Stress Disorders, Post-TraumaticEMDR-NICUNCT07471321
Parental EMDR Therapy After a Baby's Stay in the NICU
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Stress Disorders, Post-Traumatic, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
This randomized clinical trial evaluates the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy in reducing symptoms of post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Presence of post-traumatic stress symptoms
- Eligible to receive EMDR therapy according to clinical assessment
- Ability to understand study procedures and provide informed consent
- Sufficient proficiency in the Finnish language to complete study assessments and participate in therapy
Who cannot join
- Acute psychiatric condition requiring immediate specialized treatment (e.g., acute psychosis or severe suicidal crisis).
- Severe cognitive impairment or neurological condition that would prevent participation in psychotherapy or completion of study assessments.
- Ongoing trauma-focused psychotherapy at the time of enrollment.
- Any condition judged by the investigator to interfere with safe participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Kuopio University Hospital
Kuopio, 70211
Ulla Sankilampi, professor, +358447172464, ulla.sankilampi@kuh.fi
About this study
Official title: Effectiveness of an EMDR Intervention in Reducing Trauma-Related Symptoms Among Parents Following Their Infant's Birth and Neonatal Intensive Care: A Randomized Controlled Trial
This randomized clinical trial evaluates the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy in reducing symptoms of post-traumatic stress disorder (PTSD). Participants with PTSD symptoms will be randomly assigned in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR). Randomization will be stratified by sex.
PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary outcome is PTSD symptom severity measured by the PCL-5 at T2, comparing participants receiving EMDR+TAU with those receiving TAU alone during the first treatment period.
Secondary outcomes include clinically meaningful improvement in PTSD symptoms, defined as a reduction of at least 10 points on the PCL-5, symptom change during the initial treatment-as-usual period, the effect of delayed EMDR, and the durability of the EMDR treatment effect over time.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a common and disabling condition that may develop following exposure to traumatic events. Eye movement desensitization and reprocessing (EMDR) is a trauma-focused psychotherapy with demonstrated efficacy in the treatment of PTSD, but further research is needed to evaluate treatment outcomes in clinical populations and to examine the temporal course of symptom change.
The present study is a randomized clinical trial designed to evaluate the effectiveness of EMDR therapy in reducing PTSD symptoms. Participants with PTSD symptoms will be recruited from clinical services and randomly assigned in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR). Randomization will be stratified by sex to ensure balanced allocation between groups.
During the first 6-week treatment period, participants in the EMDR+TAU group will receive EMDR therapy in addition to treatment as usual, whereas participants in the TAU+EMDR group will receive treatment as usual only. After the first follow-up assessment, participants in the TAU+EMDR group will receive EMDR therapy during the second treatment period.
PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary outcome is PTSD symptom severity measured with the PCL-5 at T2, comparing participants receiving EMDR plus treatment as usual with those receiving treatment as usual alone during the first treatment period.
Secondary outcomes include clinically meaningful improvement in PTSD symptoms, defined as a reduction of at least 10 points on the PCL-5, symptom change during the initial treatment-as-usual period in the delayed-EMDR group, symptom change following delayed EMDR treatment, and the durability of the EMDR treatment effect over time.
The primary analysis will compare PCL-5 scores between groups at T2 adjusting for baseline PCL-5 scores and sex. Additional analyses will examine symptom trajectories across T1, T2, and T3 using mixed-effects models and will evaluate the proportion of participants achieving clinically meaningful improvement.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR), treatment as usual (TAU) (Control Group)
- Keywords
- Post-Traumatic Stress Disorders, Psychological Trauma, Eye Movement Desensitization and Reprocessing, Parents, Infant, Newborn, Intensive Care Units, Neonatal, Psychotherapy, Trauma Focused
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR)Behavioural
Eye movement desensitization and reprocessing (EMDR) therapy delivered by trained therapist according to standard EMDR procedures for the treatment of post-traumatic stress disorder.
treatment as usual (TAU) (Control Group)Other
Treatment as usual refers to the standard care normally available to patients with PTSD in the participating clinical setting. This may include routine clinical follow-up and other supportive care provided according to usual practice.
| Study group | Role | What they receive |
|---|---|---|
| EMDR + TAU (Immediate EMDR) | Experimental | Participants receive eye movement desensitization and reprocessing (EMDR) therapy in addition to treatment as usual during the first treatment period. PTSD symptoms are assessed at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Other: treatment as usual (TAU) (Control Group) |
| TAU + EMDR (Delayed EMDR) | Active comparator | Participants receive treatment as usual during the first treatment period. After the first assessment (T2), participants receive EMDR therapy during the second treatment period. PTSD symptoms are assessed at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Other: treatment as usual (TAU) (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity measured with the PTSD Checklist for DSM-5 (PCL-5)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure developed by the U.S. Department of Veterans Affairs, National Center for PTSD (available at www.ptsd.va.gov). Each item is rated on a 0-4 scale from "Not at all" to "Extremely," producing a total score range of 0 to 80, where higher scores indicate more severe PTSD symptoms.
The primary outcome is the comparison of PCL-5 total score between participants receiving EMDR plus treatment as usual (EMDR+TAU) and those receiving treatment as usual (TAU) during the first treatment period, adjusting for baseline PCL-5 score measured at T1.
Measured: 6 weeks after randomization (T2)
Secondary outcomes (4)
Clinically meaningful improvement in PTSD symptoms (Responder analysis)
Proportion of participants achieving a reduction of 10 points or more on the PCL-5 total score.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure developed by the U.S. Department of Veterans Affairs, National Center for PTSD (available at www.ptsd.va.gov). Each item is rated on a 0-4 scale from "Not at all" to "Extremely," producing a total score range of 0 to 80, where higher scores indicate more severe PTSD symptoms.
Measured: Baseline to 6 weeks (T1 to T2)
Naturalistic symptom change during the initial TAU period
Change in PCL-5 total score during the initial treatment-as-usual period in the delayed-EMDR group.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure developed by the U.S. Department of Veterans Affairs, National Center for PTSD ( available at www.ptsd.va.gov). Each item is rated on a 0-4 scale from "Not at all" to "Extremely," producing a total score range of 0 to 80, where higher scores indicate more severe PTSD symptoms.
Measured: Baseline to 6 weeks (T1 to T2)
Effect of delayed EMDR treatment
Change in PTSD symptom severity in participants receiving EMDR after the initial TAU period measured with the PCL-5 tool.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure developed by the U.S. Department of Veterans Affairs, National Center for PTSD (Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP; 2013; available at www.ptsd.va.gov). Each item is rated on a 0-4 scale from "Not at all" to "Extremely," producing a total score range of 0 to 80, where higher scores indicate more severe PTSD symptoms.
Measured: 6 weeks to 12 weeks (T2 to T3)
Durability of the EMDR treatment effect
Assessment of persistence of the initial EMDR treatment effect.
Measured: 6 weeks to 12 weeks (T2 to T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR) using stratified randomization by sex. During the first treatment period, participants receive either EMDR+TAU or TAU alone. After the first assessment (T2), participants in the TAU+EMDR group receive EMDR. PTSD symptoms are assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary comparison evaluates the effect of EMDR during the first treatment period.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Principal investigator, Ulla Sankilampi, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471321
- Sponsor's protocol ID
- 61/13.00/2025
- Other IDs
- 1615
- Acronym
- EMDR-NICU
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an EMDR Intervention in Reducing Trauma-Related Symptoms Among Parents Following Their Infant's Birth and Neonatal Intensive Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07471321
- Acronym / sponsor ID
- EMDR-NICU / 61/13.00/2025
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Disorders, Psychological Trauma, Eye Movement Desensitization and Reprocessing, Parents, Infant, Newborn, Intensive Care Units, Neonatal, Psychotherapy, Trauma Focused
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Mar 2026 (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.
This randomized clinical trial evaluates the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy in reducing symptoms of post-traumatic stress disorder (PTSD). Participants with PTSD symptoms will be randomly assigned in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR). Randomization will be stratified by sex.
PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary outcome is PTSD symptom severity measured by the PCL-5 at T2, comparing participants receiving EMDR+TAU with those receiving TAU alone during the first treatment period.
Secondary outcomes include clinically meaningful improvement in PTSD symptoms, defined as a reduction of at least 10 points on the PCL-5, symptom change during the initial treatment-as-usual period, the effect of delayed EMDR, and the durability of the EMDR treatment effect over time.
Detailed description
Post-traumatic stress disorder (PTSD) is a common and disabling condition that may develop following exposure to traumatic events. Eye movement desensitization and reprocessing (EMDR) is a trauma-focused psychotherapy with demonstrated efficacy in the treatment of PTSD, but further research is needed to evaluate treatment outcomes in clinical populations and to examine the temporal course of symptom change.
The present study is a randomized clinical trial designed to evaluate the effectiveness of EMDR therapy in reducing PTSD symptoms. Participants with PTSD symptoms will be recruited from clinical services and randomly assigned in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR). Randomization will be stratified by sex to ensure balanced allocation between groups.
During the first 6-week treatment period, participants in the EMDR+TAU group will receive EMDR therapy in addition to treatment as usual, whereas participants in the TAU+EMDR group will receive treatment as usual only. After the first follow-up assessment, participants in the TAU+EMDR group will receive EMDR therapy during the second treatment period.
PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary outcome is PTSD symptom severity measured with the PCL-5 at T2, comparing participants receiving EMDR plus treatment as usual with those receiving treatment as usual alone during the first treatment period.
Secondary outcomes include clinically meaningful improvement in PTSD symptoms, defined as a reduction of at least 10 points on the PCL-5, symptom change during the initial treatment-as-usual period in the delayed-EMDR group, symptom change following delayed EMDR treatment, and the durability of the EMDR treatment effect over time.
The primary analysis will compare PCL-5 scores between groups at T2 adjusting for baseline PCL-5 scores and sex. Additional analyses will examine symptom trajectories across T1, T2, and T3 using mixed-effects models and will evaluate the proportion of participants achieving clinically meaningful improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR) using stratified randomization by sex. During the first treatment period, participants receive either EMDR+TAU or TAU alone. After the first assessment (T2), participants in the TAU+EMDR group receive EMDR. PTSD symptoms are assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary comparison evaluates the effect of EMDR during the first treatment period.
| Arm | Type | Receives |
|---|---|---|
| EMDR + TAU (Immediate EMDR) | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR), Other: treatment as usual (TAU) (Control Group)Participants receive eye movement desensitization and reprocessing (EMDR) therapy in addition to treatment as usual during the first treatment period. PTSD symptoms are assessed at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). |
| TAU + EMDR (Delayed EMDR) | Active comparator | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR), Other: treatment as usual (TAU) (Control Group)Participants receive treatment as usual during the first treatment period. After the first assessment (T2), participants receive EMDR therapy during the second treatment period. PTSD symptoms are assessed at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Presence of post-traumatic stress symptoms
- Eligible to receive EMDR therapy according to clinical assessment
- Ability to understand study procedures and provide informed consent
- Sufficient proficiency in the Finnish language to complete study assessments and participate in therapy
Key exclusion criteria (4 listed)
- Acute psychiatric condition requiring immediate specialized treatment (e.g., acute psychosis or severe suicidal crisis).
- Severe cognitive impairment or neurological condition that would prevent participation in psychotherapy or completion of study assessments.
- Ongoing trauma-focused psychotherapy at the time of enrollment.
- Any condition judged by the investigator to interfere with safe participation in the study.
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 |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR)Eye movement desensitization and reprocessing (EMDR) therapy delivered by trained therapist according to standard EMDR procedures for the treatment of post-traumatic stress disorder. | Behavioural | EMDR + TAU (Immediate EMDR), TAU + EMDR (Delayed EMDR) |
| treatment as usual (TAU) (Control Group)Treatment as usual refers to the standard care normally available to patients with PTSD in the participating clinical setting. This may include routine clinical follow-up and other supportive care provided according to usual practice. | Other | EMDR + TAU (Immediate EMDR), TAU + EMDR (Delayed EMDR) |
Primary outcome
PTSD symptom severity measured with the PTSD Checklist for DSM-5 (PCL-5)
Time frame: 6 weeks after randomization (T2)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure developed by the U.S. Department of Veterans Affairs, National Center for PTSD (available at www.ptsd.va.gov). Each item is rated on a 0-4 scale from "Not at all" to "Extremely," producing a total score range of 0 to 80, where higher scores indicate more severe PTSD symptoms. The primary outcome is the comparison of PCL-5 total score between participants receiving EMDR plus treatment as usual (EMDR+TAU) and those receiving treatment as usual (TAU) during the first treatment period, adjusting for baseline PCL-5 score measured at T1.
4 secondary outcomes
Clinically meaningful improvement in PTSD symptoms (Responder analysis)
Time frame: Baseline to 6 weeks (T1 to T2)
Naturalistic symptom change during the initial TAU period
Time frame: Baseline to 6 weeks (T1 to T2)
Effect of delayed EMDR treatment
Time frame: 6 weeks to 12 weeks (T2 to T3)
Durability of the EMDR treatment effect
Time frame: 6 weeks to 12 weeks (T2 to T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Stress Disorders, Post-Traumatic, run by Kuopio University Hospital at 1 site in Finland.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Mar 2026. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulla Sankilampi, Professor (+358447172464, ulla.sankilampi@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity measured with the PTSD Checklist for DSM-5 (PCL-5) (time frame: 6 weeks after randomization (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.