Clinical trial NCT04875832: EMDR for Depressed People With Multiple Sclerosis
Official title: Eye Movement Desensitization and Reprocessing for Depressed People With Multiple Sclerosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Depression
Keywords: Multiple Sclerosis
Depression
EMDR
Qualiti of life
MRI
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: EMDR Europe
name: Catholic University of the Sacred Heart
First posted: 2021-05-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre versus post EMDR treatment feasibility study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 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)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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)
Secondary outcomes:
measure: Multiple Scleroris Quality of Life - 54, MSQoL-54
timeFrame: 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)
measure: Brain MRI
timeFrame: Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1)
measure: Expanded Disability Status Scale - EDSS Scale
timeFrame: 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)
Other outcomes:
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