Effectiveness of an EMDR Intervention for Perinatal Loss

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701137
• Other study ID #: 2022-03
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2024
• Source: Hospital Clinic of Barcelona
• Contact: Anna Torres
• Phone: +34 932279948
• Email: atorresg[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Loss
• PTSD

Intervention

Other:
• EMDR-RTE
The experimental group will have EMDR recent traumatic event.
• TAU
The comparator group will have usual psychological intervention.

Locations

Country	Name	City	State
Spain	Hospital Clinic sede Maternitat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	EMDR Europe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction survey		3 months after perinatal loss
Primary	PCL-5	PTSD Checklist for DSM-5	Within the first month after perinatal loss
Primary	PCL-5	PTSD Checklist for DSM-5	3 months after perinatal loss
Secondary	STAI S/T	Spielberger State/Trait Anxiety Inventory	Within the first month after perinatal loss
Secondary	STAI S/T	Spielberger State/Trait Anxiety Inventory	3 months after perinatal loss
Secondary	BDI-II	Beck Depression Inventory	Within the first month after perinatal loss
Secondary	BDI-II	Beck Depression Inventory	3 months after perinatal loss