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

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
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
NCT ID
NCT04875832
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
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
Learn more about this trial
EMDR for Depressed People With Multiple Sclerosis
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