Coping and Adjusting to Living With Multiple Sclerosis (CALMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: CBT for Uncertainty Tolerance; Behavioral: Traditional CBT

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 Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-UT; Seven telephone-based sessions of cognitive behavioral therapy for uncertainty tolerance (CBT-UT) delivered over seven weeks.	Behavioral: CBT for Uncertainty Tolerance; 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
Active Comparator: tCBT; Seven telephone-based sessions of traditional cognitive behavioral therapy (tCBT) delivered over seven weeks.	Behavioral: Traditional CBT; 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
No Intervention: TAU; Participant continues with their lives as they normally would.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Multiple Sclerosis Society
• Investigators: Principal Investigator: Ivan Molton, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: STUDY00007984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators propose to make available to interested researchers a data file (de-identified to remove any variables from which it would be possible to identify any individual participant) any data used in a published article, at the time that it is accepted for publication. That is, at the request of an outside researcher, the investigators will create and share a data file that includes all of the variables used in the published article and a list of the variables in the data file (along with their variable labels). Any investigators who request these data will receive (1) a copy of the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a data set.
• IPD Sharing Time Frame: Data will become available after the main study results are published.
• IPD Sharing Access Criteria: Although any shared data will be stripped of identifiers prior to release, given the very specific nature of the study sample (individuals who have had a recent diagnosis of MS) it is possible that those who access this data could potentially identify subjects with unusual characteristics or combinations of unusual characteristics. Therefore, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No