Swiss TrAumatic biRth Trial

Study Overview
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Brief Summary
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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.

Official Title
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Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)

Conditions
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Posttraumatic Stress Disorder, Acute Stress Disorder

Intervention / Treatment
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* Behavioral: Brief computerized intervention
* Behavioral: Attention placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women: had an ECS at ≥ 34 weeks gestation gave birth to a live baby answered with a score of ≥ 2 separately for at least two out of four screening questions regarding perceived threat gave written consent Partners: if the woman agrees to participate was present at the childbirth gave written consent Exclusion Criteria: Women: don't speak French sufficiently well to participate in assessments have an established intellectual disability or psychotic illness severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations) infant requires intensive care alcohol abuse and/or illegal drug use during pregnancy Partner: - don't speak French sufficiently well to participate in assessments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Brief computerized intervention (computer game Tetris) plus usual care in the maternity department | Behavioral: Brief computerized intervention<br>* Brief computerized intervention (computer game Tetris) plus usual care in the maternity department<br>|
| Placebo Comparator: Control<br>Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department | Behavioral: Attention placebo control<br>* Brief cognitive task plus usual care in the maternity department<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | < 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 |