Effectiveness of an EMDR Intervention for Perinatal Loss

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701137

Collaborator

EMDR Europe (Industry)

Enrollment

Arms

21.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Loss PTSD	Other: EMDR-RTE Other: TAU	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMDR-RTE Eye movement desensitization and reprocessing in its recent traumatic episode version.	Other: EMDR-RTE The experimental group will have EMDR recent traumatic event.
Active Comparator: TAU Usual treatment by a psychologist.	Other: TAU The comparator group will have usual psychological intervention.

Arm

Intervention/Treatment

Experimental: EMDR-RTE

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

Other: EMDR-RTE

The experimental group will have EMDR recent traumatic event.

Active Comparator: TAU

Usual treatment by a psychologist.

Other: TAU

The comparator group will have usual psychological intervention.

Outcome Measures

Primary Outcome Measures

PCL-5 [Within the first month after perinatal loss]
PTSD Checklist for DSM-5
PCL-5 [3 months after perinatal loss]
PTSD Checklist for DSM-5

Secondary Outcome Measures

STAI S/T [Within the first month after perinatal loss]
Spielberger State/Trait Anxiety Inventory
STAI S/T [3 months after perinatal loss]
Spielberger State/Trait Anxiety Inventory
BDI-II [Within the first month after perinatal loss]
Beck Depression Inventory
BDI-II [3 months after perinatal loss]
Beck Depression Inventory

Other Outcome Measures

Satisfaction survey [3 months after perinatal loss]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Clinic of Barcelona
EMDR Europe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT05701137

Other Study ID Numbers:

2022-03

First Posted:

Jan 27, 2023

Last Update Posted:

Jan 27, 2023

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Clinic of Barcelona

perinatal loss

PTSD

EMDR

Study Results

No Results Posted as of Jan 27, 2023