The Effect of Dual Attention in an EMDR Intervention (DA_EMDR)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Trauma, Psychological; Traumatic Stress Disorder
• Intervention / Treatment: 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

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Valiente; Phone Number: +34913943135; Email: mcvalien@ucm.es
• Study Contact Backup: Name: Elena Cerezo; Email: ecerez01@ucm.es

Study Locations

• Spain
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Carmen Valiente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Trauma; EMDR; Traumatic Stress Disorder; Dual Attention
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Psychological Trauma
• Other Study ID Numbers: CUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No