Multiple SclerosisNCT04875832
EMDR for Depressed People With Multiple Sclerosis
A study testing Eye Movement Desensitization and Reprocessing - EMDR in people with Multiple Sclerosis and Depression, run by Fondazione Don Carlo Gnocchi ETS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Depression
- What is being tested?
- Eye Movement Desensitization and Reprocessing - EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Eye Movement Desensitization and Reprocessing for Depressed People With Multiple Sclerosis: A Pilot Study
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.
- Conditions
- Multiple Sclerosis, Depression
- Being tested
- Eye Movement Desensitization and Reprocessing - EMDR
- Keywords
- Multiple Sclerosis, Depression, EMDR, Qualiti of life, MRI
- Medical subject headings
- Multiple Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing - EMDRBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervetion Group | Experimental | EMDR intervention group Receives: Behavioral: Eye Movement Desensitization and Reprocessing - EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
clinical structured interview aimed to evaluate the presence of depressive symptoms
Measured: 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)
Hospital Anxiety and Depression Scale (HADS)
A self-report assessment for anxious and depressive symptoms
Measured: 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 (3)
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.
Measured: 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)
Brain MRI
Structural (T1 weigthed 3D and functional MRI (resting state and task activation fMRI)
Measured: Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1)
Expanded Disability Status Scale - EDSS Scale
A method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study startMay 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre versus post EMDR treatment feasibility study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- EMDR Europe, Catholic University of the Sacred Heart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875832
- Sponsor's protocol ID
- 5_16/10/2019
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Movement Desensitization and Reprocessing for Depressed People With Multiple Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT04875832
- Acronym / sponsor ID
- 5_16/10/2019
- Conditions
- Multiple Sclerosis, Depression
- Keywords
- Multiple Sclerosis, Depression, EMDR, Qualiti of life, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- EMDR Europe, Catholic University of the Sacred Heart
- Study start
- May 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre versus post EMDR treatment feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervetion Group | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing - EMDREMDR intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing - EMDREMDR 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 | Behavioural | Intervetion Group |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
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)
clinical structured interview aimed to evaluate the presence of depressive symptoms
Hospital Anxiety and Depression Scale (HADS)
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)
A self-report assessment for anxious and depressive symptoms
3 secondary outcomes
Multiple Scleroris Quality of Life - 54, MSQoL-54
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)
Brain MRI
Time frame: Change between the baseline (before EMDR treatment-T0) and the end of the EMDR intervention lasting three months (T1)
Expanded Disability Status Scale - EDSS Scale
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing - EMDR in people with Multiple Sclerosis and Depression, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.