TakeCharge: Telephone Delivered Self-management Intervention for Peopl

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

CompletedNot a drug-phase studyMS (type not specified)NCT00944190

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Self-management intervention

Compared with

  • Education

What it measured

Main measures

  • 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

    Pain

  • Modified Fatigue Impact Scale

    Baseline, 5 weeks, 10 weeks, 6 months, 12 months

    Fatigue

Other measures (3)

  • PROMIS Depression Short Form

    Baseline, 5 weeks, 10 weeks, 6 months, 12 months

    Mood and sleep

  • PROMIS Pain Impact Short Form

    Baseline, 5 weeks, 10 weeks, 6 months, 12 months

    Pain

  • PROMIS Fatigue Short Form

    Baseline, 5 weeks, 10 weeks, 6 months, 12 months

    Fatigue

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Oct 2009

    2. Main results due

      Dec 2012

    3. Finished

      Sept 2013

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