Effectiveness of an EMDR Intervention for Perinatal Loss

NCT ID: NCT05701137

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2025-03-23

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.

Conditions

Pregnancy Loss; PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

EMDR-RTE

Eye movement desensitization and reprocessing in its recent traumatic episode version.

Group Type: EXPERIMENTAL

EMDR-RTE

Intervention Type: OTHER

The experimental group will have EMDR recent traumatic event.

TAU

Usual treatment by a psychologist.

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: OTHER

The comparator group will have usual psychological intervention.

Interventions

EMDR-RTE

The experimental group will have EMDR recent traumatic event.

Intervention Type: OTHER

TAU

The comparator group will have usual psychological intervention.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EMDR Europe

INDUSTRY

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clinic sede Maternitat

Barcelona, Barcelona, Spain

Countries

Spain

References

Sureda-Caldentey B, Garcia-Gibert C, Martinez A, Gimenez Y, Segu X, Mallorqui A, Gelabert E, Roca-Lecumberri A, Torres-Gimenez A. Effectiveness of an eye movement desensitization and reprocessing intervention for the prevention of post- traumatic symptoms in perinatal loss: a randomized pilot controlled trial. Front Psychiatry. 2025 Jun 9;16:1593306. doi: 10.3389/fpsyt.2025.1593306. eCollection 2025.

Reference Type: BACKGROUND

PMID: 40551815 (View on PubMed)

Other Identifiers

2022-03

Identifier Type: -

Identifier Source: org_study_id