Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1615 | Other Identifier | Wellbeing Services County of North Savo, Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulla Sankilampi, Professor | Contact | +358447172464 | ulla.sankilampi@kuh.fi |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | 70211 | Finland |
Individual participant data will not be made publicly available
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| D013812 | Therapeutics |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Baseline to 6 weeks (T1 to T2) |
| 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. | Baseline to 6 weeks (T1 to T2) |
| 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. | 6 weeks to 12 weeks (T2 to T3) |
| Durability of the EMDR treatment effect | Assessment of persistence of the initial EMDR treatment effect. | 6 weeks to 12 weeks (T2 to T3) |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |