Parental EMDR Therapy After a Baby's Stay in the NICU (EMDR-NICU)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Other: treatment as usual (TAU) (Control Group)

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulla Sankilampi, professor; Phone Number: +358447172464; Email: ulla.sankilampi@kuh.fi

Study Locations

• Finland
  • Kuopio, Finland, 70211
    • Kuopio University Hospital
    • Contact: Ulla Sankilampi, professor; Phone Number: +358447172464; Email: ulla.sankilampi@kuh.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMDR + TAU (Immediate EMDR); 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).	Behavioral: 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.; Other: 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.
Active Comparator: TAU + EMDR (Delayed EMDR); 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).	Behavioral: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks after randomization (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 weeks to 12 weeks (T2 to T3)
Durability of the EMDR treatment effect	Assessment of persistence of the initial EMDR treatment effect.	6 weeks to 12 weeks (T2 to T3)

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Infant, Newborn; Parents; Intensive Care Units, Neonatal; Eye Movement Desensitization and Reprocessing; Psychological Trauma; Post-Traumatic Stress Disorders; Psychotherapy, Trauma Focused
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Psychological Trauma; Stress Disorders, Post-Traumatic; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic; Control Groups; Therapeutics; Eye Movement Desensitization Reprocessing
• Other Study ID Numbers: 61/13.00/2025; 1615 (Other Identifier: Wellbeing Services County of North Savo, Finland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No