Clinical trial NCT00944190: TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS)
Official title: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: pain
fatigue
depression
cognitive difficulties
self-management
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: PHQ 9
timeFrame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
measure: Brief Pain Inventory
timeFrame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
measure: Modified Fatigue Impact Scale
timeFrame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Secondary outcomes:
measure: PROMIS Depression Short Form
timeFrame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
measure: PROMIS Pain Impact Short Form
timeFrame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
measure: PROMIS Fatigue Short Form
timeFrame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Dawn Ehde, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: George Kraft, MD
role: STUDY_DIRECTOR
References:
citation: Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
citation: Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
citation: Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.