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Coping and Adjusting to Living With Multiple Sclerosis (CALMS)

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ClinicalTrials.gov Identifier: NCT04300816
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : February 4, 2022
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Ivan Molton, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: CBT for Uncertainty Tolerance Behavioral: Traditional CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3- arm randomized clinical trial. Arms: (1) CBT for uncertainty tolerance, (2) traditional CBT, (3) treatment as usual
Masking: None (Open Label)
Masking Description: Research manager will be blinded for this trial. Research coordinator and investigator will not.
Primary Purpose: Supportive Care
Official Title: Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

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 Name: 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 Name: tCBT

No Intervention: TAU
Participant continues with their lives as they normally would.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300816

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Contact: Katie Singsank, BA 206-543-0110 singsank@uw.edu
Contact: Aaron Flaster, BA 206-616-7934 aflaster@uw.edu

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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Katie Singsank, BA    206-543-0110    singsank@uw.edu   
Contact: Aaron Flaster, BA    206-616-7934    aflaster@uw.edu   
Principal Investigator: Ivan Molton, PhD         
Sponsors and Collaborators
University of Washington
National Multiple Sclerosis Society
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Principal Investigator: Ivan Molton, PhD University of Washington
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Responsible Party: Ivan Molton, Professor, School of Medicine: Rehabilitation Medicine: Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT04300816    
Other Study ID Numbers: STUDY00007984
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Data will become available after the main study results are published.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases