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

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ClinicalTrials.gov Identifier: NCT04431765

Recruitment Status : Recruiting

First Posted : June 16, 2020

Last Update Posted : February 10, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Januel, Centre hospitalier de Ville-Evrard, France

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Post-traumatic Stress Disorder	Other: Eye Movement Desensitization Reprocessing therapy Behavioral: Trauma-Centred Cognitive and Behavioural Therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	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
Masking:	None (Open Label)
Primary Purpose:	Other
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.
Actual Study Start Date :	July 2, 2018
Estimated Primary Completion Date :	January 1, 2026
Estimated Study Completion Date :	February 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Post-Traumatic Stress Disorder

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Patient for Eye Movement desensitization Reprocessing therapy Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy	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. Other Name: EMDR
Placebo Comparator: patients for Trauma-Centred Cognitive and Behavioural Therapy Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy	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. Other Name: CBT

Arm

Intervention/treatment

Active Comparator: Patient for Eye Movement desensitization Reprocessing therapy

Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy

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.

Other Name: EMDR

Placebo Comparator: patients for Trauma-Centred Cognitive and Behavioural Therapy

Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy

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.

Other Name: CBT

Outcome Measures

Primary Outcome Measures :

Post Traumatic Stress Scale-5 (PCL-5) [ Time Frame: Before the therapy begins, at day 0 ]
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.
Post Traumatic Stress Scale-5 [ Time Frame: Within 3 weeks before the end of the therapy ]
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.
State Trait Anxiety Inventory (STAI) [ Time Frame: Before the therapy begins, at day 0 ]
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.
State Trait Anxiety Inventory (STAI) [ Time Frame: Within 3 weeks before the end of the therapy ]
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.
The Short Form (36) Health Survey (SF36) [ Time Frame: Before the therapy begins, at day 0 ]
TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).
The Short Form (36) Health Survey (SF36) [ Time Frame: Within 3 weeks before the end of the therapy ]
TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).
Childhood Trauma Questionnaire (CTQ) [ Time Frame: Before the therapy begins, at day 0 ]
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").
Childhood Trauma Questionnaire (CTQ) [ Time Frame: Within 3 weeks before the end of the therapy ]
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").
Clinician Administered PTSD Scale for DSM-5[CAPS-5]) [ Time Frame: Before the therapy begins, at day 0 ]
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
Clinician Administered PTSD Scale for DSM-5[CAPS-5]) [ Time Frame: Within 3 weeks before the end of the therapy ]
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
Clinical Global Impression (CGI) [ Time Frame: Before the therapy begins, at day 0 ]
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
Clinical Global Impression (CGI) [ Time Frame: Within 3 weeks before the end of the therapy ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431765

Contacts

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Contact: Rusheenthira THAVASEELAN, Msc	0143093232	r.thavaseelan@epsve.fr
Contact: Youcef BENCHERIF, MSC	0143093232	y.bencherif@epsve.fr

Locations

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France
Ch Ville Evrard	Recruiting
Neuilly-sur-Marne, France, 93330
Contact: Florence Durand, MSC f.durand@epsve.fr
Principal Investigator: Dominique Januel, MBBS

Sponsors and Collaborators

Centre hospitalier de Ville-Evrard, France

Investigators

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Principal Investigator:	Dominique Januel, MBBS	CHVille Evrard

More Information

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Responsible Party:	Januel, Head of the clinical research department (psychiatrist), Centre hospitalier de Ville-Evrard, France
ClinicalTrials.gov Identifier:	NCT04431765
Other Study ID Numbers:	10477M-ICE-EMDR
First Posted:	June 16, 2020 Key Record Dates
Last Update Posted:	February 10, 2023
Last Verified:	February 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Januel, Centre hospitalier de Ville-Evrard, France:


Eye Movement Information- Post-traumatic Stress Disorder

Additional relevant MeSH terms:

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Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders

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