Theories of Working Memory and Consolidation/RECOnsolidation in the Process of Resorption of Post-traumatic Symptoms.

NCT ID: NCT06469333

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

EMDR is a psychotherapeutic approach recommended by the World Health Organization (WHO) for the treatment of disorders such as post-traumatic stress disorder, anxiety, depression and, more generally, psychological distress. In all these disorders, intrusions are one of the symptoms leading to intense emotional distress. EMDR therapy, by making intrusions less emotional and less present in the mind (i.e. less vivid), would reduce psychological distress. This symptomatological reduction would be made possible by the therapist's application of alternating bilateral visual (rapid eye movements following a point from left to right), auditory (tones emitted alternately in the right ear and then in the left ear) and/or tactile (tapping with fingers on the left and right shoulders alternately) stimulations administered while the patient concentrates on his or her intrusive thoughts. Accordingly, the aim of this research is to investigate the efficacy of self-administration of Alternating Bilateral Stimulations (ABS), on the emotional intensity (emotionality) associated with negative intrusive thoughts (or intrusions).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intrusive thoughts (or intrusions) are recognized as being particularly vivid and emotionally "charged", and constitute one of the transdiagnostic symptoms of numerous disorders such as Post Traumatic Stress Disorder (PTSD), anxiety and depression.

Numerous studies have demonstrated that it is now possible to modulate the persistence of intrusions in memory, as well as their emotional impact, through Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR is based on the administration of visual, auditory (sound) or sensory (tapping) Alternating Bilateral Stimulations (ABS). These ABS, which can be self-administered by the patient during the Memory Activation (MA) of an intrusive thought, would reduce the emotionality and vividness of the intrusive symptoms and decrease the associated physiological reactivity.

Recent research claims that the mechanisms of action of ABS involve a joint articulation of both neurobiological (Memory Consolidation/Reconsolidation (M-C/R) and psychological (Working Memory (WM)) theories.

Memory consolidation refers to the transfer of a newly acquired memory trace into WM (fragile and susceptible to forgetting) and its stabilization in Long-Term Memory (LTM). Consolidation involves two processes. The first, synaptic consolidation, requires the triggering of molecular processes operating within a time window of between 10 minutes and 6 hours. The second, called systemic consolidation, can extend over years and takes place mainly during the sleep cycle. Reconsolidation implies that an intrusion, when activated in WM, becomes labile again and must subsequently be consolidated again (reconsolidated) in LTM. A permanent memory can thus be revived, then degraded, notably by the administration of ABS likely to interfere with its reconsolidation in memory.

Working memory (WM) refers to a memory system that enables the temporary retention and processing of information needed to perform complex cognitive tasks. capacity is limited. In fact, the competition of two simultaneous tasks (e.g. BAS administration during the memory activation (MA) of an intrusive thought) implies, in a consequential way, an alteration in its storage performance, as well as a decrease in the emotional load associated with the intrusion. In other words, while WM remains the strongest lead to date, it can only be considered in conjunction with M-C/R theory.

From a clinical/experimental protocol point of view, this link implies compliance with a number of criteria. The first is the temporal criterion for ABS administration (between 10 minutes and 6 hours post-MA), as well as the quantitative criterion relating to the number of MAs (not to exceed 4 MAs). In other words, the application of an interventional methodology that does not meet all these criteria (i.e., administration of ABS performed outside the M-C/R time window and repeated MA of the same intrusion) would induce the involvement of a third process, namely the extinction process. In one study, the application of an extinction protocol performed within the consolidation window (a paradigm known as Retrieval Extinction (P-R/E)) also induced a modification of the initial memory trace. It would therefore seem appropriate to consider the adoption of a tri-processual integrative model involving the joint articulation of Working Memory (WM), Memory Consolidation/Reconsolidation (C/R-M) and the Retrieval Extinction Paradigm (P-R/E). This is why we propose to study, in this research , the role of the application of this tri-processual theoretical modeling on the emotionality and vividness associated with intrusions, as well as on their psychophysiological and psychopathological consequences. Through the use of new technologies, these methodologies could complement conventional psychotherapeutic treatments which, through the self-administration of ABS, could add up and, in fact, potentiate the effectiveness of psychotherapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Working Memory Consolidation/Recconsolidation Memory Eye Movement Desensitization and Reprocessing Alterning Bilateral Stimulation Stress Disorders, Post-Traumatic Intrusive Memories Vividness Emotivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

The participant is asked to concentrate on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds, and to stare at the black computer screen.

Group Type NO_INTERVENTION

No interventions assigned to this group

Eye movements (EM)

The participant is asked to focus on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds and visually follow the horizontal displacement of a white dot (Ø 1cm) on the black screen at a constant speed of 1.2 Hz. This speed, implying the displacement of 1.2 left-right-left cycles per second, targets the saturation of working memory.

Group Type EXPERIMENTAL

Eye movements (EM)

Intervention Type BEHAVIORAL

The participant focuses on the intrusive thought and visually follows the horizontal movement of a white dot (Ø 1 cm) on the black computer screen 8 times for 24 seconds.

Eye movements and auditory stimulations (EM+AS)

The participant will have to concentrate on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds and follow the horizontal displacement of a white dot on the computer screen, while simultaneously perceiving the auditory "beep" tones in the headphones provided. These tones will be at a rate of 1.2 Hz (i.e. 1.2 left ear-right ear-left ear alternations per second).

Group Type EXPERIMENTAL

Eye movements (EM)

Intervention Type BEHAVIORAL

The participant focuses on the intrusive thought and visually follows the horizontal movement of a white dot (Ø 1 cm) on the black computer screen 8 times for 24 seconds.

Auditory stimulations

Intervention Type BEHAVIORAL

The participant focuses on the intrusive thoughts and hears the auditory "beeps" through the headphones provided 8 times for 24 seconds.

Eye movements, auditory stimulations and tactile stimulations (EM+AS+TS)

The participant is asked to concentrate on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds, and to follow the horizontal displacement of a white dot on the computer screen and simultaneously perceive the "beeps", as well as the tactile self-stimulations applied at a constant speed of 1.2Hz (i.e. 1.2 left-right-left tapping cycles per second).

Group Type EXPERIMENTAL

Eye movements (EM)

Intervention Type BEHAVIORAL

The participant focuses on the intrusive thought and visually follows the horizontal movement of a white dot (Ø 1 cm) on the black computer screen 8 times for 24 seconds.

Auditory stimulations

Intervention Type BEHAVIORAL

The participant focuses on the intrusive thoughts and hears the auditory "beeps" through the headphones provided 8 times for 24 seconds.

Tactile stimulations

Intervention Type BEHAVIORAL

The participant focuses on the intrusive thought and applies tactile self-stimulation 8 times for 24 seconds.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eye movements (EM)

The participant focuses on the intrusive thought and visually follows the horizontal movement of a white dot (Ø 1 cm) on the black computer screen 8 times for 24 seconds.

Intervention Type BEHAVIORAL

Auditory stimulations

The participant focuses on the intrusive thoughts and hears the auditory "beeps" through the headphones provided 8 times for 24 seconds.

Intervention Type BEHAVIORAL

Tactile stimulations

The participant focuses on the intrusive thought and applies tactile self-stimulation 8 times for 24 seconds.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Present symptoms of acute stress (score between 22 and 35 on the Impact Event Scale-Revised, IES-R) and/or PTSD (higher score or equal to 36 on the IES-R), but at least present moderate to high psychological distress (score equal to or greater than 8 on the Kessler Abbreviated Psychological Distress Scale, K6);
* Being in need of psychotherapeutic follow-up but not having started it yet;
* Be aged between 18 and 65 years inclusive;
* Speak and write French (be able to understand information and complete questionnaires independently);
* Have good vision (being able to follow the movement of a white point on a screen);
* Have good hearing and tactile abilities (being able to perceive auditory and tactile tones);
* Have a computer equipped with a webcam;
* Be informed and sign informed consent.

Exclusion Criteria

* Be an adult protected under guardianship or curatorship;
* Be a person subject to a judicial safeguard measure;
* Present a lack of autonomy implying an impossibility in terms of administering questionnaires and filling out questionnaires;
* Have a vision defect implying an impossibility of visual tracking of a white dot;
* Present a hearing defect and/or tactile abilities implying an impossibility of perception;
* Have a neurological condition constituting measurement biases (muscular dysfunctions, perceptual dysfunctions, etc.);
* Suffer from psychotraumatic and dissociative disorders of complex type (respectively evaluated with regard to the anamestistic data of the patients and with a score greater than 25 on the dissociative experiences scale (Dissociative Experiences Scale, DES);
* Do not present psychological distress (score less than 8 on the Kessler Abbreviated Psychological Distress Scale, K6) ;
* Have a drug or alcohol dependence;
* Benefit from ongoing psychotherapeutic monitoring;
* Have already benefited from psychotherapeutic follow-up or have participated in studies in the last 6 months, both involving EMDR therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lorraine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christine Rotonda

Methodologist/Epidemiologist Head of Research Unit, Pierre Jane Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Umr U1319 Inspiire

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christine Rotonda

Role: CONTACT

+33 03 72 74 82 26

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cyril Tarquinio, Pr

Role: primary

03 72 74 82 64

Christine Rotonda, PhD

Role: backup

03 72 74 82 26

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-A00296-41

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3MDR to Treat PTSD With mTBI (3MDR)
NCT03796936 COMPLETED PHASE2
The Effect of Dual Attention in an EMDR Intervention
NCT05600868 ENROLLING_BY_INVITATION NA
Reconsolidation and EMDR
NCT02572830 COMPLETED NA
Efficacy of an EMDR App for PTSD and SUD
NCT07146633 NOT_YET_RECRUITING NA