Clinical trial NCT04431765: Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]
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
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Eye Movement Information- Post-traumatic Stress Disorder
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Post Traumatic Stress Scale-5 (PCL-5)
timeFrame: Before the therapy begins, at day 0
measure: Post Traumatic Stress Scale-5
timeFrame: Within 3 weeks before the end of the therapy
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Before the therapy begins, at day 0
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Within 3 weeks before the end of the therapy
measure: The Short Form (36) Health Survey (SF36)
timeFrame: Before the therapy begins, at day 0
measure: The Short Form (36) Health Survey (SF36)
timeFrame: Within 3 weeks before the end of the therapy
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Before the therapy begins, at day 0
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Within 3 weeks before the end of the therapy
measure: Clinician Administered PTSD Scale for DSM-5[CAPS-5])
timeFrame: Before the therapy begins, at day 0
measure: Clinician Administered PTSD Scale for DSM-5[CAPS-5])
timeFrame: Within 3 weeks before the end of the therapy
measure: Clinical Global Impression (CGI)
timeFrame: Before the therapy begins, at day 0
measure: Clinical Global Impression (CGI)
timeFrame: Within 3 weeks before the end of the therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: Ch Ville Evrard
Study officials:
affiliation: CHVille Evrard
name: Dominique Januel, MBBS
role: PRINCIPAL_INVESTIGATOR
References: