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Stress Management for Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Individual Stress Management
Wait List Control
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Stress, Stress Management, Behavioral Medicine, Multiple Sclerosis, Psychoneuroimmunology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Behavioral Medicine Research Center
  • Northwestern University, Department of Preventive Medicine
  • MS Center at Evergreen Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Individual Stress Management

Wait List Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

No.of Gd+ Lesions From 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

No.of New or Enlarged T2 Lesions From 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.

Full Information

First Posted
September 2, 2005
Last Updated
September 6, 2013
Sponsor
Northwestern University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00147446
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Stress, Stress Management, Behavioral Medicine, Multiple Sclerosis, Psychoneuroimmunology

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Stress Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Stress Management
Other Intervention Name(s)
Cognitive Behavioral Stress Management for MS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wait List Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
No.of Gd+ Lesions From Week 8 to Week 24
Description
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.
Time Frame
week 8 to week 24
Secondary Outcome Measure Information:
Title
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
Description
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.
Time Frame
week 8 to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Mohr, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joyce Ho, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Daikh, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Behavioral Medicine Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Northwestern University, Department of Preventive Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
MS Center at Evergreen Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22786596
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.
Results Reference
background
PubMed Identifier
23680407
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.
Results Reference
derived
PubMed Identifier
23197840
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.
Results Reference
derived

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Stress Management for Patients With Multiple Sclerosis

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