Coping and Adjusting to Living With Multiple Sclerosis (CALMS)

University of Washington

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Traditional CBT; Behavioral: CBT for Uncertainty Tolerance

Study type: Interventional

Funder types: Other

Identifiers

NCT04300816

STUDY00007984

Details and patient eligibility

About

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.

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.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 3 patient groups

CBT-UT

Experimental group

Description:

Seven telephone-based sessions of cognitive behavioral therapy for uncertainty tolerance (CBT-UT) delivered over seven weeks.

Treatment:

Behavioral: CBT for Uncertainty Tolerance

tCBT

Active Comparator group

Description:

Seven telephone-based sessions of traditional cognitive behavioral therapy (tCBT) delivered over seven weeks.

Treatment:

Behavioral: Traditional CBT

TAU

No Intervention group

Description:

Participant continues with their lives as they normally would.