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

NCT03972410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-17

No results posted yet for this study

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

Interventions

BEHAVIORAL

EMDR

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

BEHAVIORAL

SEDP

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

Sponsors & Collaborators

  • Ospedale San Paolo

    collaborator OTHER
  • Humanitas Hospital, Italy

    collaborator OTHER
  • University of Turin, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972410 on ClinicalTrials.gov