EMDR for Depressed People With Multiple Sclerosis

NCT04875832 | Unknown

• 1 other identifier: 5_16/10/2019
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Depression

Keywords

Multiple Sclerosis; Depression; EMDR; Qualiti of life; MRI

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HDRS)

  clinical structured interview aimed to evaluate the presence of depressive symptoms

  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

  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

  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

  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

  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)

Study Arms (1)

Intervetion Group

EXPERIMENTAL

EMDR intervention group

Behavioral: Eye Movement Desensitization and Reprocessing - EMDR

Interventions

Eye Movement Desensitization and Reprocessing - EMDR BEHAVIORAL

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

Intervetion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• EMDR Europe: collaborator
• Catholic University of the Sacred Heart: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre versus post EMDR treatment feasibility study

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 6, 2021
• Study Start: May 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-04