NCT00147446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started May 2005

Typical duration for phase_2 multiple-sclerosis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

September 10, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

3.7 years

First QC Date

September 2, 2005

Results QC Date

October 26, 2012

Last Update Submit

September 6, 2013

Conditions

Multiple Sclerosis

Keywords

StressStress ManagementBehavioral MedicineMultiple SclerosisPsychoneuroimmunology

Outcome Measures

Primary Outcomes (1)

  • 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.

    week 8 to week 24

Secondary Outcomes (1)

  • No.of New or Enlarged T2 Lesions From Week 8 to Week 24

    week 8 to week 24

Study Arms (2)

Individual Stress Management

EXPERIMENTAL

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

Wait List Control

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.

Other: Wait List Control

Interventions

Individual Stress ManagementBEHAVIORAL

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.

Also known as: Cognitive Behavioral Stress Management for MS
Individual Stress Management
Wait List ControlOTHER

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.

Wait List Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCSF Behavioral Medicine Research Center

San Francisco, California, 94121, United States

Location

Northwestern University, Department of Preventive Medicine

Chicago, Illinois, 60611, United States

Location

MS Center at Evergreen Medical Center

Kirkland, Washington, 98034, United States

Location

Related Publications (3)

  • 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.

    PMID: 22786596BACKGROUND

  • 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.

    PMID: 23680407DERIVED

  • 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.

    PMID: 23197840DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

we caution that it is premature to make specific clinical recommendations regarding the use of SMT-MS to manage MS disease-related activity. Future work should identify, refine, and optimize the active ingredients in this behavioral intervention.

Results Point of Contact

Title
David C. Mohr
Organization
Northwestern University
m.lisetteluistro@northwestern.edu
312-503-3128

Study Officials

  • David C. Mohr, Ph.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Joyce Ho, PhD

    Northwestern University

    STUDY DIRECTOR

  • David Daikh, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

May 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

September 10, 2013

Results First Posted

September 10, 2013

Record last verified: 2013-09

Locations

US(3)