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The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01743664
Recruitment Status : Unknown
Verified December 2012 by Pier Maria Furlan, San Luigi Gonzaga Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 7, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Multiple Sclerosis (MS) can be associated to many psychological symptoms. One of the most relevant is the experience of distress related to the disease, that can lead to the development of Post Traumatic Stress Disorder (PTSD). As far as we know there are no studies on the efficacy of psychological treatments in MS in spite of its relevance for patients' quality of life. Primary aim is to evaluate the efficacy of the treatment with Eyes Movement Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective treatment (together with Cognitive Behavioural Therapy) for PTSD according to international guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated symptoms of anxiety and depression and Quality of Life. The study design is a randomized clinical trial. Sixty patients with MS and PTSD will be pre-screened by using the IES-R and the Clinician Administered PTSD Scale. The patients will be randomized in two groups (30 in the experimental group and 30 in the control group).The psychological assessment will be performed in both groups with the same timing and tools: at baseline (T0), after treatment (T1) and 6 months later (T2) by two trained clinical psychologists (independent and blind to treatment) with the CAPS and the administration of self reports: Trauma Antecedent Questionnaire, Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression Scale and Functional Assessment of Multiple Sclerosis. The experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic events. The efficacy will be evaluated comparing the results between T0, T1 and T2 and comparing the scores of the experimental and the control groups. Primary outcome measures will be: 1) the proportion of participants at T1 and T2 no longer meeting the Diagnostic and Statistical Manual (DSM IV-TR) diagnostic criteria for PTSD; 2) the reduction of CAPS scores for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up (avoidance, reexperiencing the traumatic event, hyperarousal and numbing). Secondary outcome measures will be: comparison of the scores of CMDI, HADS and FAMS of the two groups at T0, T1 and T2. The statistical procedure applied will be a repeated measures analysis of covariance both on the primary outcome continuous measures and on the secondary ones.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Multiple Sclerosis Behavioral: EMDR Behavioral: Relaxation Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Post Traumatic Stress Disorder in Multiple Sclerosis. A Randomized Controlled Trial.
Study Start Date : May 2010
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : February 2014

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Arms and Interventions

Arm Intervention/treatment
Experimental: Eye Movement Desesitization Reprocessing
The EMDR protocol follows procedures and phases described by Shapiro (1996). This is a complex treatment that incorporates many different interventions in order to recall trauma-related memories and to subdue them. EMDR processing consists of attending to oscillatory stimulation presented in a visual, auditory or tactile modalities, such as moving the finger from side to side across the patient's visual field or presenting an alternating tapping on the hands alternatively. Eye movements are the most commonly used external stimulus, but if the patient has problems with this kind of stimulation, such as headaches or sensomotor deficits, the therapist chooses tapping as an alternative form of oscillatory stimulation with equivalent therapeutic efficacy.
Behavioral: EMDR
Patients in the experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic events
Active Comparator: relaxation
Relaxation sessions will include diaphragmatic breathing, progressive muscle relaxation, visualisation, and rapid relaxation.
Behavioral: Relaxation
The patients in the control group will undergo 10 weekly relaxation sessions that include diaphragmatic breathing, progressive muscle relaxation, visualization and rapid relaxation.


Outcome Measures

Primary Outcome Measures :
  1. Proportion of participants no longer meeting the DSM IV-TR diagnostic criteria for PTSD among patients of the experimental group in comparison with those of the control group after the treatment. [ Time Frame: Change from Baseline of number of patients meeting the PTSD DSM IV-TR criteria at 3 months ]

Secondary Outcome Measures :
  1. Reduction in the IES scores after the treatment. [ Time Frame: Reduction from Baseline of IES-R score at 3 months ]
  2. Proportion of participants no longer meeting the DSM IV-TR diagnostic criteria for PTSD among patients of the experimental group in comparison with those of the control group at the follow up. [ Time Frame: Change from Baseline of number of patients meeting the PTSD DSM IV-TR criteria at 9 months ]
  3. Reduction in the IES scores at the follow-up. [ Time Frame: Reduction from Baseline of IES-R score at 9 months ]

Other Outcome Measures:
  1. Reduction of PTS-associated symptoms of anxiety and depression and an improvement in quality of life after the treatment. [ Time Frame: Reduction from baseline of PTS-associated symptoms of anxiety and depression and an improvement in quality of life at 3 months. ]
  2. Reduction of PTS-associated symptoms of anxiety and depression and an improvement in quality of life at the follow-up. [ Time Frame: Reduction from baseline of PTS-associated symptoms of anxiety and depression and an improvement in quality of life at 9 months. ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • definite diagnosis of MS (Mc Donald Criteria) evaluated by a neurologist at least six months previously;
  • a relapsing-remitting, primary or secondary progressive disease;
  • clinically inactive phase of the disease;
  • fluent Italian speaker;
  • legal capacity to consent to the treatment;
  • diagnosis of PTSD assessed with the SCID;
  • willingness to suspend all concomitant psychological treatment and suspension of all psychotropic medications at least one month before the treatment or maintenance at baseline level throughout the study.

Exclusion Criteria:

  • other serious mental disorders, including bipolar disorders, psychotic symptoms, substance abuse, suicidal tendency or cognitive impairment;
  • in corticosteroid treatment during the previous month;
  • with other serious medical disorders in addition to MS.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743664


Contacts
Contact: Luca Ostacoli, M.D. 0039 0119026664 luca.ostacoli@unito.it

Locations
Italy
San Luigi Gonzaga University Hospital Recruiting
Orbassano, Torino, Italy, 10043
Principal Investigator: Luca Ostacoli, M.D.         
Sponsors and Collaborators
San Luigi Gonzaga Hospital
Fondazione Italiana Sclerosi Multipla
Investigators
Principal Investigator: Pier M Furlan, M.D. San Luigi Gonzaga University Hospital
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pier Maria Furlan, Head of the Faculty of Medicine and Surgery San Luigi Gonzaga, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier: NCT01743664     History of Changes
Other Study ID Numbers: 2009/R/11
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Pier Maria Furlan, San Luigi Gonzaga Hospital:
Posttraumatic Stress Disorders
Multiple Sclerosis
Eye Movement Desensitization Reprocessing
Psychotherapy
Anxiety
Depression
Quality of Life

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Trauma and Stressor Related Disorders
Mental Disorders