Multiple Sclerosis Clinical Trial

Coping and Adjusting to Living With Multiple Sclerosis

Summary

The purpose of this project is to test a brief, telephone-based psychological intervention, CBT-UT, to improve the ability to tolerate uncertainty-and thereby to reduce distress-in people with a recent diagnosis of Multiple Sclerosis (MS). There are three treatment arms for this study. Participants will receive either (1) CBT for Uncertainty Tolerance, (2) Traditional CBT, or (3) treatment as usual.

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Full Description

Despite substantial improvements in diagnosis and treatment, Multiple Sclerosis (MS) remains an unpredictable disease. Although some physicians can make some predictions about expected progression, the variable course of exacerbations makes it almost impossible to predict how MS will develop or affect function over time. As a result, people with MS must learn to live in a state of chronic uncertainty and the ability to tolerate and cope with this kind of uncertainty is central to quality of life with MS. Individuals who require certainty about the future and are not able to tolerate ambiguity are said to be high in a personality trait known as intolerance of uncertainty (IU). There is a significant gap in MS clinical intervention that necessitates attention. An intervention that specifically targets IU, is developed for people recently diagnosed with MS, and can be provided remotely via telehealth can make a significant impact for this population. Study aims include: (1) to determine the efficacy of CBT-UT relative to traditional cognitive behavioral therapy (tCBT) or treatment as usual (TAU) in people diagnosed with MS in the past 3 years; and (2) To increase our understanding of the mechanisms underlying the intervention effects.

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Eligibility Criteria

Inclusion Criteria:

Adults over 18 years of age
MS diagnosis using revised McDonald Criteria
Able to read, speak, and understand English
At least mild psychological distress evidenced by (1) a score of 20 or higher on the Kessler Psychological Distress Scale OR (2) a score greater than or equal to 5 on the Perceived Stress Scale.

Exclusion Criteria:

Severe cognitive impairment defined as one or more error on the Six-Item Screener
Psychiatric condition or symptoms that would interfere with participation, specifically (1) current, active suicidal ideation with current intent to harm oneself, (2) current psychosis, or (3) current mania.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

242

Study ID:

NCT04300816

Recruitment Status:

Completed

Sponsor:

University of Washington

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There is 1 Location for this study

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University of Washington
Seattle Washington, 98195, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

242

Study ID:

NCT04300816

Recruitment Status:

Completed

Sponsor:


University of Washington

How clear is this clinincal trial information?

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