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
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
Treatments tested in this trial
- Eye Movement Desensitization and Reprocessing (EMDR)
- treatment as usual (TAU) (Control Group)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kuopio University Hospital
Lead sponsor
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov