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This research aims to confirm that the therapeutic effect of EMDR is associated with changes in the interaction between cognitive function and emotional stimuli in PTSD patients compared to a controlled therapy in a randomized, single-blind study.On the other hand, this study aims to observe neuronal and cognitive correlates related to EMDR therapy compared to a control therapy.
This investigation would improve the understanding of the mechanisms of action of the EMDR, still unknown to date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient for Eye Movement desensitization Reprocessing therapy | Active Comparator | Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy |
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| patients for Trauma-Centred Cognitive and Behavioural Therapy | Placebo Comparator | Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Movement Desensitization Reprocessing therapy | Other | The Eye Movement Desensitization Reprocessing therapy uses bi-alternating (right-left) sensory stimulation through eye movements. The patient follows the therapist's fingers from right to left in front of his eyes and also by auditory stimuli. The patient wears a helmet that alternately makes him hear a sound to the right, then to the left or touch the patient holds in his hands buzzers that alternately vibrate from right to left, or alternatively the therapist taps the patient's knees or the back of his hands. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Traumatic Stress Scale-5 (PCL-5) | The PCL-5 is a self-assessment consisting of 20 items that measures the 20 PTSD symptoms of the DSM-5. The wording of the PCL-5 items reflects both changes in existing symptoms and the addition of new symptoms in the DSM-5. The objectives of PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with PTSD, making an interim diagnosis of PTSD. | Before the therapy begins, at day 0 |
| Post Traumatic Stress Scale-5 | The PCL-5 is a self-assessment consisting of 20 items that measures the 20 PTSD symptoms of the DSM-5. The wording of the PCL-5 items reflects both changes in existing symptoms and the addition of new symptoms in the DSM-5. The objectives of PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with PTSD, making an interim diagnosis of PTSD. | Within 3 weeks before the end of the therapy |
| State Trait Anxiety Inventory (STAI) | The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. | Before the therapy begins, at day 0 |
| State Trait Anxiety Inventory (STAI) | The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. | Within 3 weeks before the end of the therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rusheenthira THAVASEELAN, Msc | Contact | 0143093232 | r.thavaseelan@epsve.fr | |
| Youcef BENCHERIF, MSC | Contact | 0143093232 | y.bencherif@epsve.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dominique Januel, MBBS | CHVille Evrard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Ville Evrard | Recruiting | Neuilly-sur-Marne | 93330 | France |
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In one hand, Patients with Post-traumatic Stress Disorder who will receive Eye Movement desensitization reprocessing therapy and in other hand patient with post-traumatic Stress Disorder who will receive Trauma-Centred Cognitive and Behavioural Therapy
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| Trauma-Centred Cognitive and Behavioural Therapy | Behavioral | A CBT is a short, scientifically validated therapy that focuses on the interactions between thoughts, emotions and behaviours. These therapies focus on the current problems of the person, while taking into account their historical causes. They help gradually overcome disabling symptoms and aim to strengthen adaptive behaviours. A CBT relies on different techniques that help the patient to identify the mechanisms at the origin of his difficulties, to experiment with new behaviors and thus to gradually come out of vicious circles that perpetuate and aggravate the psychic suffering. |
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| The Short Form (36) Health Survey (SF36) |
TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate). |
| Before the therapy begins, at day 0 |
| The Short Form (36) Health Survey (SF36) | TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate). | Within 3 weeks before the end of the therapy |
| Childhood Trauma Questionnaire (CTQ) | The Childhood Trauma Questionnaire (CTQ) is a questionnaire developed by Bernstein et al. (1994) that includes 70 items with a Likert scale in five response choices (from 1 = "never true" to 5 = "very often true"). | Before the therapy begins, at day 0 |
| Childhood Trauma Questionnaire (CTQ) | The Childhood Trauma Questionnaire (CTQ) is a questionnaire developed by Bernstein et al. (1994) that includes 70 items with a Likert scale in five response choices (from 1 = "never true" to 5 = "very often true"). | Within 3 weeks before the end of the therapy |
| Clinician Administered PTSD Scale for DSM-5[CAPS-5]) | he CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD,Make lifetime diagnosis of PTSD, Assess PTSD symptoms over the past week | Before the therapy begins, at day 0 |
| Clinician Administered PTSD Scale for DSM-5[CAPS-5]) | he CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD,Make lifetime diagnosis of PTSD, Assess PTSD symptoms over the past week | Within 3 weeks before the end of the therapy |
| Clinical Global Impression (CGI) | The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders | Before the therapy begins, at day 0 |
| Clinical Global Impression (CGI) | The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders | Within 3 weeks before the end of the therapy |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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