Coping and Adjusting to Living With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: CBT for Uncertainty Tolerance; Behavioral: Traditional CBT

• Registration Number: NCT04300816
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-09
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-UT	CBT for Uncertainty Tolerance	Seven telephone-based sessions of cognitive behavioral therapy for uncertainty tolerance (CBT-UT) delivered over seven weeks.
tCBT	Traditional CBT	Seven telephone-based sessions of traditional cognitive behavioral therapy (tCBT) delivered over seven weeks.

Primary Outcome Measures

Name	Time	Method
Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.	6 Months	This is a self-reported measure of perceived MS Acceptance. Greater scores represent greater MS Acceptance.
Questionnaire: Level of depression as measured by the Patient Health Questionnaire (PHQ-9).	6 Months	This is a self-reported measure of perceived depression. Greater scores represent greater levels of depression.
Questionnaire: Level of anxiety as measured by the Global Anxiety Disorder-7 scale (GAD-7).	6 Months	This is a self-reported measure of perceived anxiety. Greater scores represent greater levels of anxiety.

Secondary Outcome Measures

Name	Time	Method
Demographic: MS Progression Type. Measured by self-reported type of MS.	Baseline	This is a self-reported demographic question. Options include: Relapsing-Remitting, Primary-Progressive, Secondary-Progressive, Progressive-Relapsing, and Don't Know.
Demographic: Biological Sex. Measured by self-report.	Baseline	This is a self-reported demographic question. Options include: Male, Female, Transgender, and If not listed explain.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States