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OpenTrials
Completed

NCT Number: NCT05701137

Effectiveness of an EMDR Intervention for 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.

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Key information

Conditions

Pregnancy Loss Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic sede Maternitat

Barcelona, 08028, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMDR-RTE

Other

The experimental group will have EMDR recent traumatic event.

TAU

Other

The comparator group will have usual psychological intervention.

Primary outcomes

  1. PCL-5

    Time frame: Within the first month after perinatal loss

    PTSD Checklist for DSM-5

  2. PCL-5

    Time frame: 3 months after perinatal loss

    PTSD Checklist for DSM-5

Secondary outcomes

  1. STAI S/T

    Time frame: Within the first month after perinatal loss

    Spielberger State/Trait Anxiety Inventory

  2. STAI S/T

    Time frame: 3 months after perinatal loss

    Spielberger State/Trait Anxiety Inventory

  3. BDI-II

    Time frame: Within the first month after perinatal loss

    Beck Depression Inventory

  4. BDI-II

    Time frame: 3 months after perinatal loss

    Beck Depression Inventory

Other outcomes

  1. Satisfaction survey

    Time frame: 3 months after perinatal loss

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • EMDR Europe

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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