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Clinical Trials/NCT00944190
NCT00944190
Completed
Not Applicable

Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties

University of Washington1 site in 1 country166 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Washington
Enrollment
166
Locations
1
Primary Endpoint
Brief Pain Inventory
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).

It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
September 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dawn Ehde

Professor, Rehabilitation Medicine

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Must be diagnosed with MS by a physician.
  • Must be at least 18 years of age.
  • Must be able to understand, speak, and read English.
  • Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.

Exclusion Criteria

  • Unable to understand or read English.
  • Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
  • Currently participating in regularly scheduled psychotherapy.
  • Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.

Outcomes

Primary Outcomes

Brief Pain Inventory

Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months

PHQ 9

Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months

Modified Fatigue Impact Scale

Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months

Secondary Outcomes

  • PROMIS Fatigue Short Form(Baseline, 5 weeks, 10 weeks, 6 months, 12 months)
  • PROMIS Depression Short Form(Baseline, 5 weeks, 10 weeks, 6 months, 12 months)
  • PROMIS Pain Impact Short Form(Baseline, 5 weeks, 10 weeks, 6 months, 12 months)

Study Sites (1)

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