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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05600868
Other study ID # CUP
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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