Clinical trial NCT03972410: Eye Movement Desensitization and Reprocessing vs Supportive Expressive Dynamic Psychotherapy for Childbirth Trauma
Official title: Early Psychotherapeutic Intervention After Childbirth Trauma: Comparison Between EMDR and Supportive Expressive Dynamic Psychotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childbirth Problems
Post Traumatic Stress Disorder
Keywords: childbirth trauma
post-traumatic stress
depression
post-partum PTSD
EMDR
Supportive Expressive Dynamic Psychotherapy
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Ospedale San Paolo
name: Humanitas Hospital, Italy
First posted: 2019-06-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is increasing evidence that about 30% of women evaluate their childbirth as traumatic and that women could develop post-traumatic stress disorder (PTSD) in response to events of birth. The mean prevalence of post-partum PTSD (PP-PTSD) was reported as 3-4% in community samples and 15.7-18.95% in high-risk samples.

The primary aim is to investigate the effectiveness of Eye Movement Desesitization and Reprocessing (EMDR) in treating post-traumatic and postpartum depressive symptoms in women who had a traumatic childbirth as compared to Supportive Expressive Dynamic Psychotherapy (SEDP) as therapy as usual.

Secondary outcomes are:

* to evaluate the differences between EMDR and SEDP in preventing the onset of PTSD and Post-partum Depression after 3 months;
* to evaluate the effectiveness of EMDR and SEDP on anxiety and mother-child bonding; The subjects of the study will be 60 women who had a traumatic childbirth in the previous 2 days. Women with a Impact of Event Scale-Revised (IES-R) score \> or = to 24 will be treated with 2-4 sessions of EMDR or with SEDP.

Two follow-up assessments will be scheduled: at 6-weeks post-partum (after the end of the psychotherapeutic intervention) and at 12-weeks post-partum.

Detailed description: About 30% of women evaluate their childbirth as traumatic and 3-4% women could develop post-traumatic stress disorder (PTSD) in response to traumatic childbirth. There is also a high co-morbidity between post-traumatic stress symptoms and post-partum depressive symptoms.

The aims of the present research project are:

* to investigate the effectiveness of Eye Movement Desesitization and Reprocessing (EMDR) therapy in treating post-traumatic and post-partum depressive symptoms in women who have just experienced a traumatic childbirth as compared to Supportive Expressive Dynamic Psychotherapy (SEDP);
* to evaluate the differences between EMDR and SEDP in preventing the onset of PTSD and Post-partum Depression diagnoses after three-months post-partum;
* to evaluate the effectiveness of EMDR and SEDP on associated anxiety symptoms and on mother-child bonding both after the treatment and at the follow-up evaluation;
* to compare the effects of EMDR and SEDP on physiological indexes (i.e. HRV and skin conductance) measured during the first and last treatment sessions;
* to evaluate if these physiological indexes could predict the treatments outcome (e.g. respondents vs. non respondents).

The design of this study is a multicenter, randomized controlled clinical trial.

Patients will be consecutively recruited from three clinical centers:

* Sant'Anna Hospital, Città della Salute e della Scienza of Turin, Italy, affiliated with University of Turin, Italy.
* Humanitas San Pio X Hospital, Milan, Italy.
* San Paolo Teaching Hospital, Milan, Italy.

Participants The subjects of the study will be 60 women who have experienced a traumatic childbirth in the previous 2 days. Those who have a score on the Impact of the Event Scale - Revised (IES-R) equal or greater than 24 (in order to consider also sub threshold post-traumatic stress symptoms) will be asked for their participation in the study.

Assessments The psychological evaluation will be performed at baseline (T0), within the third day postdelivery, with a limited number of questionnaires, in order not to weigh down the patient given the context of urgency and hospitalization.

The following instruments will be administered:

* Impact of Event Scale-Revised (IES-R).
* The Edimburgh Post-natal Depression Scale (EPDS).
* Peritraumatic Dissociative Experiences Questionnaire (Marmar, 1996).

Two follow-up assessments will be scheduled in order to evaluate the outcomes of the psychotherapeutic interventions and to monitor symptoms levels over time:

* at 6-weeks post-partum (i.e. after the end of the psychotherapeutic intervention) (T1);
* at 12-weeks post- partum (T2).

During these follow-ups the following questionnaires will be administrated:

* Impact of Event Scale-Revised (IES-R);
* Edimburgh Post-natal Depression Scale (EPDS);
* Generalised Anxiety Disorder Assessment (GAD-7);
* Postpartum Bonding Questionnaire (PBQ);
* Mini-International Neuropsychiatric Interview-Plus (MINI-Plus; Sheehan et al., 1998).

Interventions All the participants, regardless of the type of treatment, will receive between 2 and 4 (according to women's availability) individual 60-min-long treatment sessions conducted over 4-5 weeks.

The first two sessions will be carried out before the woman's discharge from the maternity ward, and the next three sessions will be performed on an outpatient basis.

The EMDR treatment will follow the EMDR Recent Birth Trauma Protocol. This protocol can be used to intervene immediately after birth, or at later times. The main purposes of early intervention is to prevent the onset and development of PTSD and Postpartum Depression in the mother during the months following childbirth and to facilitate mother-newborn bonding.

The SEDP treatment is one of the most widespread treatments and can be considered the treatment as usual in Italian maternity wards. This intervention includes both supportive techniques (to create a positive, helpful and empathic relationship with the patient) and expressive techniques (aimed at helping the patient to express and to understand and change problems).

Physiological measures of psychotherapeutic process During the first and last treatment sessions, women will be asked to wear a simple wristband (similar to a wristwatch) that will monitor the physiological parameters of HRV and skin conductance for the entire duration of the session. These data will be then correlated with the outcome of the interventions detected at the follow-up assessments and with the clinical data obtained at the beginning and end of each session.

PRIMARY AND SECONDARY OUTCOMES The primary outcome of this study will be differences between EMDR and SEDP in reducing the IES- R and the EPDS clinical scores after treatment and at the 12-weeks post-partum follow-up.

Secondary outcomes of the studies are:

* to compare differences between EMDR and SEDP in preventing the onset of PTSD and Post-partum Depression diagnoses at the 12-weeks post-partum follow-up;
* to compare the effects of EMDR and SEDP on HRV and skin conductance measured during the first and last treatment sessions;
* to evaluate if these physiological indexes could predict the treatments outcome (e.g.respondents vs. non respondents).

Eligibility criteria: Inclusion Criteria:

* having experienced a traumatic childbirth (e.g. difficult delivery with obstetric and gynecological problems; woman's inability to tolerate the pain);
* a score on the lES-R \> or = 24;
* good comprehension of spoken Italian;
* legal capacity to consent to the treatment;

Exclusion Criteria:

* having a baby hospitalized in Special Care Baby Unit or Neonatal Intensive Care Unit (NICU) or with a serious, unstable medical condition; (2) having experienced a stillbirth or a live birth;
* severe suicidality, including ideation, plan, and intent;
* current serious psychological and psychiatric disorders, including psychotic disorders,bipolar disorders, active substance abuse;
* presence of overt dementia;
* a serious, unstable medical condition.

Primary outcomes:
measure: Post-traumatic stress symptoms
timeFrame: 6 weeks post-partum
Secondary outcomes:
measure: Post-partum depression symptoms
timeFrame: 6 weeks post-partum
measure: Post-traumatic stress disorder diagnosis
timeFrame: 12 weeks post-partum
measure: Post-partum depression diagnosis
timeFrame: 12 weeks post-partum
Other outcomes:
measure: mother-infant bonding
timeFrame: 6 weeks post-partum
measure: mother-infant bonding
timeFrame: 12 weeks post-partum
measure: anxiety symptoms
timeFrame: 6 weeks post-partum
measure: anxiety symptoms
timeFrame: 12 weeks post-partum
Locations:
city: Milan
country: Italy
facility: Humanitas San Pio X Hospital
city: Milan
country: Italy
facility: San Paolo Teaching Hospital
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital
Study officials:
References: