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Completed

NCT Number: NCT04300816

Coping and Adjusting to Living With Multiple Sclerosis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT for Uncertainty Tolerance

Behavioral

Participants 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.

Other names: CBT-UT

Traditional CBT

Behavioral

Participants work one-on-one with an interventionist. Treatment sessions focus on goal setting, positive activities, identifying and challenging unhelpful thoughts, and bolstering social support.

Other names: tCBT

Primary outcomes

  1. Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.

    Time frame: 6 Months

    This is a self-reported measure of perceived MS Acceptance. Greater scores represent greater MS Acceptance.

  2. Questionnaire: Level of anxiety as measured by the Global Anxiety Disorder-7 scale (GAD-7).

    Time frame: 6 Months

    This is a self-reported measure of perceived anxiety. Greater scores represent greater levels of anxiety.

  3. Questionnaire: Level of depression as measured by the Patient Health Questionnaire (PHQ-9).

    Time frame: 6 Months

    This is a self-reported measure of perceived depression. Greater scores represent greater levels of depression.

Secondary outcomes

  1. Demographic: MS Progression Type. Measured by self-reported type of MS.

    Time frame: Baseline

    This is a self-reported demographic question. Options include: Relapsing-Remitting, Primary-Progressive, Secondary-Progressive, Progressive-Relapsing, and Don't Know.

  2. Demographic: Biological Sex. Measured by self-report.

    Time frame: Baseline

    This is a self-reported demographic question. Options include: Male, Female, Transgender, and If not listed explain.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

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

Acronym: CALMS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2020
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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