Multiple Sclerosis Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2014 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | San Luigi Gonzaga University Hospital | Orbassano | Torino |
Lead Sponsor | Collaborator |
---|---|
San Luigi Gonzaga Hospital | Fondazione Italiana Sclerosi Multipla |
Italy,
Bisson JI, Ehlers A, Matthews R, Pilling S, Richards D, Turner S. Psychological treatments for chronic post-traumatic stress disorder. Systematic review and meta-analysis. Br J Psychiatry. 2007 Feb;190:97-104. Review. — View Citation
Chalfant AM, Bryant RA, Fulcher G. Posttraumatic stress disorder following diagnosis of multiple sclerosis. J Trauma Stress. 2004 Oct;17(5):423-8. — View Citation
Kangas M, Henry JL, Bryant RA. Posttraumatic stress disorder following cancer. A conceptual and empirical review. Clin Psychol Rev. 2002 May;22(4):499-524. Review. — View Citation
Ostacoli L, Carletto S, Borghi M, Cavallo M, Rocci E, Zuffranieri M, Malucchi S, Bertolotto A, Zennaro A, Furlan PM, Picci RL. Prevalence and significant determinants of post-traumatic stress disorder in a large sample of patients with multiple sclerosis. — View Citation
Tedstone JE, Tarrier N. Posttraumatic stress disorder following medical illness and treatment. Clin Psychol Rev. 2003 May;23(3):409-48. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reduction of PTS-associated symptoms of anxiety and depression and an improvement in quality of life after the treatment. | Reduction from baseline of PTS-associated symptoms of anxiety and depression and an improvement in quality of life at 3 months. | No | |
Other | Reduction of PTS-associated symptoms of anxiety and depression and an improvement in quality of life at the follow-up. | Reduction from baseline of PTS-associated symptoms of anxiety and depression and an improvement in quality of life at 9 months. | No | |
Primary | 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. | Change from Baseline of number of patients meeting the PTSD DSM IV-TR criteria at 3 months | No | |
Secondary | Reduction in the IES scores after the treatment. | Reduction from Baseline of IES-R score at 3 months | No | |
Secondary | 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. | Change from Baseline of number of patients meeting the PTSD DSM IV-TR criteria at 9 months | No | |
Secondary | Reduction in the IES scores at the follow-up. | Reduction from Baseline of IES-R score at 9 months | No |
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