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Completed

NCT Number: NCT00944190

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Fatigue Immune System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-management Intervention

Behavioral

Brief counseling technique, self-management,

Education

Behavioral

Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.

Primary outcomes

  1. PHQ 9

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

  2. Brief Pain Inventory

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

  3. Modified Fatigue Impact Scale

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

Secondary outcomes

  1. PROMIS Depression Short Form

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

  2. PROMIS Pain Impact Short Form

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

  3. PROMIS Fatigue Short Form

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Acronym: TakeCharge

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jul 23, 2009
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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