Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]

Post-traumatic Stress Disorder Clinical Trial

— ICE-EMDR  

Official title:

Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]: Neuronal Correlates and Cognitive Impact on the Attention and Memory of Emotional Stimuli.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431765
• Other study ID #: 10477M-ICE-EMDR
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2023
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Rusheenthira THAVASEELAN, Msc
• Phone: 0143093232
• Email: r.thavaseelan[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: February 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient diagnosed with PTSD according to DSM 5 criteria (APA 2013) related to a single traumatic event,
• Aged 18 to 65 years,
• Signed informed consent.
• Patient with social security affiliation or State Medical Aid (AME)

Exclusion Criteria:

• Neurological disorders
• No other major psychiatric disorders than PTSD (DSM 5)
• Severe and/or unstable somatic pathologies,
• Patient not affiliated with social security,
• Patient hospitalized under stress in psychiatric care at the decision of the state representative or in psychiatric care at the request of a third party,
• Patient under guardianship,
• Patient participating in parallel with other biomedical research,
• Change of antidepressant during the last three months,
• Patient not fluent in French
• MR-specific criteria for not inclusion:
• women of childbearing age without effective contraception or a positive pregnancy test,
• patients carrying pacemakers or electrical or electronic devices, clips or metal prostheses,
• subjects with neurological disorders, cerebral abnormalities or suffering from claustrophobia.

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Eye Movement Desensitization Reprocessing therapy
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.

Behavioral:
• Trauma-Centred Cognitive and Behavioural Therapy
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.

Locations

Country	Name	City	State
France	Ch Ville Evrard	Neuilly-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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