Eye Movement Desensitization and Reprocessing for Depressed People With Multiple Sclerosis: A Pilot Study

Status unknownNot a drug-phase studyRelapsing and progressiveNCT04875832

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Eye Movement Desensitization and Reprocessing - EMDR

What it measured

Main measures

  • 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)

    Mood and sleep
  • 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)

    Mood and sleep

Other measures (3)

  • 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)

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)
  • Brain MRI

    Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1)

    MRI lesionsNerve conduction tests
  • 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)

    Disability progression

Who could take part

Relapsing and progressive · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      May 2021

    2. Main results due

      Aug 2022

    3. Finished

      Nov 2022

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