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

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University of Washington

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: Education
Behavioral: Self-management intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00944190
36021-C
H133B080025 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

166 participants in 2 patient groups

Self-management Intervention
Experimental group
Description:
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
Treatment:
Behavioral: Self-management intervention
Education
Active Comparator group
Description:
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
Treatment:
Behavioral: Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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