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

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder
• Interventions: Other: Eye Movement Desensitization Reprocessing therapy; Behavioral: Trauma-Centred Cognitive and Behavioural Therapy

• Registration Number: NCT04431765
• Lead Sponsor: Centre hospitalier de Ville-Evrard, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-02
• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient for Eye Movement desensitization Reprocessing therapy	Eye Movement Desensitization Reprocessing therapy	Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy
patients for Trauma-Centred Cognitive and Behavioural Therapy	Trauma-Centred Cognitive and Behavioural Therapy	Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy

Primary Outcome Measures

Name	Time	Method
Post Traumatic Stress Scale-5	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.
The Short Form (36) Health Survey (SF36)	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).
Post Traumatic Stress Scale-5 (PCL-5)	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.
Clinical Global Impression (CGI)	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
State Trait Anxiety Inventory (STAI)	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.
Childhood Trauma Questionnaire (CTQ)	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])	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

Trial Locations

Locations (1)

Ch Ville Evrard; 🇫🇷 Neuilly-sur-Marne, France