Trauma, PsychologicalDA_EMDRNCT05600868
The Effect of Dual Attention in an EMDR Intervention
A study testing A comprehensive third-generation intervention EMDR + dual attention, A comprehensive third-generation intervention EMDR + fixed point and A comprehensive third-generation intervention EMDR + exposition in people with Trauma, Psychological and Traumatic Stress Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma, Psychological, Traumatic Stress Disorder
- What is being tested?
- A comprehensive third-generation intervention EMDR + dual attention, A comprehensive third-generation intervention EMDR + fixed point and A comprehensive third-generation intervention EMDR + exposition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Dual Attention in an EMDR Intervention for Posttraumatic Symptomatology: a Randomized Clinical Trial
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.
Read the 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).
- Conditions
- Trauma, Psychological, Traumatic Stress Disorder
- Being tested
- A comprehensive third-generation intervention EMDR + dual attention, A comprehensive third-generation intervention EMDR + fixed point, A comprehensive third-generation intervention EMDR + exposition
- Keywords
- Trauma, Traumatic Stress Disorder, EMDR, Dual Attention
- Medical subject headings
- Psychological Trauma, Stress Disorders, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A comprehensive third-generation intervention EMDR + dual attentionBehavioural
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 pointBehavioural
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 + expositionBehavioural
This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with exposition.
| Study group | Role | What they receive |
|---|---|---|
| EMDR+dual attention | Active comparator | .Processing the trauma with exposition and dual attention. Receives: Behavioral: A comprehensive third-generation intervention EMDR + dual attention |
| EMDR + fixed point | Active comparator | Processing the trauma with exposition and fixed point. Receives: Behavioral: A comprehensive third-generation intervention EMDR + fixed point |
| EMDR + exposition | Active comparator | Processing the trauma with exposition. Receives: Behavioral: A comprehensive third-generation intervention EMDR + dual attention; Behavioral: A comprehensive third-generation intervention EMDR + exposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from posttraumatic symptoms at 10 weeks and 6 months
International Trauma Questionnaire (ITQ; Cloitre et al., 2018). Higher scores mean a worse outcome.
Measured: Change baseline, 10 weeks, and 6 months
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.
Measured: Change baseline, 10 weeks, and 6 months
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.
Measured: Change baseline, 10 weeks, and 6 months
Secondary outcomes (4)
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.
Measured: Change baseline, 10 weeks, and 6 months
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.
Measured: Change baseline, 10 weeks, and 6 months
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
Measured: Change baseline, 10 weeks, and 6 months
Change from Attachment style at 10 weeks and 6 months
Psychosis Attachment Measure (PAM; Berry, 2006). Higher scores mean a worse outcome.
Measured: Change baseline, 10 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Sep 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600868
- Sponsor's protocol ID
- CUP
- Acronym
- DA_EMDR
- Status last verified
- Apr 2025
- First submitted
- 26 Oct 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual Attention in an EMDR Intervention for Posttraumatic Symptomatology: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05600868
- Acronym / sponsor ID
- DA_EMDR / CUP
- Conditions
- Trauma, Psychological, Traumatic Stress Disorder
- Keywords
- Trauma, Traumatic Stress Disorder, EMDR, Dual Attention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMDR+dual attention | Active comparator | Behavioral: A comprehensive third-generation intervention EMDR + dual attention.Processing the trauma with exposition and dual attention. |
| EMDR + fixed point | Active comparator | Behavioral: A comprehensive third-generation intervention EMDR + fixed pointProcessing the trauma with exposition and fixed point. |
| EMDR + exposition | Active comparator | Behavioral: A comprehensive third-generation intervention EMDR + dual attention, Behavioral: A comprehensive third-generation intervention EMDR + expositionProcessing the trauma with exposition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A comprehensive third-generation intervention EMDR + dual attentionThis is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with double attention. | Behavioural | EMDR + exposition, EMDR+dual attention |
| A comprehensive third-generation intervention EMDR + fixed pointThis is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with fixed point. | Behavioural | EMDR + fixed point |
| A comprehensive third-generation intervention EMDR + expositionThis is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with exposition. | Behavioural | EMDR + exposition |
Primary outcome
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.
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.
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.
4 secondary outcomes
Change from Well-being at 10 weeks and 6 months
Time frame: Change baseline, 10 weeks, and 6 months
Change from Satisfaction with life at 10 weeks and 6 months
Time frame: Change baseline, 10 weeks, and 6 months
Change from Emotion Regulation at 10 weeks and 6 months
Time frame: Change baseline, 10 weeks, and 6 months
Change from Attachment style at 10 weeks and 6 months
Time frame: Change baseline, 10 weeks, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A comprehensive third-generation intervention EMDR + dual attention, A comprehensive third-generation intervention EMDR + fixed point and A comprehensive third-generation intervention EMDR + exposition in people with Trauma, Psychological and Traumatic Stress Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from posttraumatic symptoms at 10 weeks and 6 months (time frame: Change baseline, 10 weeks, and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.