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Enrolling by Invitation

NCT Number: NCT05600868

The Effect of Dual Attention in an EMDR Intervention

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change from posttraumatic symptoms at 10 weeks and 6 months

    Time frame: Change baseline, 10 weeks, and 6 months

    International Trauma Questionnaire (ITQ; Cloitre et al., 2018). Higher scores mean a worse outcome.

  2. Change from psychopathological symptoms at 10 weeks and 6 months

    Time frame: Change baseline, 10 weeks, and 6 months

    Symptom Checklist 45-SCL-90R brief (Davison et al., 1997).Higher scores mean a worse outcome.

  3. Change from Dissociative symptoms at 10 weeks and 6 months

    Time frame: Change baseline, 10 weeks, and 6 months

    Dissociative Experience Scale DES II (Carlson and Putnam, 1993). Higher scores mean a worse outcome.

Secondary outcomes

  1. Change from Well-being at 10 weeks and 6 months

    Time frame: Change baseline, 10 weeks, and 6 months

    Scales of Psychological Well-Being (SPWB; Ryff & Keyes, 1995). Higher scores mean a better outcome.

  2. Change from Satisfaction with life at 10 weeks and 6 months

    Time frame: Change baseline, 10 weeks, and 6 months

    Satisfaction with Life Scale (SWLS; Diener et al., 1985).Higher scores mean a better outcome.

  3. Change from Emotion Regulation at 10 weeks and 6 months

    Time frame: Change baseline, 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

  4. Change from Attachment style at 10 weeks and 6 months

    Time frame: Change baseline, 10 weeks, and 6 months

    Psychosis Attachment Measure (PAM; Berry, 2006). Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: DA_EMDR

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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