | Background |
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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.
The data will be available at the time of the publication of the related outcomes.
Open access
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Single-blind waitlist randomized controlled trial
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|
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 |
| 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 |
| 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 |
| During 2-4 weeks pre-intervention, 2 weeks post-intervention, 5th and 6th weeks post-intervention |
| 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 |
| 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 |
| 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 |
| 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 |
| Lausanne |
| Canton of Vaud |
| 1010 |
| Switzerland |
| 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. |
| 37247964 | Derived | 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. |