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

Primary Purpose

Post-traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eye Movement Desensitization Reprocessing therapy
Trauma-Centred Cognitive and Behavioural Therapy
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-traumatic Stress Disorder focused on measuring Eye Movement Information- Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ch Ville EvrardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patient for Eye Movement desensitization Reprocessing therapy

patients for Trauma-Centred Cognitive and Behavioural Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
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).
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").
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").
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
April 30, 2020
Last Updated
February 8, 2023
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT04431765
Brief Title
Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Eye Movement Information- Post-traumatic Stress Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient for Eye Movement desensitization Reprocessing therapy
Arm Type
Active Comparator
Arm Description
Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy
Arm Title
patients for Trauma-Centred Cognitive and Behavioural Therapy
Arm Type
Placebo Comparator
Arm Description
Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy
Intervention Type
Other
Intervention Name(s)
Eye Movement Desensitization Reprocessing therapy
Other Intervention Name(s)
EMDR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Centred Cognitive and Behavioural Therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post Traumatic Stress Scale-5 (PCL-5)
Description
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.
Time Frame
Before the therapy begins, at day 0
Title
Post Traumatic Stress Scale-5
Description
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.
Time Frame
Within 3 weeks before the end of the therapy
Title
State Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Before the therapy begins, at day 0
Title
State Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Within 3 weeks before the end of the therapy
Title
The Short Form (36) Health Survey (SF36)
Description
TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).
Time Frame
Before the therapy begins, at day 0
Title
The Short Form (36) Health Survey (SF36)
Description
TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).
Time Frame
Within 3 weeks before the end of the therapy
Title
Childhood Trauma Questionnaire (CTQ)
Description
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").
Time Frame
Before the therapy begins, at day 0
Title
Childhood Trauma Questionnaire (CTQ)
Description
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").
Time Frame
Within 3 weeks before the end of the therapy
Title
Clinician Administered PTSD Scale for DSM-5[CAPS-5])
Description
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
Time Frame
Before the therapy begins, at day 0
Title
Clinician Administered PTSD Scale for DSM-5[CAPS-5])
Description
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
Time Frame
Within 3 weeks before the end of the therapy
Title
Clinical Global Impression (CGI)
Description
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
Time Frame
Before the therapy begins, at day 0
Title
Clinical Global Impression (CGI)
Description
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
Time Frame
Within 3 weeks before the end of the therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rusheenthira THAVASEELAN, Msc
Phone
0143093232
Email
r.thavaseelan@epsve.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Youcef BENCHERIF, MSC
Phone
0143093232
Email
y.bencherif@epsve.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Januel, MBBS
Organizational Affiliation
CHVille Evrard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Durand, MSC
Email
f.durand@epsve.fr
First Name & Middle Initial & Last Name & Degree
Dominique Januel, MBBS

12. IPD Sharing Statement

Learn more about this trial

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

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