Clinical Trials Directory

Trials / Completed

CompletedNCT04300816

Coping and Adjusting to Living With Multiple Sclerosis

Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
242 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCBT for Uncertainty ToleranceParticipants work one-on-one with an interventionist. Treatment sessions focus on understanding the difference between the controllable and uncontrollable aspects of MS, ability to tolerate not knowing exactly what the future will hold, setting personal goals for what "accepting" what MS will look like, and finding ways to live in conjunction with personal values despite the MS diagnosis.
BEHAVIORALTraditional CBTParticipants work one-on-one with an interventionist. Treatment sessions focus on goal setting, positive activities, identifying and challenging unhelpful thoughts, and bolstering social support.

Timeline

Start date
2019-10-30
Primary completion
2022-11-11
Completion
2022-11-11
First posted
2020-03-09
Last updated
2023-06-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04300816. Inclusion in this directory is not an endorsement.