Stress Disorders, Post-Traumatic
Conditions
Keywords
Post-Traumatic Stress Disorders, Psychological Trauma, Eye Movement Desensitization and Reprocessing, Parents, Infant, Newborn, Intensive Care Units, Neonatal, Psychotherapy, Trauma Focused
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.
Detailed description
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.
Interventions
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 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.
Sponsors
Kuopio University Hospital
University of Eastern Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD symptom severity measured with the PTSD Checklist for DSM-5 (PCL-5) | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically meaningful improvement in PTSD symptoms (Responder analysis) | Baseline to 6 weeks (T1 to T2) | 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. |
| Naturalistic symptom change during the initial TAU period | Baseline to 6 weeks (T1 to T2) | 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. |
| Effect of delayed EMDR treatment | 6 weeks to 12 weeks (T2 to T3) | 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. |
| Durability of the EMDR treatment effect | 6 weeks to 12 weeks (T2 to T3) | Assessment of persistence of the initial EMDR treatment effect. |
Countries
Finland
Contacts
CONTACTUlla Sankilampi, Professor
Outcome results
None listed