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Stress Management for Patients With Multiple Sclerosis

NCT00147446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2013-09-10

Study results available
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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.

Conditions

Interventions

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

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • David C. Mohr, Ph.D. · Northwestern University

  • Joyce Ho, PhD · Northwestern University

  • David Daikh, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00147446 on ClinicalTrials.gov