Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- Centre Hospitalier Universitaire Vaudois
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- presence and severity of PTSD symptoms: self-report (mother)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Antje Horsch
Assistant Professor
Centre Hospitalier Universitaire Vaudois
Eligibility Criteria
Inclusion Criteria
- •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
- •if the woman agrees to participate
- •was present at the childbirth
- •gave written consent
Exclusion Criteria
- •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
- •don't speak French sufficiently well to participate in assessments
Outcomes
Primary Outcomes
presence and severity of PTSD symptoms: self-report (mother)
Time Frame: 6 weeks postpartum
PTSD Checklist (PCL-5): subscale and total scores
presence and severity of PTSD symptoms: clinician-rated (mother)
Time Frame: 6 weeks postpartum
Clinician-administered PTSD scale (CAPS): subscale and total scores
Secondary Outcomes
- presence and severity of ASD symptoms (mother)(< 6 hours after ECS, ≤ 1 week postpartum)
- presence and severity of PTSD symptoms: self-report (mother)(6 months postpartum)
- salivary cortisol: daily profile (mother and infant)(≤ 1 week and 6 months postpartum)
- presence and severity of depression symptoms (mother)(< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum)
- presence and severity of anxiety symptoms (mother)(< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum)
- infant behavior (mother)(6 months postpartum)
- presence and severity of PTSD symptoms: clinician-rated (mother)(6 months postpartum)
- sleep time and duration (mother)(≤ 1 week postpartum)
- frequency of intrusive traumatic memories (mother)(≤ 1 week postpartum)
- sleep quantity and quality (mother)(≤ 1 week, 6 weeks, 6 months postpartum)
- salivary cortisol: stress reactivity (mother and infant)(≤ 1 week and 6 months postpartum)
- heart rate variability: stress reactivity (mother and infant)(≤ 1 week and 6 months postpartum)
- mother-infant-bonding (mother)(≤ 1 week, 6 weeks, 6 months postpartum)
- sleep and physical activity (mother)(≤ 1 week and 6 months postpartum)
- heart rate variability: resting state (mother and infant)(≤ 1 week and 6 months postpartum)
- maternal emotional availability(6 months postpartum)
- infant development(6 months postpartum)