The Effect of Dual Attention in an EMDR Intervention

NCT ID: NCT05600868

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-12-31

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).

Conditions

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Trauma, Psychological Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EMDR+dual attention

.Processing the trauma with exposition and dual attention.

Group Type ACTIVE_COMPARATOR

A comprehensive third-generation intervention EMDR + dual attention

Intervention Type 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 + fixed point

Processing the trauma with exposition and fixed point.

Group Type ACTIVE_COMPARATOR

A comprehensive third-generation intervention EMDR + fixed point

Intervention Type 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 + exposition

Processing the trauma with exposition.

Group Type ACTIVE_COMPARATOR

A comprehensive third-generation intervention EMDR + dual attention

Intervention Type 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.

A comprehensive third-generation intervention EMDR + exposition

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carmen Valiente

Pozuelo de Alarcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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CUP

Identifier Type: -

Identifier Source: org_study_id

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