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

Multiple Sclerosis Clinical Trial

— TakeCharge  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944190
• Other study ID #: 36021-C
• Secondary ID: H133B080025
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: April 6, 2015
• Start date: October 2009
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Self-management intervention
Brief counseling technique, self-management,
• Education
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ 9		Baseline, 5 weeks, 10 weeks, 6 months, and 12 months	No
Primary	Brief Pain Inventory		Baseline, 5 weeks, 10 weeks, 6 months, and 12 months	No
Primary	Modified Fatigue Impact Scale		Baseline, 5 weeks, 10 weeks, 6 months, 12 months	No
Secondary	PROMIS Depression Short Form		Baseline, 5 weeks, 10 weeks, 6 months, 12 months	No
Secondary	PROMIS Pain Impact Short Form		Baseline, 5 weeks, 10 weeks, 6 months, 12 months	No
Secondary	PROMIS Fatigue Short Form		Baseline, 5 weeks, 10 weeks, 6 months, 12 months	No

External Links

•   Webpage for MS Rehabilitation Research and Training Center