EMDR for Depressed People With Multiple Sclerosis
- Conditions
- Multiple SclerosisDepression
- Interventions
- Behavioral: Eye Movement Desensitization and Reprocessing - EMDR
- Registration Number
- NCT04875832
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- Diagnosis of relapsing-remitting or progressive MS.
- Presence of depressive symptomatology, with HADS scores > 8, confirmed by HDRS scores (clinical interview) > 14.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervetion Group Eye Movement Desensitization and Reprocessing - EMDR EMDR intervention group
- Primary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) 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) 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
- Secondary Outcome Measures
Name Time Method Brain MRI Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1) Structural (T1 weigthed 3D and functional MRI (resting state and task activation fMRI)
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) A method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability.
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) A multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. It is composed by 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.