Childbirth ProblemsNCT03972410
Eye Movement Desensitization and Reprocessing vs Supportive Expressive Dynamic Psychotherapy for Childbirth Trauma
A study testing EMDR and SEDP in people with Childbirth Problems and Post Traumatic Stress Disorder, run by University of Turin, Italy at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Childbirth Problems, Post Traumatic Stress Disorder
- What is being tested?
- EMDR and SEDP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- 8 Jan 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Not yet recruiting
Humanitas San Pio X Hospital
Milan
Valentina Chiorino, valentina.chiorino@gmail.com
- Not yet recruiting
San Paolo Teaching Hospital
Milan
Daniela Leone, daniela.leone@asst-santipaolocarlo.it
- Recruiting
AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital
Torino, 10126
Luca Ostacoli, M.D., 3335613155, luca.ostacoli@unito.it
About this study
Official title: Early Psychotherapeutic Intervention After Childbirth Trauma: Comparison Between EMDR and Supportive Expressive Dynamic Psychotherapy
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.
Read more
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.
Read the 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).
- Being tested
- EMDR, SEDP
- Keywords
- childbirth trauma, post-traumatic stress, depression, post-partum PTSD, EMDR, Supportive Expressive Dynamic Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol
SEDPBehavioural
2-4 sessions individual 60-min-long treatment sessions of SEDP
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) | Experimental | 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. Receives: Behavioral: EMDR |
| Supportive Expressive Dynamic Psychotherapy (SEDP) | Active comparator | 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). Receives: Behavioral: SEDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post-partum
Secondary outcomes (3)
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
Measured: 6 weeks post-partum
Post-traumatic stress disorder diagnosis
proportion of patients with a diagnosis of Post-traumatic stress disorder, as assessed with Mini-International Neuropsychiatric Interview-Plus.
Measured: 12 weeks post-partum
Post-partum depression diagnosis
proportion of patients with a diagnosis of Post-partum depression, as assessed with Mini-International Neuropsychiatric Interview-Plus.
Measured: 12 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start8 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Paolo, Humanitas Hospital, Italy
- Responsible party
- Principal investigator, luca ostacoli, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972410
- Sponsor's protocol ID
- EMDR 2018-04
- Status last verified
- Mar 2020
- First submitted
- 30 May 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Psychotherapeutic Intervention After Childbirth Trauma: Comparison Between EMDR and Supportive Expressive Dynamic Psychotherapy
- ClinicalTrials.gov ID
- NCT03972410
- Acronym / sponsor ID
- EMDR 2018-04
- Keywords
- childbirth trauma, post-traumatic stress, depression, post-partum PTSD, EMDR, Supportive Expressive Dynamic Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Ospedale San Paolo, Humanitas Hospital, Italy
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) | Experimental | Behavioral: EMDRThe 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. |
| Supportive Expressive Dynamic Psychotherapy (SEDP) | Active comparator | Behavioral: SEDPThe 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol | Behavioural | Eye Movement Desensitization and Reprocessing (EMDR) |
| SEDP2-4 sessions individual 60-min-long treatment sessions of SEDP | Behavioural | Supportive Expressive Dynamic Psychotherapy (SEDP) |
Primary outcome
Post-traumatic stress symptoms
Time frame: 6 weeks post-partum
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.
3 secondary outcomes
Post-partum depression symptoms
Time frame: 6 weeks post-partum
Post-traumatic stress disorder diagnosis
Time frame: 12 weeks post-partum
Post-partum depression diagnosis
Time frame: 12 weeks post-partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR and SEDP in people with Childbirth Problems and Post Traumatic Stress Disorder, run by University of Turin, Italy at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Carletto, PhD (00393333308730, sara.carletto@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress symptoms (time frame: 6 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.