DA_EMDR: The Effect of Dual Attention in an EMDR Intervention

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT05600868
Collaborator
(none)
100
1
3
35
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A comprehensive third-generation intervention EMDR + dual attention
  • Behavioral: A comprehensive third-generation intervention EMDR + fixed point
  • Behavioral: A comprehensive third-generation intervention EMDR + exposition
N/A

Detailed 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Dual Attention in an EMDR Intervention for Posttraumatic Symptomatology: a Randomized Clinical Trial
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: EMDR+dual attention

.Processing the trauma with exposition and dual attention.

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.

Active Comparator: EMDR + fixed point

Processing the trauma with exposition and fixed point.

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.

Active Comparator: EMDR + exposition

Processing the trauma with exposition.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. Change from Well-being at 10 weeks and 6 months [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 [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 [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 [Change baseline, 10 weeks, and 6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carmen Valiente Pozuelo de Alarcón Madrid Spain 28223

Sponsors and Collaborators

  • Universidad Complutense de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT05600868
Other Study ID Numbers:
  • CUP
First Posted:
Nov 1, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidad Complutense de Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2022