Effectiveness of an EMDR Intervention for Perinatal Loss

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Loss, PTSD

Intervention / Treatment
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* Other: EMDR-RTE
* Other: TAU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI S/T | Spielberger State/Trait Anxiety Inventory | Within the first month after perinatal loss | 
| STAI S/T | Spielberger State/Trait Anxiety Inventory | 3 months after perinatal loss | 
| BDI-II | Beck Depression Inventory | Within the first month after perinatal loss | 
| BDI-II | Beck Depression Inventory | 3 months after perinatal loss | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perinatal loss, PTSD, EMDR