START: Swiss TrAumatic biRth Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department |
Behavioral: Brief computerized intervention
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department
|
| Placebo Comparator: Control Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department |
Behavioral: Attention placebo control
Brief cognitive task plus usual care in the maternity department
|
Outcome Measures
Primary Outcome Measures
- presence and severity of PTSD symptoms: clinician-rated (mother) [6 weeks postpartum]
Clinician-administered PTSD scale (CAPS): subscale and total scores
- presence and severity of PTSD symptoms: self-report (mother) [6 weeks postpartum]
PTSD Checklist (PCL-5): subscale and total scores
Secondary Outcome Measures
- frequency of intrusive traumatic memories (mother) [≤ 1 week postpartum]
traumatic intrusions diary
- presence and severity of ASD symptoms (mother) [< 6 hours after ECS, ≤ 1 week postpartum]
Acute Stress Disorder Scale (ASDS): subscale and total scores
- presence and severity of PTSD symptoms: self-report (mother) [6 months postpartum]
PTSD Checklist (PCL-5): subscale and total scores
- presence and severity of PTSD symptoms: clinician-rated (mother) [6 months postpartum]
Clinician-administered PTSD scale (CAPS): subscale and total scores
- presence and severity of anxiety symptoms (mother) [< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum]
anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
- sleep time and duration (mother) [≤ 1 week postpartum]
sleep diary
- sleep quantity and quality (mother) [≤ 1 week, 6 weeks, 6 months postpartum]
Pittsburgh Sleep Quality Index (PSQI): total score
- presence and severity of depression symptoms (mother) [< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum]
Edinburgh Postnatal Depression Scale (EPDS): total score
- sleep and physical activity (mother) [≤ 1 week and 6 months postpartum]
Overnight accelerometer assessments
- salivary cortisol: daily profile (mother and infant) [≤ 1 week and 6 months postpartum]
daily profile
- salivary cortisol: stress reactivity (mother and infant) [≤ 1 week and 6 months postpartum]
stress reactivity
- heart rate variability: resting state (mother and infant) [≤ 1 week and 6 months postpartum]
resting state
- heart rate variability: stress reactivity (mother and infant) [≤ 1 week and 6 months postpartum]
stress reactivity
- infant behavior (mother) [6 months postpartum]
Infant Behavior Questionnaire-very short form: total and subscale scores
- infant development [6 months postpartum]
Bayley Scales of Infant Development (Bayley-III): clinician-rated
- mother-infant-bonding (mother) [≤ 1 week, 6 weeks, 6 months postpartum]
Mother-to-Infant-Bonding Scale (MIBS): total score
- maternal emotional availability [6 months postpartum]
Emotional Availability Scale: clinician-rated
Other Outcome Measures
- morningness-eveningness (mother) [≤ 1 week postpartum]
Morningness-Eveningness Questionnaire (MEQ): total score
- social support (mother, partner) [≤ 1 week, 6 weeks, 6 months postpartum]
Modified Medical Outcomes Study Social Support Survey (MOS-8): total score
- couple relationship adjustment (mother, partner) [≤ 1 week, 6 weeks, 6 months postpartum]
Revised Dyadic Adjustment Scale (RDAS): subscale and total scores
- parenting stress (mother, partner) [6 months postpartum]
Parenting Stress Index - Short Form (PSI-SF): subscale and total scores
- post-delivery perceived stress (mother) [≤ 1 week postpartum]
Post-delivery Perceived Stress Inventory (PDPSI): subscale and total scores
- postnatal perceived stress (mother) [6 months postpartum]
Postnatal Perceived Stress Inventory (PPSI): subscale and total scores
- self-reported life events (mother, partner) [≤ 1 week and 6 months postpartum]
Life Events Questionnaire
- breastfeeding [≤ 1 week, 6 weeks, 6 months postpartum]
breastfeeding diary and questions
- Dubowitz neurologic examination (infant) [≤ 1 week postpartum]
structured clinical examination
- frequency of intrusive traumatic memories (partner) [≤ 1 week postpartum]
traumatic intrusions diary
- presence and severity of PTSD symptoms: clinician-rated (partner) [6 weeks, 6 months postpartum]
Clinician-administered PTSD scale (CAPS): subscale and total scores
- presence and severity of PTSD symptoms: self-report (partner) [6 weeks, 6 months postpartum]
PTSD Checklist (PCL-5): subscale and total scores
- presence and severity of PTSD symptoms (partner) [≤ 1 week postpartum]
Acute Stress Disorder Scale (ASDS): subscale and total scores
- presence and severity of depression symptoms (partner) [≤ 1 week, 6 weeks, 6 months postpartum]
Edinburgh Postnatal Depression Scale (EPDS): total scores
- father-infant-bonding (partner) [≤ 1 week, 6 weeks, 6 months postpartum]
Mother-to-Infant-Bonding Scale (MIBS): total score
- participant feedback questionnaire (mother) [< 6 hours after ECS]
self-report questionnaire
- treatment credibility/expectancy questionnaire (mother) [< 6 hours after ECS]
self-report questionnaire
- presence and severity of anxiety symptoms (partner) [≤ 1 week, 6 weeks, 6 months postpartum]
anxiety subscale of Hospital Anxiety and Depression Scale (HADS): subscale score
- sleep quantity and quality (partner) [≤ 1 week, 6 weeks, 6 months postpartum]
Pittsburgh Sleep Quality Index (PSQI): total score
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prof. Antje Horsch | Lausanne | Switzerland | 1010 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire Vaudois
- University of Lausanne
- University Hospital, Geneva
- University of Fribourg
- University of Zurich
Investigators
- Principal Investigator: Antje Horsch, D.Clin.Psych., University of Lausanne and Lausanne University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 2017-02142