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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• PTSD symptom severity measured with the PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: 6 weeks after randomization (T2)]

Вторичные конечные точки (4)

• Clinically meaningful improvement in PTSD symptoms (Responder analysis) [Срок оценки: Baseline to 6 weeks (T1 to T2)]
• Naturalistic symptom change during the initial TAU period [Срок оценки: Baseline to 6 weeks (T1 to T2)]
• Effect of delayed EMDR treatment [Срок оценки: 6 weeks to 12 weeks (T2 to T3)]
• Durability of the EMDR treatment effect [Срок оценки: 6 weeks to 12 weeks (T2 to T3)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Финляндия · 1 центр

• Kuopio University Hospital — Kuopio

Идентификаторы

NCT: NCT07471321 · 61/13.00/2025 · 1615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗