Pregnancy LossNCT05701137
Effectiveness of an EMDR Intervention for Perinatal Loss
A study testing EMDR-RTE and TAU in people with Pregnancy Loss and PTSD, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Loss, PTSD
- What is being tested?
- EMDR-RTE and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2023to 23 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years old
- agree to participate and sign the informed consent
- request psychological treatment
Who cannot join
- active substance use disorder
- cognitive disability
- language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Eye Movement Desensitization and Reprocessing (EMDR) Intervention for the Prevention of Post-traumatic Symptoms in 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.
Read the 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.
- Conditions
- Pregnancy Loss, PTSD
- Being tested
- EMDR-RTE, TAU
- Keywords
- perinatal loss, PTSD, EMDR
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR-RTEOther
The experimental group will have EMDR recent traumatic event.
TAUOther
The comparator group will have usual psychological intervention.
| Study group | Role | What they receive |
|---|---|---|
| EMDR-RTE | Experimental | Eye movement desensitization and reprocessing in its recent traumatic episode version. Receives: Other: EMDR-RTE |
| TAU | Active comparator | Usual treatment by a psychologist. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCL-5
PTSD Checklist for DSM-5
Measured: Within the first month after perinatal loss
PCL-5
PTSD Checklist for DSM-5
Measured: 3 months after perinatal loss
Secondary outcomes (4)
STAI S/T
Spielberger State/Trait Anxiety Inventory
Measured: Within the first month after perinatal loss
STAI S/T
Spielberger State/Trait Anxiety Inventory
Measured: 3 months after perinatal loss
BDI-II
Beck Depression Inventory
Measured: Within the first month after perinatal loss
BDI-II
Beck Depression Inventory
Measured: 3 months after perinatal loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start17 Apr 2023
- Primary completion30 Nov 2024
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- EMDR Europe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701137
- Sponsor's protocol ID
- 2022-03
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40551815
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Eye Movement Desensitization and Reprocessing (EMDR) Intervention for the Prevention of Post-traumatic Symptoms in Perinatal Loss
- ClinicalTrials.gov ID
- NCT05701137
- Acronym / sponsor ID
- 2022-03
- Conditions
- Pregnancy Loss, PTSD
- Keywords
- perinatal loss, PTSD, EMDR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- EMDR Europe
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMDR-RTE | Experimental | Other: EMDR-RTEEye movement desensitization and reprocessing in its recent traumatic episode version. |
| TAU | Active comparator | Other: TAUUsual treatment by a psychologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be over 18 years old
- agree to participate and sign the informed consent
- request psychological treatment
Key exclusion criteria (3 listed)
- active substance use disorder
- cognitive disability
- language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR-RTEThe experimental group will have EMDR recent traumatic event. | Other | EMDR-RTE |
| TAUThe comparator group will have usual psychological intervention. | Other | TAU |
Primary outcome
PCL-5
Time frame: Within the first month after perinatal loss
PTSD Checklist for DSM-5
PCL-5
Time frame: 3 months after perinatal loss
PTSD Checklist for DSM-5
4 secondary outcomes
STAI S/T
Time frame: Within the first month after perinatal loss
STAI S/T
Time frame: 3 months after perinatal loss
BDI-II
Time frame: Within the first month after perinatal loss
BDI-II
Time frame: 3 months after perinatal loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Results publication: PubMed 40551815Sureda-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR-RTE and TAU in people with Pregnancy Loss and PTSD, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCL-5 (time frame: Within the first month after perinatal loss). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.