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

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 |

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.
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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
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Active Comparator: relaxation
Relaxation sessions will include diaphragmatic breathing, progressive muscle relaxation, visualisation, and rapid relaxation.
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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.
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- 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 ]
- Reduction in the IES scores after the treatment. [ Time Frame: Reduction from Baseline of IES-R score at 3 months ]
- 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 ]
- Reduction in the IES scores at the follow-up. [ Time Frame: Reduction from Baseline of IES-R score at 9 months ]
- 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. ]
- 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. ]

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

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
Contact: Luca Ostacoli, M.D. | 0039 0119026664 | luca.ostacoli@unito.it |
Italy | |
San Luigi Gonzaga University Hospital | Recruiting |
Orbassano, Torino, Italy, 10043 | |
Principal Investigator: Luca Ostacoli, M.D. |
Principal Investigator: | Pier M Furlan, M.D. | San Luigi Gonzaga University Hospital |
Additional Information:
Publications of Results:
Other 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 |