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EMDR for Depressed People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing - EMDR
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Depression, EMDR, Qualiti of life, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervetion Group

    Arm Description

    EMDR intervention group

    Outcomes

    Primary Outcome Measures

    Hamilton Depression Rating Scale (HDRS)
    clinical structured interview aimed to evaluate the presence of depressive symptoms
    Hospital Anxiety and Depression Scale (HADS)
    A self-report assessment for anxious and depressive symptoms

    Secondary Outcome Measures

    Multiple Scleroris Quality of Life - 54, MSQoL-54
    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.
    Brain MRI
    Structural (T1 weigthed 3D and functional MRI (resting state and task activation fMRI)
    Expanded Disability Status Scale - EDSS Scale
    A method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability.

    Full Information

    First Posted
    April 28, 2021
    Last Updated
    May 5, 2021
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    EMDR Europe, Catholic University of the Sacred Heart
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04875832
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    EMDR Europe, Catholic University of the Sacred Heart

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Depression
    Keywords
    Multiple Sclerosis, Depression, EMDR, Qualiti of life, MRI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pre versus post EMDR treatment feasibility study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervetion Group
    Arm Type
    Experimental
    Arm Description
    EMDR intervention group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Eye Movement Desensitization and Reprocessing - EMDR
    Intervention Description
    EMDR is a comprehensive psychotherapy approach, originally developed to treat the victims of trauma. EMDR is guided by an information processing model known as the Adaptive Information Processing (AIP) model. One of the key assumptions of the AIP model is that dysfunctionally stored (disturbing) memories are the cause of several mental pathologies. EMDR is therefore used to address a range of complaints that follow distressing life experiences and it is characterized by an eight-phase psychotherapy approach. The intervention is based on the use of bilateral stimulation (e.g., taps, tones, or eye movements), which aims to stimulate the information processing system of the brain in combination with other methods of established psychotherapies. EMDR is widely recognized as an empirically supported treatment for post-traumatic stress disorder (PTSD) and it is one of the best psychological treatment focused on the ri-processing of recent traumatic experiences
    Primary Outcome Measure Information:
    Title
    Hamilton Depression Rating Scale (HDRS)
    Description
    clinical structured interview aimed to evaluate the presence of depressive symptoms
    Time Frame
    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)
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    A self-report assessment for anxious and depressive symptoms
    Time Frame
    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 Outcome Measure Information:
    Title
    Multiple Scleroris Quality of Life - 54, MSQoL-54
    Description
    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.
    Time Frame
    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)
    Title
    Brain MRI
    Description
    Structural (T1 weigthed 3D and functional MRI (resting state and task activation fMRI)
    Time Frame
    Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1)
    Title
    Expanded Disability Status Scale - EDSS Scale
    Description
    A method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability.
    Time Frame
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    EMDR for Depressed People With Multiple Sclerosis

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