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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
| University Hospital, Geneva | OTHER |
| University of Fribourg | OTHER |
| University of Zurich |
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This randomized controlled study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section (ECS). Women who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention plus usual care or an attention placebo control group plus usual care within the first 6 hours following the ECS. Women and their infants will be followed up at ≤ 1 week postpartum, 6 weeks postpartum, and 6 months postpartum. It is predicted that women given the brief computerized intervention will develop fewer intrusive memories and less posttraumatic stress symptoms than those who are not. This will inform the development of a simple computerized early intervention to prevent distressing psychological symptoms after a traumatic event, such as an ECS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department |
|
| Control | Placebo Comparator | Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief computerized intervention | Behavioral | Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department |
|
| Measure | Description | Time Frame |
|---|---|---|
| presence and severity of PTSD symptoms: clinician-rated (mother) | Clinician-administered PTSD scale (CAPS): subscale and total scores | 6 weeks postpartum |
| presence and severity of PTSD symptoms: self-report (mother) | PTSD Checklist (PCL-5): subscale and total scores | 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of intrusive traumatic memories (mother) | traumatic intrusions diary | ≤ 1 week postpartum |
| presence and severity of ASD symptoms (mother) | Acute Stress Disorder Scale (ASDS): subscale and total scores |
| Measure | Description | Time Frame |
|---|---|---|
| morningness-eveningness (mother) | Morningness-Eveningness Questionnaire (MEQ): total score | ≤ 1 week postpartum |
| social support (mother, partner) | Modified Medical Outcomes Study Social Support Survey (MOS-8): total score |
Inclusion Criteria:
Women:
Partners:
Exclusion Criteria:
Women:
Partner:
- don't speak French sufficiently well to participate in assessments
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| Name | Affiliation | Role |
|---|---|---|
| Antje Horsch, D.Clin.Psych. | University of Lausanne and Lausanne University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Antje Horsch | Lausanne | 1010 | Switzerland |
| 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. | |
| 37759037 | Derived |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D040701 | Stress Disorders, Traumatic, Acute |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| OTHER |
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| Attention placebo control | Behavioral | Brief cognitive task plus usual care in the maternity department |
|
| < 6 hours after ECS, ≤ 1 week postpartum |
| presence and severity of PTSD symptoms: self-report (mother) | PTSD Checklist (PCL-5): subscale and total scores | 6 months postpartum |
| presence and severity of PTSD symptoms: clinician-rated (mother) | Clinician-administered PTSD scale (CAPS): subscale and total scores | 6 months postpartum |
| presence and severity of anxiety symptoms (mother) | anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score | < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum |
| sleep time and duration (mother) | sleep diary | ≤ 1 week postpartum |
| sleep quantity and quality (mother) | Pittsburgh Sleep Quality Index (PSQI): total score | ≤ 1 week, 6 weeks, 6 months postpartum |
| presence and severity of depression symptoms (mother) | Edinburgh Postnatal Depression Scale (EPDS): total score | < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum |
| sleep and physical activity (mother) | Overnight accelerometer assessments | ≤ 1 week and 6 months postpartum |
| salivary cortisol: daily profile (mother and infant) | daily profile | ≤ 1 week and 6 months postpartum |
| salivary cortisol: stress reactivity (mother and infant) | stress reactivity | ≤ 1 week and 6 months postpartum |
| heart rate variability: resting state (mother and infant) | resting state | ≤ 1 week and 6 months postpartum |
| heart rate variability: stress reactivity (mother and infant) | stress reactivity | ≤ 1 week and 6 months postpartum |
| infant behavior (mother) | Infant Behavior Questionnaire-very short form: total and subscale scores | 6 months postpartum |
| infant development | Bayley Scales of Infant Development (Bayley-III): clinician-rated | 6 months postpartum |
| mother-infant-bonding (mother) | Mother-to-Infant-Bonding Scale (MIBS): total score | ≤ 1 week, 6 weeks, 6 months postpartum |
| maternal emotional availability | Emotional Availability Scale: clinician-rated | 6 months postpartum |
| ≤ 1 week, 6 weeks, 6 months postpartum |
| couple relationship adjustment (mother, partner) | Revised Dyadic Adjustment Scale (RDAS): subscale and total scores | ≤ 1 week, 6 weeks, 6 months postpartum |
| parenting stress (mother, partner) | Parenting Stress Index - Short Form (PSI-SF): subscale and total scores | 6 months postpartum |
| post-delivery perceived stress (mother) | Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores | ≤ 1 week postpartum |
| postnatal perceived stress (mother) | Postnatal Perceived Stress Inventory (PPSI): subscale and total scores | 6 months postpartum |
| self-reported life events (mother, partner) | Life Events Questionnaire | ≤ 1 week and 6 months postpartum |
| breastfeeding | breastfeeding diary and questions | ≤ 1 week, 6 weeks, 6 months postpartum |
| Dubowitz neurologic examination (infant) | structured clinical examination | ≤ 1 week postpartum |
| frequency of intrusive traumatic memories (partner) | traumatic intrusions diary | ≤ 1 week postpartum |
| presence and severity of PTSD symptoms: clinician-rated (partner) | Clinician-administered PTSD scale (CAPS): subscale and total scores | 6 weeks, 6 months postpartum |
| presence and severity of PTSD symptoms: self-report (partner) | PTSD Checklist (PCL-5): subscale and total scores | 6 weeks, 6 months postpartum |
| presence and severity of PTSD symptoms (partner) | Acute Stress Disorder Scale (ASDS): subscale and total scores | ≤ 1 week postpartum |
| presence and severity of depression symptoms (partner) | Edinburgh Postnatal Depression Scale (EPDS): total scores | ≤ 1 week, 6 weeks, 6 months postpartum |
| father-infant-bonding (partner) | Mother-to-Infant-Bonding Scale (MIBS): total score | ≤ 1 week, 6 weeks, 6 months postpartum |
| participant feedback questionnaire (mother) | self-report questionnaire | < 6 hours after ECS |
| treatment credibility/expectancy questionnaire (mother) | self-report questionnaire | < 6 hours after ECS |
| presence and severity of anxiety symptoms (partner) | anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score | ≤ 1 week, 6 weeks, 6 months postpartum |
| sleep quantity and quality (partner) | Pittsburgh Sleep Quality Index (PSQI): total score | ≤ 1 week, 6 weeks, 6 months postpartum |
| Deforges C, Sandoz V, Noel Y, Avignon V, Desseauve D, Bourdin J, Vial Y, Ayers S, Holmes EA, Epiney M, Horsch A. Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial. Mol Psychiatry. 2023 Sep;28(9):3842-3850. doi: 10.1038/s41380-023-02275-w. Epub 2023 Sep 27. |
| 31892657 | Derived | Sandoz V, Deforges C, Stuijfzand S, Epiney M, Vial Y, Sekarski N, Messerli-Burgy N, Ehlert U, Bickle-Graz M, Morisod Harari M, Porcheret K, Schechter DS, Ayers S, Holmes EA, Horsch A; START Research Consortium. Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START). BMJ Open. 2019 Dec 30;9(12):e032469. doi: 10.1136/bmjopen-2019-032469. |