Effectiveness of an EMDR Intervention for Perinatal Loss

Not Applicable

Completed

• Conditions: Pregnancy Loss; PTSD
• Interventions: Other: EMDR-RTE; Other: TAU

• Registration Number: NCT05701137
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-27
• Study Start: 2023-04-17
• Primary Completion: 2024-11-30
• Status Verified: 2025-03
• Study Completion: 2025-03-23
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMDR-RTE	EMDR-RTE	Eye movement desensitization and reprocessing in its recent traumatic episode version.
TAU	TAU	Usual treatment by a psychologist.

Primary Outcome Measures

Name	Time	Method
PCL-5	3 months after perinatal loss	PTSD Checklist for DSM-5

Secondary Outcome Measures

Name	Time	Method
STAI S/T	3 months after perinatal loss	Spielberger State/Trait Anxiety Inventory
BDI-II	3 months after perinatal loss	Beck Depression Inventory

Trial Locations

Locations (1)

Hospital Clinic sede Maternitat; 🇪🇸 Barcelona, Spain