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

Post Traumatic Stress Disorder Clinical Trial

Official title:

Early Psychotherapeutic Intervention After Childbirth Trauma: Comparison Between EMDR and Supportive Expressive Dynamic Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03972410
• Other study ID #: EMDR 2018-04
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: University of Turin, Italy
• Contact: Sara Carletto, PhD
• Phone: 00393333308730
• Email: sara.carletto[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childbirth Problems
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• EMDR
2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol
• SEDP
2-4 sessions individual 60-min-long treatment sessions of SEDP

Locations

Country	Name	City	State
Italy	Humanitas San Pio X Hospital	Milan
Italy	San Paolo Teaching Hospital	Milan
Italy	AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital	Torino

Sponsors (3)

Lead Sponsor	Collaborator
University of Turin, Italy	Humanitas Hospital, Italy, Ospedale San Paolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mother-infant bonding	Levels of mother-infant bonding, as evaluated with Postpartum Bonding Questionnaire (PBQ)	6 weeks post-partum
Other	mother-infant bonding	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.	12 weeks post-partum
Other	anxiety symptoms	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.	6 weeks post-partum
Other	anxiety symptoms	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.	12 weeks post-partum
Primary	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.	6 weeks post-partum
Secondary	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	6 weeks post-partum
Secondary	Post-traumatic stress disorder diagnosis	proportion of patients with a diagnosis of Post-traumatic stress disorder, as assessed with Mini-International Neuropsychiatric Interview-Plus.	12 weeks post-partum
Secondary	Post-partum depression diagnosis	proportion of patients with a diagnosis of Post-partum depression, as assessed with Mini-International Neuropsychiatric Interview-Plus.	12 weeks post-partum