Post-traumatic Stress DisorderICE-EMDRNCT04431765
Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]
A study testing Eye Movement Desensitization Reprocessing therapy and Trauma-Centred Cognitive and Behavioural Therapy in people with Post-traumatic Stress Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Eye Movement Desensitization Reprocessing therapy and Trauma-Centred Cognitive and Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2018to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Ch Ville Evrard
Neuilly-sur-Marne, 93330
Florence Durand, MSC, f.durand@epsve.fr
Dominique Januel, MBBS
About this study
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.
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
- Being tested
- Eye Movement Desensitization Reprocessing therapy, Trauma-Centred Cognitive and Behavioural Therapy
- Keywords
- Eye Movement Information- Post-traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization Reprocessing therapyOther
Also called EMDR
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.
Trauma-Centred Cognitive and Behavioural TherapyBehavioural
Also called CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient for Eye Movement desensitization Reprocessing therapy | Active comparator | Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy Receives: 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 Receives: Behavioral: Trauma-Centred Cognitive and Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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").
Measured: 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").
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 3 weeks before the end of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start2 Jul 2018
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Januel, Centre hospitalier de Ville-Evrard, France
- Investigators
- Dominique Januel, MBBS, Principal investigator, CHVille Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431765
- Sponsor's protocol ID
- 10477M-ICE-EMDR
- Acronym
- ICE-EMDR
- Status last verified
- Feb 2023
- First submitted
- 30 Apr 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04431765
- Acronym / sponsor ID
- ICE-EMDR / 10477M-ICE-EMDR
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Eye Movement Information- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Patient for Eye Movement desensitization Reprocessing therapy | Active comparator | Other: Eye Movement Desensitization Reprocessing therapyPatient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy |
| patients for Trauma-Centred Cognitive and Behavioural Therapy | Placebo comparator | Behavioral: Trauma-Centred Cognitive and Behavioural TherapyPatients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization Reprocessing therapyAlso: EMDRThe 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 | Patient for Eye Movement desensitization Reprocessing therapy |
| Trauma-Centred Cognitive and Behavioural TherapyAlso: CBTA 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. | Behavioural | patients for Trauma-Centred Cognitive and Behavioural Therapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Januel, MBBS principal investigator
CHVille Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization Reprocessing therapy and Trauma-Centred Cognitive and Behavioural Therapy in people with Post-traumatic Stress Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rusheenthira THAVASEELAN, Msc (0143093232, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Stress Scale-5 (PCL-5) (time frame: Before the therapy begins, at day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.