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

Study Overview
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Self-management intervention
* Behavioral: Education


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management Intervention<br>Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties. | Behavioral: Self-management intervention<br>* Brief counseling technique, self-management,<br>|
| Active Comparator: Education<br>Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis. | Behavioral: Education<br>* Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Modified Fatigue Impact Scale |  | Baseline, 5 weeks, 10 weeks, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Depression Short Form |  | Baseline, 5 weeks, 10 weeks, 6 months, 12 months | 
| PROMIS Pain Impact Short Form |  | Baseline, 5 weeks, 10 weeks, 6 months, 12 months | 
| PROMIS Fatigue Short Form |  | Baseline, 5 weeks, 10 weeks, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, fatigue, depression, cognitive difficulties, self-management