Eye Movement Desensitization and Reprocessing for Depressed People With Multiple Sclerosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Several studies have reported high rates of depression in people with MS. Depressive symptoms represent a serious threat to quality of life and well-being. Furthermore, findings from the literature suggest that mechanisms underneath depressive features and loss of physical functions in MS could be related. The current study aims at investigating the feasibility of a fairly new type of psychotherapy known as "eye movement desensitization and reprocessing" (EMDR) on depression in people with MS. The goal of this intervention is to reduce the long-lasting effects of distressing memories by developing more adaptive coping mechanisms, through bilateral sensory stimulation. Together with the study on clinical measures, brain mechanisms of change will be assessed with MRI. Fifteen depressed or mildly depressed people with MS will be recruited. Participants will be assessed for depression, and quality of life, before and after the intervention. Participants will also undergo an MRI for brain structural and functional assessments before and after the EMDR intervention. The main aim of the study is to verify that EMDR is a feasible psychotherapeutic approach for people with depression and MS and to collect preliminary data on the efficacy of this type of intervention in reducing the depressive symptoms and improving the quality of life. The study, however, will not be limited to the analysis of outcome differences. The use of MRI assessments, in fact, will allow to explore possible brain change modifications related to depression reduction and/or symptoms modifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of relapsing-remitting or progressive MS.
- •Presence of depressive symptomatology, with HADS scores > 8, confirmed by HDRS scores (clinical interview) >
- •No change of pharmacological treatment in the 3 months before the enrolment.
- •Ability to communicate and to understand tasks.
- •No clinical relapses or use of steroid treatment during the 4 weeks before the enrolment.
- •Provided informed consent for study participation.
排除标准
- •Severe co-morbidity that would reduce life expectancy to less than one year (i.e. end-stage oncological diseases or severe cardiac dysfunction).
- •Severe neuropsychological impairment evaluated with the MMSE.
- •Psychosis or dissociative disorders.
- •No current psychotherapy treatment
- •Pregnancy.
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: Change between the baseline (before EMDR treatment-T0), the end of the EMDR intervention lasting three months (T1) and the follow up at three months after the end of the intervention (T2)
A self-report assessment for anxious and depressive symptoms
Hamilton Depression Rating Scale (HDRS)
时间窗: Change between the baseline (before EMDR treatment-T0), the end of the EMDR intervention lasting three months (T1) and the follow up at three months after the end of the intervention (T2)
clinical structured interview aimed to evaluate the presence of depressive symptoms
次要结局
- Brain MRI(Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1))
- Expanded Disability Status Scale - EDSS Scale(Change between the baseline (before EMDR treatment-T0), the end of the EMDR intervention lasting three months (T1) and the follow up at three months after the end of the intervention (T2))
- Multiple Scleroris Quality of Life - 54, MSQoL-54(Change between the baseline (before EMDR treatment-T0), the end of the EMDR intervention lasting three months (T1) and the follow up at three months after the end of the intervention (T2))