NCT07471321: 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

Not yet recruiting NA Last updated 12 March 2026

What this trial tests

NA trial testing Eye Movement Desensitization and Reprocessing (EMDR) in Stress Disorders, Post-Traumatic in 80 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
1 April 2027

1 August 2027

Quick facts

Lead sponsor	Kuopio University Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 March 2026
Primary completion	1 April 2027
Estimated completion	1 August 2027
Sites	1 location across Finland

Drugs / interventions tested

• Eye Movement Desensitization and Reprocessing (EMDR)
• treatment as usual (TAU) (Control Group) — full drug profile →

Conditions studied

• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →

Sponsor

Kuopio University Hospital

Who can join

18 and older, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.