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

NCT ID: NCT04431765

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2026-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient for Eye Movement desensitization Reprocessing therapy

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

Group Type: ACTIVE_COMPARATOR

Eye Movement Desensitization Reprocessing therapy

Intervention Type: 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.

patients for Trauma-Centred Cognitive and Behavioural Therapy

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

Group Type: PLACEBO_COMPARATOR

Trauma-Centred Cognitive and Behavioural Therapy

Intervention Type: 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.

Interventions

Eye Movement Desensitization Reprocessing therapy

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: OTHER

Trauma-Centred Cognitive and Behavioural Therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EMDR; CBT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role: lead

Responsible Party

Januel

Head of the clinical research department (psychiatrist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique Januel, MBBS

Role: PRINCIPAL_INVESTIGATOR

CHVille Evrard

Locations

Ch Ville Evrard

Neuilly-sur-Marne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Rusheenthira THAVASEELAN, Msc

Role: CONTACT

r.thavaseelan@epsve.fr

0143093232

Youcef BENCHERIF, MSC

Role: CONTACT

y.bencherif@epsve.fr

0143093232

Facility Contacts

Florence Durand, MSC

Role: primary

f.durand@epsve.fr

Other Identifiers

10477M-ICE-EMDR

Identifier Type: -

Identifier Source: org_study_id