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Eye Movement Desensitization and Reprocessing vs Supportive Expressive Dynamic Psychotherapy for Childbirth Trauma

Primary Purpose

Childbirth Problems, Post Traumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EMDR
SEDP
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childbirth Problems focused on measuring childbirth trauma, post-traumatic stress, depression, post-partum PTSD, EMDR, Supportive Expressive Dynamic Psychotherapy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Humanitas San Pio X Hospital
  • San Paolo Teaching Hospital
  • AOU Città della Salute e della Scienza di Torino - Sant'Anna HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eye Movement Desensitization and Reprocessing (EMDR)

Supportive Expressive Dynamic Psychotherapy (SEDP)

Arm Description

The EMDR treatment will follow the EMDR Recent Birth Trauma Protocol. This protocol was recently developed by some of the colleagues collaborating in this research project (Catteneo et al., 2018). This EMDR 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 Post-partum Depression in the mother during the months following childbirth and to facilitate mother-newborn bonding.

The SEDP treatment (Luborsky 1984; Book, 1998) 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).

Outcomes

Primary Outcome Measures

Post-traumatic stress symptoms
Reduction of post-traumatic stress symptoms, as assessed by Impact of Event Scale -Revised (IES-R). Total score range 0-88. Cut-off for presence post-traumatic symptoms>=33.

Secondary Outcome Measures

Post-partum depression symptoms
Reduction of post-partum depressive symptoms, as assessed by Edimburgh Post-natal Depression Scale (EPDS). Total score range: 0-30, cut-off score for possible depression =8. Possible Depression: 10 or greater
Post-traumatic stress disorder diagnosis
proportion of patients with a diagnosis of Post-traumatic stress disorder, as assessed with Mini-International Neuropsychiatric Interview-Plus.
Post-partum depression diagnosis
proportion of patients with a diagnosis of Post-partum depression, as assessed with Mini-International Neuropsychiatric Interview-Plus.

Full Information

First Posted
May 30, 2019
Last Updated
March 14, 2020
Sponsor
University of Turin, Italy
Collaborators
Ospedale San Paolo, Humanitas Hospital, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03972410
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
Collaborators
Ospedale San Paolo, Humanitas Hospital, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childbirth Problems, Post Traumatic Stress Disorder
Keywords
childbirth trauma, post-traumatic stress, depression, post-partum PTSD, EMDR, Supportive Expressive Dynamic Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eye Movement Desensitization and Reprocessing (EMDR)
Arm Type
Experimental
Arm Description
The EMDR treatment will follow the EMDR Recent Birth Trauma Protocol. This protocol was recently developed by some of the colleagues collaborating in this research project (Catteneo et al., 2018). This EMDR 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 Post-partum Depression in the mother during the months following childbirth and to facilitate mother-newborn bonding.
Arm Title
Supportive Expressive Dynamic Psychotherapy (SEDP)
Arm Type
Active Comparator
Arm Description
The SEDP treatment (Luborsky 1984; Book, 1998) 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).
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol
Intervention Type
Behavioral
Intervention Name(s)
SEDP
Intervention Description
2-4 sessions individual 60-min-long treatment sessions of SEDP
Primary Outcome Measure Information:
Title
Post-traumatic stress symptoms
Description
Reduction of post-traumatic stress symptoms, as assessed by Impact of Event Scale -Revised (IES-R). Total score range 0-88. Cut-off for presence post-traumatic symptoms>=33.
Time Frame
6 weeks post-partum
Secondary Outcome Measure Information:
Title
Post-partum depression symptoms
Description
Reduction of post-partum depressive symptoms, as assessed by Edimburgh Post-natal Depression Scale (EPDS). Total score range: 0-30, cut-off score for possible depression =8. Possible Depression: 10 or greater
Time Frame
6 weeks post-partum
Title
Post-traumatic stress disorder diagnosis
Description
proportion of patients with a diagnosis of Post-traumatic stress disorder, as assessed with Mini-International Neuropsychiatric Interview-Plus.
Time Frame
12 weeks post-partum
Title
Post-partum depression diagnosis
Description
proportion of patients with a diagnosis of Post-partum depression, as assessed with Mini-International Neuropsychiatric Interview-Plus.
Time Frame
12 weeks post-partum
Other Pre-specified Outcome Measures:
Title
mother-infant bonding
Description
Levels of mother-infant bonding, as evaluated with Postpartum Bonding Questionnaire (PBQ)
Time Frame
6 weeks post-partum
Title
mother-infant bonding
Description
Levels of mother-infant bonding, as evaluated with Postpartum Bonding Questionnaire (PBQ). The PBQ has four subscales which reflect impaired bonding (Scale 1) (12 items, ranging from 0 to 60), rejection and anger (Scale 2) (7 items, scores ranging from 0 to 35), anxiety about care (Scale 3) (4 items,scores ranging from 0 to 20) and risk of abuse (Scale 4) (2 items,scores ranging from 0 to 10). Brockington et al. (2001) suggest cut-off scores to identify problematic bonding of 12 for Scale 1, 17 for Scale 2, 10 for Scale 3 and 3 for Scale 4.
Time Frame
12 weeks post-partum
Title
anxiety symptoms
Description
levels of anxiety symptoms, as evalueated with Generalized Anxiety Disorder Assessment (GAD-7). Total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Time Frame
6 weeks post-partum
Title
anxiety symptoms
Description
levels of anxiety symptoms, as evalueated with Generalized Anxiety Disorder Assessment (GAD-7). Total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Time Frame
12 weeks post-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Carletto, PhD
Phone
00393333308730
Email
sara.carletto@unito.it
Facility Information:
Facility Name
Humanitas San Pio X Hospital
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Chiorino
Email
valentina.chiorino@gmail.com
Facility Name
San Paolo Teaching Hospital
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Leone
Email
daniela.leone@asst-santipaolocarlo.it
Facility Name
AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ostacoli, M.D.
Phone
3335613155
Email
luca.ostacoli@unito.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Eye Movement Desensitization and Reprocessing vs Supportive Expressive Dynamic Psychotherapy for Childbirth Trauma

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