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

ConditionStress Disorders, Post-Traumatic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKuopio University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • treatment as usual (TAU) (Control Group)

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: EMDR + TAU (Immediate EMDR)Experimental treatment 2 interventions
Group B: TAU + EMDR (Delayed EMDR)Active comparator 2 interventions

Trial outcomes

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.

Time frame
6 weeks after randomization (T2)

Secondary outcomes

1

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.

Time frame
Baseline to 6 weeks (T1 to T2)
2

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.

Time frame
Baseline to 6 weeks (T1 to T2)
3

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.

Time frame
6 weeks to 12 weeks (T2 to T3)
4

Durability of the EMDR treatment effect

Assessment of persistence of the initial EMDR treatment effect.

Time frame
6 weeks to 12 weeks (T2 to T3)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kuopio University Hospital

Lead sponsor

University of Eastern Finland

Collaborator

Source ClinicalTrials.gov

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