Stress Management for Patients With Multiple Sclerosis

NCT ID: NCT00147446

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-01-31

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.

Conditions

Multiple Sclerosis

Keywords

Stress; Stress Management; Behavioral Medicine; Multiple Sclerosis; Psychoneuroimmunology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Individual Stress Management

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Wait List Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Cognitive Behavioral Stress Management for MS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Mohr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David C. Mohr, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Joyce Ho, PhD

Role: STUDY_DIRECTOR

Northwestern University

David Daikh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Behavioral Medicine Research Center

San Francisco, California, United States

Northwestern University, Department of Preventive Medicine

Chicago, Illinois, United States

MS Center at Evergreen Medical Center

Kirkland, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22786596 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23680407 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23197840 (View on PubMed)

Other Identifiers

R01HD043323

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SIMS

Identifier Type: -

Identifier Source: org_study_id