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Stress Management for Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147446
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
David Mohr, Northwestern University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Individual Stress Management Other: Wait List Control Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes
Study Start Date : May 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Individual Stress Management
Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction.
 Behavioral: Individual Stress Management
Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction.
Other Name: Cognitive Behavioral Stress Management for MS
Wait List Control
Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop.
 Other: Wait List Control
Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop.


Outcome Measures
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Primary Outcome Measures :
  1. No.of Gd+ Lesions From Week 8 to Week 24 [ Time Frame: week 8 to week 24 ]
    Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24.


Secondary Outcome Measures :
  1. No.of New or Enlarged T2 Lesions From Week 8 to Week 24 [ Time Frame: week 8 to week 24 ]
    T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT00147446


Locations
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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
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: David C. Mohr, Ph.D. Northwestern University
Study Director: Joyce Ho, PhD Northwestern University
Principal Investigator: David Daikh, MD University of California, San Francisco
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: David Mohr, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00147446    
Other Study ID Numbers: SIMS
R01HD043323 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2005    Key Record Dates
Results First Posted: September 10, 2013
Last Update Posted: September 10, 2013
Last Verified: September 2013
Keywords provided by David Mohr, Northwestern University:
Stress
Stress Management
Behavioral Medicine
Multiple Sclerosis
Psychoneuroimmunology
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases