The Effect of Dual Attention in an EMDR Intervention

Trauma, Psychological Clinical Trial

— DA_EMDR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05600868
• Other study ID #: CUP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Trauma
• Stress Disorders, Traumatic
• Trauma, Psychological
• Traumatic Stress Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Carmen Valiente	Pozuelo de Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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