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TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS) (TakeCharge)

This study has been completed.
Information provided by (Responsible Party):
Dawn Ehde, University of Washington Identifier:
First received: July 21, 2009
Last updated: April 6, 2015
Last verified: April 2015

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.

Condition Intervention
Multiple Sclerosis
Behavioral: Self-management intervention
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PHQ 9 [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months ]
  • Brief Pain Inventory [ 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 Outcome Measures:
  • PROMIS Depression Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]
  • PROMIS Pain Impact Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]
  • PROMIS Fatigue Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]

Enrollment: 166
Study Start Date: October 2009
Study Completion Date: September 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
Behavioral: Self-management intervention
Brief counseling technique, self-management,
Active Comparator: Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
Behavioral: Education
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00944190

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: Dawn Ehde, PhD University of Washington
Study Director: George Kraft, MD University of Washington
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dawn Ehde, Professor, Rehabilitation Medicine, University of Washington Identifier: NCT00944190     History of Changes
Other Study ID Numbers: 36021-C
H133B080025 ( Other Grant/Funding Number: NIDRR )
Study First Received: July 21, 2009
Last Updated: April 6, 2015

Keywords provided by University of Washington:
cognitive difficulties

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 24, 2017