Preventing Childbirth-Related PTSD With Expressive Writing
ConditionPTSD (Childbirth-Related)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMassachusetts General Hospital
About this trial
The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding.
In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum (with the option of up to around Month 3 PP), participants will take part in mental health and physiological assessments, and in a brief play session with their infant.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women who recently delivered at Massachusetts General Hospital (MGH).
Women who are at risk for developing CB-PTSD based on their scoring of >16 on the Peritraumatic Distress Inventory (PDI).
Disqualifiers
Age <18 or >50.
Stillbirth.
Down's Syndrome, other serious genetic disorder in the newborn, or serious birth defect (e.g., microcephaly, spina bifida).
Admission to the neonatal intensive care unit (NICU) for more than 1 week or infant that is not medically healthy.
Trial design
Design model
Parallel
Treatments tested in this trial
Expressive Writing about Childbirth
BehavioralParticipants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.
Neutral Writing
BehavioralParticipants will write repeatedly about neutral daily events/tasks not related to childbirth.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Expressive Writing about ChildbirthActive comparator 1 intervention
Group B: Neutral WritingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Time frame
Pre-Intervention and Post-Intervention (within 1 day of treatment)2
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Time frame
Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)3
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
The posterior probability score will be determined for each participant from a composite of psychophysiological responses during script-driven imagery of recent traumatic childbirth (in comparison to baseline) that includes assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator frontalis facial muscle electromyogram (EMG) responses in microVolts. The responses to each childbirth script will then be compared with a large database of trauma-exposed subjects by means of a discriminant function analysis, which will yield a posterior probability (PrP) score (higher scores means worse outcome). The PrP scores of the two childbirth scripts will be averaged and will serve as a composite measure of physiological responsivity in the analysis.
Time frame
Month 2 postpartum (up to around Month 3 PP)4
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
The CAPS-5 is the gold-standard interview to diagnose PTSD. It yields a categorical measure of diagnosis and a severity score (scale: 0-80, higher scores means worse outcomes).
Time frame
Month 2 postpartum (up to around Month 3 PP)Secondary outcomes
1
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome). This will be assessed in relation to recent childbirth.
Time frame
Pre-Intervention and Post-Intervention (within 1 day of treatment)2
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome).This will be assessed in relation to recent childbirth.
Time frame
Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)3
Maternal Attachment Inventory (MAI) total score
The MAI self-report asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Time frame
Post-intervention (within 1 day of treatment)4
Maternal Attachment Inventory (MAI) total score
The MAI asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome).This will be assessed in relation to recent childbirth.
Time frame
Month 2 postpartum (up to around Month 3 PP)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov