Clinical trial NCT00147446: Stress Management for Patients With Multiple Sclerosis
Official title: Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Stress
Stress Management
Behavioral Medicine
Multiple Sclerosis
Psychoneuroimmunology
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-09-07
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: No.of Gd+ Lesions From Week 8 to Week 24
timeFrame: week 8 to week 24
Secondary outcomes:
measure: No.of New or Enlarged T2 Lesions From Week 8 to Week 24
timeFrame: week 8 to week 24
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Behavioral Medicine Research Center
state: California
city: Chicago
country: United States
facility: Northwestern University, Department of Preventive Medicine
state: Illinois
city: Kirkland
country: United States
facility: MS Center at Evergreen Medical Center
state: Washington
Study officials:
affiliation: Northwestern University
name: David C. Mohr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Joyce Ho, PhD
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: David Daikh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohr DC, Lovera J, Brown T, Cohen B, Neylan T, Henry R, Siddique J, Jin L, Daikh D, Pelletier D. A randomized trial of stress management for the prevention of new brain lesions in MS. Neurology. 2012 Jul 31;79(5):412-9. doi: 10.1212/WNL.0b013e3182616ff9. Epub 2012 Jul 11.
citation: Burns MN, Nawacki E, Kwasny MJ, Pelletier D, Mohr DC. Do positive or negative stressful events predict the development of new brain lesions in people with multiple sclerosis? Psychol Med. 2014 Jan;44(2):349-59. doi: 10.1017/S0033291713000755. Epub 2013 May 17.
citation: Burns MN, Nawacki E, Siddique J, Pelletier D, Mohr DC. Prospective examination of anxiety and depression before and during confirmed and pseudoexacerbations in patients with multiple sclerosis. Psychosom Med. 2013 Jan;75(1):76-82. doi: 10.1097/PSY.0b013e3182757b2b. Epub 2012 Nov 28.