NCT05701137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2025

Completed
Last Updated

July 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

December 19, 2022

Last Update Submit

July 1, 2025

Conditions

Pregnancy LossPTSD

Keywords

perinatal lossPTSDEMDR

Outcome Measures

Primary Outcomes (2)

  • PCL-5

    PTSD Checklist for DSM-5

    Within the first month after perinatal loss

  • PCL-5

    PTSD Checklist for DSM-5

    3 months after perinatal loss

Secondary Outcomes (4)

  • STAI S/T

    Within the first month after perinatal loss

  • STAI S/T

    3 months after perinatal loss

  • BDI-II

    Within the first month after perinatal loss

  • BDI-II

    3 months after perinatal loss

Other Outcomes (1)

  • Satisfaction survey

    3 months after perinatal loss

Study Arms (2)

EMDR-RTE

EXPERIMENTAL

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

Other: EMDR-RTE

TAU

ACTIVE COMPARATOR

Usual treatment by a psychologist.

Other: TAU

Interventions

EMDR-RTEOTHER

The experimental group will have EMDR recent traumatic event.

EMDR-RTE
TAUOTHER

The comparator group will have usual psychological intervention.

TAU

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • active substance use disorder
  • cognitive disability
  • language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic sede Maternitat

Barcelona, Barcelona, 08028, Spain

Location

Related Publications (1)

  • 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.

    PMID: 40551815BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2022

First Posted

January 27, 2023

Study Start

April 17, 2023

Primary Completion

November 30, 2024

Study Completion

March 23, 2025

Last Updated

July 4, 2025

Record last verified: 2025-03

Locations

ES(1)