The Effect of Dual Attention in an EMDR Intervention

Study Overview
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Brief Summary
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Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when higher-risk comorbidities (e.g., psychosis or substance use) are present. In particular, there are data pointing to the efficacy of prolonged exposure therapy and eye movement desensitization and reprocessing (EMDR) therapy. Clinical practice guidelines specifically recommend trauma-focused treatment with exposure and/or cognitive restructuring components. Regarding EMDR interventions, there are increasing results supporting its efficacy. Some interesting clinical advantages presented by EMDR as opposed to cognitive-behavioral therapies are 1) the efficacy found despite less exposure to the traumatic memory, 2) the exclusion of homework, 3) as well as the rapid reduction in subjective disturbance produced even after a single session of EMDR therapy. However, the mechanisms producing the improvement and, in particular, the effect of bilateral stimulation are not precisely known. More research is needed in this regard since bilateral stimulation is the most controversial part and with less evidence found. In addition to this, there are very few studies that have analyzed the differential efficacy of the presence or absence of bilateral stimulation or of the different types of stimulation possible. As for the comparison between types of stimulation (bilateral with eye movements, or focusing on a fixed point), greater treatment effects have been found for EMDR with fixation on an immobile hand compared to eye movements. The aim of this study is to examine the effectiveness of a comprehensive intervention protocol for people who have experienced traumatic events and present post-traumatic symptomatology. In addition, this study will compare the efficacy of traumatic memory processing with and without dual attention.

Detailed Description
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The protocol will be developed following the three stages of recovery from trauma: first, focusing on establishing the therapeutic alliance and safety; second, focusing on recounting and re-processing the traumatic event; and third, focusing on reconnecting with others and with life despite the trauma experienced. This study will analyze the differences of type of traumatic processing; 1. using bilateral stimulation, 2. using fixed-point focusing and 3. closing the eyes (only exposure to the traumatic memory, without dual attention).

Official Title
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The Effect of Dual Attention in an EMDR Intervention for Posttraumatic Symptomatology: a Randomized Clinical Trial

Conditions
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Trauma, Psychological, Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: A comprehensive third-generation intervention EMDR + dual attention
* Behavioral: A comprehensive third-generation intervention EMDR + fixed point
* Behavioral: A comprehensive third-generation intervention EMDR + exposition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those showing a high risk of PTSD (TSQ ≥6 or TSQ ≥4 with clinical criteria) will be further evaluated to determine whether they meet the inclusion criteria. Participants must: Be between the ages of 18 and 65 fluent enough in Spanish language; 2. Exclusion Criteria: Present severe active suicidal ideation, or have made a self-injurious attempt during the last month. Present a diagnosis of substance dependence, intellectual disability or severe cognitive dysfunction. Participants with a score greater than or equal to 26 on the BDI-II, the inclusion of the person in the study will be assessed by clinical criteria. Having received EMDR treatment in the last 6 months. Also excluded from the program are those people who cannot guarantee continuity in the therapeutic process.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMDR+dual attention<br>.Processing the trauma with exposition and dual attention. | Behavioral: A comprehensive third-generation intervention EMDR + dual attention<br>* This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with double attention.<br>|
| Active Comparator: EMDR + fixed point<br>Processing the trauma with exposition and fixed point. | Behavioral: A comprehensive third-generation intervention EMDR + fixed point<br>* This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with fixed point.<br>|
| Active Comparator: EMDR + exposition<br>Processing the trauma with exposition. | Behavioral: A comprehensive third-generation intervention EMDR + dual attention<br>* This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with double attention.<br>Behavioral: A comprehensive third-generation intervention EMDR + exposition<br>* This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with exposition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from posttraumatic symptoms at 10 weeks and 6 months | International Trauma Questionnaire (ITQ; Cloitre et al., 2018). Higher scores mean a worse outcome. | Change baseline, 10 weeks, and 6 months | 
| Change from psychopathological symptoms at 10 weeks and 6 months | Symptom Checklist 45-SCL-90R brief (Davison et al., 1997).Higher scores mean a worse outcome. | Change baseline, 10 weeks, and 6 months | 
| Change from Dissociative symptoms at 10 weeks and 6 months | Dissociative Experience Scale DES II (Carlson and Putnam, 1993). Higher scores mean a worse outcome. | Change baseline, 10 weeks, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Well-being at 10 weeks and 6 months | Scales of Psychological Well-Being (SPWB; Ryff & Keyes, 1995). Higher scores mean a better outcome. | Change baseline, 10 weeks, and 6 months | 
| Change from Satisfaction with life at 10 weeks and 6 months | Satisfaction with Life Scale (SWLS; Diener et al., 1985).Higher scores mean a better outcome. | Change baseline, 10 weeks, and 6 months | 
| Change from Emotion Regulation at 10 weeks and 6 months | Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski & Kraaij, 2007).Higher scores mean better outcome for functional dimensions and worse outcome for disfunctional dimensions | Change baseline, 10 weeks, and 6 months | 
| Change from Attachment style at 10 weeks and 6 months | Psychosis Attachment Measure (PAM; Berry, 2006). Higher scores mean a worse outcome. | Change baseline, 10 weeks, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Traumatic Stress Disorder, EMDR, Dual Attention