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

NCT07471321 | Not Yet Recruiting

• 2 other identifiers: 61/13.00/20251615
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinically meaningful improvement in PTSD symptoms (Responder analysis)

  Baseline to 6 weeks (T1 to T2)

• Naturalistic symptom change during the initial TAU period

  Baseline to 6 weeks (T1 to T2)

• Effect of delayed EMDR treatment

  6 weeks to 12 weeks (T2 to T3)

• Durability of the EMDR treatment effect

  6 weeks to 12 weeks (T2 to T3)

Study Arms (2)

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).

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).

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Other: treatment as usual (TAU) (Control Group)

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) BEHAVIORAL

Eye movement desensitization and reprocessing (EMDR) therapy delivered by trained therapist according to standard EMDR procedures for the treatment of post-traumatic stress disorder.

EMDR + TAU (Immediate EMDR); TAU + EMDR (Delayed EMDR)

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.

EMDR + TAU (Immediate EMDR); TAU + EMDR (Delayed EMDR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics; Control Groups

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Ulla Sankilampi, Professor

CONTACT

+358447172464; ulla.sankilampi@kuh.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Neonatal Intensive Care Unit

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)