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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-management Intervention

Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.

Group Type EXPERIMENTAL

Self-management intervention

Intervention Type BEHAVIORAL

Brief counseling technique, self-management,

Education

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

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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

Interventions

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Self-management intervention

Brief counseling technique, self-management,

Intervention Type BEHAVIORAL

Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No