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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Education; Behavioral: Self-management intervention

• Registration Number: NCT00944190
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-23
• Study Start: 2009-10
• Primary Completion: 2012-12
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Education	Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
Self-management Intervention	Self-management intervention	Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.

Primary Outcome Measures

Name	Time	Method
PHQ 9	Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Brief Pain Inventory	Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Modified Fatigue Impact Scale	Baseline, 5 weeks, 10 weeks, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
PROMIS Depression Short Form	Baseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Fatigue 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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States