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Enrolling by invitation Not applicable

The Effect of Dual Attention in an EMDR Intervention

NCT05600868 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2022-09-01
Last updated
2025-04-25

Condition(s) studied

Trauma, PsychologicalTraumatic Stress Disorder

Investigational drug(s) / intervention(s)

A comprehensive third-generation intervention EMDR + dual attentionA comprehensive third-generation intervention EMDR + fixed pointA comprehensive third-generation intervention EMDR + exposition

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.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Carmen Valiente Pozuelo de Alarcón Madrid
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05600868 on ClinicalTrials.gov ↗ ← All trials in Spain