Theories of Working Memory and Consolidation/RECOnsolidation in the Process of Resorption of Post-traumatic Symptoms.
NCT Number: NCT06469333
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Working Memory|Consolidation/Recconsolidation Memory|Eye Movement Desensitization and Reprocessing|Alterning Bilateral Stimulation|Stress Disorders, Post-Traumatic|Intrusive Memories|Vividness|Emotivity
Interventions: BEHAVIORAL: Eye movements (EM)|BEHAVIORAL: Auditory stimulations|BEHAVIORAL: Tactile stimulations
Sponsor: University of Lorraine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2025-12
Locations: Umr U1319 Inspiire, Vandoeuvre-les-Nancy, 54505, France

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).

Primary Outcome Measures: 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 Outcome Measures: Assessment of the vividness of the intrusion, Vividness will be assessed via an analogous 11-point numerical scale ranging from 0 ("not vivid at all") to 10 ("extremely vivid"). This measure is frequently used in experimental research involving the application of a double task, 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, Psychological distress will be assessed using Kessler's Abbreviated Scale of Psychological Distress. This 6-item scale assesses the frequency of occurrence over the past month of anxiety-depressive emotional states and non-specific psychological distress. On a 5-point scale ranging from 0 "never" to 4 "all the time", the subject is asked to indicate how often he or she felt "nervous", "hopeless", "restless or out of place", "so depressed that nothing could make him or her smile", "that everything was an effort" and that he or she was "good for nothing". The total score obtained ranged from 0 to 24. According to the authors, a total score between 0 and 7 indicates low-intensity distress, a score of 8 to 12 indicates moderate distress, and a score of 13 or above indicates severe 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, Symptoms of intrusion will be measured using the Impact of Event Scale-Revised (IES-R). The IES-R is a 22-item scale measuring symptoms of intrusion (dreams about the event), avoidance/blunting (efforts to avoid reminders of the event) and hyperactivation (hypervigilance) in relation to a specific life-threatening event. The subject is asked to indicate on a 5-point Likert scale, from 0 "Not at all" to 4 "Extremely", how upset he or she may have been by difficulties relating to a specific stressful event over the past 7 days. The authors agree that a total score of 22 suggests the presence of acute stress, and a score of 36 indicates the presence of PTSD., 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, Insomnia will be measured by the Insomnia Severity Index (ISI) self-report questionnaire. This questionnaire consists of 7 items rated on a 5-point Likert scale. The total score, ranging from 0 to 28, is obtained by adding the scores of the 7 items. A high score of 28 or more indicates severe insomnia; a score of 15 to 21 indicates moderate insomnia; a score of 8 to 14 indicates sub-clinical insomnia. Finally, a score of 7 or less means no 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 Outcome Measures: Heart rate variability (HRV), Physiological measurement will be carried out by collecting Heart Rate Variability (HRV) using the CardiaSens system (http://www.i-virtual.fr/). RMSSD will be measured using the CardiaSens software integrated into the data collection system, before and after participants complete the questionnaires. Frequency and non-linear analyses of the VFC will also be carried out to complete the understanding of parasympathetic regulation in terms of flexibility and complexity., Before and during the experimental phase (7 days after Day 1)|Dissociative disorder, The presence of a dissociative disorder is assessed using the Dissociative Experiences Scale (DES). This self-administered questionnaire will be used to verify the non-inclusion criterion. Comprising 28 items, this scale measures the frequency of various dissociative symptoms in the respondent's daily life. Two factors are explored: episodes of automatic dissociation linked to the pilot (e.g., associated with different types of cognitive failure) and episodes of defensive dissociation that may act as defensive mechanisms, particularly in traumatized individuals (e.g., avoidance of a memory linked to a traumatic event). The total score is obtained by adding up the scores of the 28 items and dividing by 28, the resulting score ranging from 0 to 100. A high score, greater than or equal to 25, means that patients are more likely to have a dissociative disorder., At day 1 (D1)|Alcohol and drug consumption and the presence of psychotic disorders, The Mini International Neuropsychiatric Interview (M.I.N.I.) items assessing alcohol and drug use and the presence of psychotic disorders (pages 16 to 22) will be used to assess the absence of the participants' non-inclusion criteria, namely "drug or alcohol dependence" and "psychiatric history (psychosis type)". The M.I.N.I. has been designed as a brief, structured diagnostic interview for the major psychiatric disorders of the DSM-V., At day 1 (D1)