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

NCT06469333 | Recruiting DMC

• 1 other identifier: 2024-A00296-41
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Measurement of emotionality associated with an intrusive thought

  Emotionality will be assessed using the Subjective Units of Disturbance Scale (SUDS), which ranges from 0 ("no distress at all") to 10 ("maximum distress") and provides a subjective assessment of the disturbance associated with the intrusive thought.

  Before and after the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)

Secondary Outcomes (4)

• Assessment of the vividness of the intrusion

  Before and after the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)

• Psychological distress

  At day 1 (D1), before the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)

• Intrusion symptoms

  At day 1 (D1), the first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ) , through study completion (21 days after D1).

• Nature, impact and severity of insomnia

  the first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes )

Other Outcomes (3)

• Heart rate variability (HRV)

  Before and during the experimental phase (7 days after Day 1)

• Dissociative disorder

  At day 1 (D1)

• Alcohol and drug consumption and the presence of psychotic disorders

  At day 1 (D1)

Study Arms (4)

Control Group

NO INTERVENTION

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.

Eye movements (EM)

EXPERIMENTAL

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.

Behavioral: Eye movements (EM)

Eye movements and auditory stimulations (EM+AS)

EXPERIMENTAL

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).

Behavioral: Eye movements (EM); Behavioral: Auditory stimulations

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

EXPERIMENTAL

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).

Behavioral: Eye movements (EM); Behavioral: Auditory stimulations; Behavioral: Tactile stimulations

Interventions

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

Auditory stimulations BEHAVIORAL

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

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

Tactile stimulations BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lorraine: lead

Study Sites (1)

Umr U1319 Inspiire

Vandœuvre-lès-Nancy, 54505, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movements

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Central Study Contacts

Christine Rotonda

CONTACT

+33 03 72 74 82 26; christine.rotonda@univ-lorraine.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Methodologist/Epidemiologist Head of Research Unit, Pierre Jane Centre

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 21, 2024
• Study Start: September 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)