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

February 8, 2023 updated by: Januel, Centre hospitalier de Ville-Evrard, France

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Neuilly-sur-Marne, France, 93330
        • Recruiting
        • Ch Ville Evrard
        • Contact:
        • Principal Investigator:
          • Dominique Januel, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the therapy begins, at day 0
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.
Within 3 weeks before the end of the therapy
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.
Before the therapy begins, at day 0
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.
Within 3 weeks before the end of the therapy
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).
Before the therapy begins, at day 0
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).
Within 3 weeks before the end of the therapy
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").
Before the therapy begins, at day 0
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").
Within 3 weeks before the end of the therapy
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
Before the therapy begins, at day 0
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
Within 3 weeks before the end of the therapy
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
Before the therapy begins, at day 0
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
Within 3 weeks before the end of the therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de Ville-Evrard, France

Investigators

  • Principal Investigator: Dominique Januel, MBBS, CHVille Evrard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2018

Primary Completion (ANTICIPATED)

January 1, 2026

Study Completion (ANTICIPATED)

February 1, 2026

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (ACTUAL)

June 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10477M-ICE-EMDR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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