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Clinical Trials/NCT05701137
NCT05701137
Completed
Not Applicable

Effectiveness of an Eye Movement Desensitization and Reprocessing (EMDR) Intervention for the Prevention of Post-traumatic Symptoms in Perinatal Loss

Hospital Clinic of Barcelona1 site in 1 country40 target enrollmentApril 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Loss
Sponsor
Hospital Clinic of Barcelona
Enrollment
40
Locations
1
Primary Endpoint
PCL-5
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

The investigators objectives is to assess the effectiveness of Eye Movement Desensitization and Reprocessing - recent traumatic episode (EMDR-RTE) as a preventive intervention for Posttraumatic Stress Disorder (PTSD) symptoms after perinatal loss.

The hypothesis is that EMDR-RTE treatment may prevent post-traumatic and depressive symptoms in women who suffered perinatal loss.

Detailed Description

Perinatal loss is a general term that refers to a loss from conception to one month postpartum. It is a grief that is still socially unauthorized, however, it is a situation with significant traumatic potential. However, there are no studies evaluating the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) for the prevention or treatment of perinatal loss. We propose an one-site, open label, randomized controlled trial with the aim of assessing the effectiveness of EMDR recent traumatic episode (EMDR-RTE) as a preventive intervention for PTSD symptoms after perinatal loss. A total of 40 women who have suffered a perinatal loss from the Maternal-Fetal Medicine Service of a tertiary university hospital will be recruited. Women will be randomized to EMDR-RTE or treatment as usual (TAU). Researchers will compare EMDR-RTE and TAU to see if women receiving EMDR-RTE treatment had lower levels of post-traumatic and depressive symptoms.

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
March 23, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • be over 18 years old
  • agree to participate and sign the informed consent
  • request psychological treatment

Exclusion Criteria

  • active substance use disorder
  • cognitive disability
  • language barrier

Outcomes

Primary Outcomes

PCL-5

Time Frame: 3 months after perinatal loss

PTSD Checklist for DSM-5

Secondary Outcomes

  • STAI S/T(3 months after perinatal loss)
  • BDI-II(3 months after perinatal loss)

Study Sites (1)

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