Effectiveness of an EMDR Intervention for Perinatal Loss

July 1, 2025 updated by: Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Hospital Clinic sede Maternitat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMDR-RTE
Eye movement desensitization and reprocessing in its recent traumatic episode version.
Other: EMDR-RTE
The experimental group will have EMDR recent traumatic event.
Active Comparator: TAU
Usual treatment by a psychologist.
Other: TAU
The comparator group will have usual psychological intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCL-5
Time Frame: Within the first month after perinatal loss
PTSD Checklist for DSM-5
Within the first month after perinatal loss
PCL-5
Time Frame: 3 months after perinatal loss
PTSD Checklist for DSM-5
3 months after perinatal loss

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STAI S/T
Time Frame: Within the first month after perinatal loss
Spielberger State/Trait Anxiety Inventory
Within the first month after perinatal loss
STAI S/T
Time Frame: 3 months after perinatal loss
Spielberger State/Trait Anxiety Inventory
3 months after perinatal loss
BDI-II
Time Frame: Within the first month after perinatal loss
Beck Depression Inventory
Within the first month after perinatal loss
BDI-II
Time Frame: 3 months after perinatal loss
Beck Depression Inventory
3 months after perinatal loss

Other Outcome Measures

Outcome Measure
Time Frame
Satisfaction survey
Time Frame: 3 months after perinatal loss
3 months after perinatal loss

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

EMDR Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

March 23, 2025

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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