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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
EMDR and SEDP
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.

Sara Carletto, PhD contact

00393333308730

sara.carletto@unito.it

Italy3 sites, 3 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

    Not yet recruiting
  • AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital

    Torino, 10126

    Luca Ostacoli, M.D., 3335613155, luca.ostacoli@unito.it

    Recruiting

Other trials in Italy

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 groups in NCT03972410
Study groupRoleWhat they receive
Eye Movement Desensitization and Reprocessing (EMDR)ExperimentalThe 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 comparatorThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted3 Jun 2019
  2. Study start8 Jan 2020
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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

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.

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