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

Centre hospitalier de Ville-Evrard, France

Status: Enrolling

Conditions: Post-traumatic Stress Disorder

Treatments: Other: Eye Movement Desensitization Reprocessing therapy; Behavioral: Trauma-Centred Cognitive and Behavioural Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04431765

10477M-ICE-EMDR

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups, including a placebo group

Patient for Eye Movement desensitization Reprocessing therapy

Active Comparator group

Description:

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

Treatment:

Other: Eye Movement Desensitization Reprocessing therapy

patients for Trauma-Centred Cognitive and Behavioural Therapy

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Trauma-Centred Cognitive and Behavioural Therapy