Stress Management for Patients With Multiple Sclerosis - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00147446

Purpose

There is a growing body of literature showing that stressful life events can increase the risk of developing exacerbations and new brain lesions among people with multiple sclerosis. The purpose of this study is to examine the hypothesis that stress management programs can reduce the occurrence of new brain lesions and exacerbations. We will also examine potential immune and neuroendocrine pathways.

Condition	Intervention	Phase
Multiple Sclerosis	Behavioral: Cognitive Behavioral Stress Management for MS Behavioral: Wait List Control	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

MRI [ Time Frame: baseline, and months 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
Exacerbation rate based on patient report and verification by neurologist. [ Time Frame: Ongoing throughout participation ] [ Designated as safety issue: No ]
EDSS & MSFC [ Time Frame: baseline, month 4, month 8 and month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: baseline, month 4, month 8 and month 12 ] [ Designated as safety issue: No ]
Interaction between stress and MRI outcomes [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
Interaction between stress and clinical (EDSS, exacerbation) outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2005
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Individual Cognitive Behavioral Stress Management	Behavioral: Cognitive Behavioral Stress Management for MS 16 weekly meetings with a health psychologist
2: No Intervention Wait List Control	Behavioral: Wait List Control 1-Day workshop that occurs at the end of the trial containing all intervention information

Detailed Description:

MS is a frequently disabling autoimmune disease affecting approximately 350,000 people in the United States. More than two decades of research has consistently shown a relationship between stressful life events (SLEs), in particular non-traumatic family and work stressors, and subsequent clinical exacerbation. Furthermore, we have shown that non-traumatic SLEs increase the risk of the subsequent appearance of new gadolinium enhancing (Gd+) magnetic resonance imaging (MRI) brain lesions, an early marker of MS inflammation and blood-brain barrier (BBB) breakdown. The purpose of this study is to determine the efficacy of cognitive behavioral stress management for MS (CBSM-MS) in reducing the occurrence of new brain lesions in people with relapsing forms of MS. Patients must have a documented new Gd+ MRI brain lesion or clinical exacerbation within the previous 12 months to be enrolled.

One hundred and twelve patients will be enrolled for 12 months. Patients will be randomly assigned to either an intensive CBSM-MS program, consisting of 16 individual meetings with a behavioral medicine specialist, or a condensed CBSM-MS program, consisting of a one-day workshop offered after the 10th month of participation.

Outcomes include MRI, clinical neurological end-points, and psychosocial functioning. We will also enhance our understanding of mechanisms by examining potential psychosocial, immune, and endocrine mediators of the relationship between SLEs and clinical and neuroimaging markers of MS inflammation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of MS
New Gd+ MRI brain lesion or clinically diagnosed exacerbation within the previous 12 months.
Able to speak english.
Age 18 or over.
Able to give informed consent.
Patients taking the drug glatiramer acetate must have been on the drug for at least 6 months prior to their Gd+ MRI brain lesion and/or exacerbation.
Patients taking an interferon beta drug must have been on the drug for at least 1 month prior to their Gd+ MRI brain lesion and/or exacerbation.
Patients not on disease modifying treatment are not planning to initiate treatment.

Exclusion Criteria:

Meets criteria for dementia by scoring below the 5th percentile in 3 or more of 6 areas of neuropsychological functioning or as determined by study neuropsychologist.
Severe psychiatric pathology, including schizophrenia, bipolar disorder, current alcoholism or substance abuse, or other severe psychiatric disorder for which this intervention would be inappropriate.
Active and severe suicidal ideation.
Endocrine or metabolic disorder.
Currently in psychotherapy.
Initiated antidepressant therapy within the past 4 weeks.
Received corticosteroid treatment within the past 28 days.
Pregnant or planning pregnancy in the next 12 months.
Has any non-removable metal or medical device in the body for which an MRI could pose a danger.
Has any risk factors for developing nephrogenic systemic fibrosis (NSF) or is allergic to Gadolinium.
Currently uses a Baclofen pump.
Has an Expanded Disability Status Scale score greater than 6.5.
Recently begun relaxation, meditation, yoga, or similar form of disease management course within the past 3 months.
Treatment with Chemotherapy.
Treatment with Tysabri.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147446

Locations

United States, California
UCSF Behavioral Medicine Research Center
San Francisco, California, United States, 94121
United States, Illinois
Northwestern University, Department of Preventive Medicine
Chicago, Illinois, United States, 60611
United States, Washington
MS Center at Evergreen Medical Center
Kirkland, Washington, United States, 98034

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	David C. Mohr, Ph.D.	Northwestern University
Study Director:	Emily Gagen	Northwestern University
Principal Investigator:	David Daikh, MD	University of California, San Francisco

More Information

No publications provided

Responsible Party:	Northwestern University ( David C. Mohr, Ph.D./Professor )
Study ID Numbers:	SIMS, R01 HD043323
Study First Received:	September 2, 2005
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00147446 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Stress
Stress Management
Behavioral Medicine
Multiple Sclerosis
Psychoneuroimmunology

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Stress
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on September 04, 2009