The Effect of Dual Attention in an EMDR Intervention

NCT05600868 | Enrolling By Invitation

• 1 other identifier: CUP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma, Psychological; Traumatic Stress Disorder

Keywords

Trauma; Traumatic Stress Disorder; EMDR; Dual Attention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change from Well-being at 10 weeks and 6 months

  Change baseline, 10 weeks, and 6 months

• Change from Satisfaction with life at 10 weeks and 6 months

  Change baseline, 10 weeks, and 6 months

• Change from Emotion Regulation at 10 weeks and 6 months

  Change baseline, 10 weeks, and 6 months

• Change from Attachment style at 10 weeks and 6 months

  Change baseline, 10 weeks, and 6 months

Study Arms (3)

EMDR+dual attention

ACTIVE COMPARATOR

.Processing the trauma with exposition and dual attention.

Behavioral: A comprehensive third-generation intervention EMDR + dual attention

EMDR + fixed point

ACTIVE COMPARATOR

Processing the trauma with exposition and fixed point.

Behavioral: A comprehensive third-generation intervention EMDR + fixed point

EMDR + exposition

ACTIVE COMPARATOR

Processing the trauma with exposition.

Behavioral: A comprehensive third-generation intervention EMDR + dual attention; Behavioral: A comprehensive third-generation intervention EMDR + exposition

Interventions

A comprehensive third-generation intervention EMDR + dual attention BEHAVIORAL

This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with double attention.

EMDR + exposition; EMDR+dual attention

A comprehensive third-generation intervention EMDR + fixed point BEHAVIORAL

This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with fixed point.

EMDR + fixed point

A comprehensive third-generation intervention EMDR + exposition BEHAVIORAL

This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with exposition.

EMDR + exposition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18 and 65 fluent enough in Spanish language; 2.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Psychological Trauma; Stress Disorders, Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 1, 2022
• Study Start: September 1, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)