The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis

NCT01743664 | Unknown Phase 3

• 1 other identifier: 2009/R/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorders; Multiple Sclerosis

Keywords

Posttraumatic Stress Disorders; Multiple Sclerosis; Eye Movement Desensitization Reprocessing; Psychotherapy; Anxiety; Depression; Quality of Life

Outcome Measures

Primary Outcomes (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.

  Change from Baseline of number of patients meeting the PTSD DSM IV-TR criteria at 3 months

Secondary Outcomes (3)

• Reduction in the IES scores after the treatment.

  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.

  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.

  Reduction from Baseline of IES-R score at 9 months

Other Outcomes (2)

• 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.

• 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.

Study Arms (2)

Eye Movement Desesitization Reprocessing

EXPERIMENTAL

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

relaxation

ACTIVE COMPARATOR

Relaxation sessions will include diaphragmatic breathing, progressive muscle relaxation, visualisation, and rapid relaxation.

Behavioral: Relaxation

Interventions

EMDR BEHAVIORAL

Patients in the experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic events

Eye Movement Desesitization Reprocessing

Relaxation BEHAVIORAL

The patients in the control group will undergo 10 weekly relaxation sessions that include diaphragmatic breathing, progressive muscle relaxation, visualization and rapid relaxation.

relaxation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead
• Fondazione Italiana Sclerosi Multipla: collaborator

Study Sites (1)

San Luigi Gonzaga University Hospital

Orbassano, Torino, 10043, Italy

RECRUITING

Related Publications (6)

• Chalfant AM, Bryant RA, Fulcher G. Posttraumatic stress disorder following diagnosis of multiple sclerosis. J Trauma Stress. 2004 Oct;17(5):423-8. doi: 10.1023/B:JOTS.0000048955.65891.4c.

  PMID: 15633921 BACKGROUND

• 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. doi: 10.1192/bjp.bp.106.021402.

  PMID: 17267924 BACKGROUND

• 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. doi: 10.1016/s0272-7358(01)00118-0.

  PMID: 12094509 BACKGROUND

• Tedstone JE, Tarrier N. Posttraumatic stress disorder following medical illness and treatment. Clin Psychol Rev. 2003 May;23(3):409-48. doi: 10.1016/s0272-7358(03)00031-x.

  PMID: 12729679 BACKGROUND

• 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. J Clin Psychol Med Settings. 2013 Jun;20(2):240-6. doi: 10.1007/s10880-012-9323-2.

  PMID: 23053829 RESULT

• Carletto S, Borghi M, Bertino G, Oliva F, Cavallo M, Hofmann A, Zennaro A, Malucchi S, Ostacoli L. Treating Post-traumatic Stress Disorder in Patients with Multiple Sclerosis: A Randomized Controlled Trial Comparing the Efficacy of Eye Movement Desensitization and Reprocessing and Relaxation Therapy. Front Psychol. 2016 Apr 21;7:526. doi: 10.3389/fpsyg.2016.00526. eCollection 2016.

  PMID: 27148134 DERIVED

Related Links

• link to the Italian Association of Multiple Sclerosis and to its Research Foundation

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Multiple Sclerosis; Anxiety Disorders; Depression

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; 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 Officials

• Pier M Furlan, M.D.

  San Luigi Gonzaga University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Ostacoli, M.D.

CONTACT

0039 0119026664; luca.ostacoli@unito.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Faculty of Medicine and Surgery San Luigi Gonzaga

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: December 6, 2012
• Study Start: May 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: February 1, 2014
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

IT (1)