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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00944190
Acronym
TakeCharge
Enrollment
166
Registered
2009-07-23
Start date
2009-10-31
Completion date
2013-09-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

pain, fatigue, depression, cognitive difficulties, self-management

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.

Interventions

Brief counseling technique, self-management,

BEHAVIORALEducation

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

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
PHQ 9Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Brief Pain InventoryBaseline, 5 weeks, 10 weeks, 6 months, and 12 months
Modified Fatigue Impact ScaleBaseline, 5 weeks, 10 weeks, 6 months, 12 months

Secondary

MeasureTime frame
PROMIS Depression Short FormBaseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Pain Impact Short FormBaseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Fatigue Short FormBaseline, 5 weeks, 10 weeks, 6 months, 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026