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

NCT03972410 | Unknown

• 1 other identifier: EMDR 2018-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Childbirth Problems; Post Traumatic Stress Disorder

Keywords

childbirth trauma; post-traumatic stress; depression; post-partum PTSD; EMDR; Supportive Expressive Dynamic Psychotherapy

Outcome Measures

Primary Outcomes (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.

  6 weeks post-partum

Secondary Outcomes (3)

• Post-partum depression symptoms

  6 weeks post-partum

• Post-traumatic stress disorder diagnosis

  12 weeks post-partum

• Post-partum depression diagnosis

  12 weeks post-partum

Other Outcomes (4)

• mother-infant bonding

  6 weeks post-partum

• mother-infant bonding

  12 weeks post-partum

• anxiety symptoms

  6 weeks post-partum

Study Arms (2)

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.

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).

Behavioral: SEDP

Interventions

EMDR BEHAVIORAL

2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol

Eye Movement Desensitization and Reprocessing (EMDR)

SEDP BEHAVIORAL

2-4 sessions individual 60-min-long treatment sessions of SEDP

Supportive Expressive Dynamic Psychotherapy (SEDP)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead
• Ospedale San Paolo: collaborator
• Humanitas Hospital, Italy: collaborator

Study Sites (3)

Humanitas San Pio X Hospital

Milan, Italy

NOT YET RECRUITING

San Paolo Teaching Hospital

Milan, Italy

NOT YET RECRUITING

AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sara Carletto, PhD

CONTACT

00393333308730; sara.carletto@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of clinical psychology

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: January 8, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)