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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Post Traumatic Stress Scale-5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Post Traumatic Stress Scale-5
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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])
时间窗: 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
次要结局
未报告次要终点
研究者
Januel
Head of the clinical research department (psychiatrist)
Centre hospitalier de Ville-Evrard, France