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

NCT04431765 | Unknown

• 1 other identifier: 10477M-ICE-EMDR
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Eye Movement Information- Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (12)

• 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

• 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

Study Arms (2)

Patient for Eye Movement desensitization Reprocessing therapy

ACTIVE COMPARATOR

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

Other: Eye Movement Desensitization Reprocessing therapy

patients for Trauma-Centred Cognitive and Behavioural Therapy

PLACEBO COMPARATOR

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

Behavioral: Trauma-Centred Cognitive and Behavioural Therapy

Interventions

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.

Also known as: EMDR

Patient for Eye Movement desensitization Reprocessing therapy

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.

Also known as: CBT

patients for Trauma-Centred Cognitive and Behavioural Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

Ch Ville Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing; Behavior Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dominique Januel, MBBS

  CHVille Evrard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rusheenthira THAVASEELAN, Msc

CONTACT

0143093232; r.thavaseelan@epsve.fr

Youcef BENCHERIF, MSC

CONTACT

0143093232; y.bencherif@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the clinical research department (psychiatrist)

Model Details: 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

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: June 16, 2020
• Study Start: July 2, 2018
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

FR (1)