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Coping and Adjusting to Living With Multiple Sclerosis (CALMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT for Uncertainty Tolerance
Traditional CBT
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

CBT-UT

tCBT

TAU

Arm Description

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

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

Participant continues with their lives as they normally would.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
Demographic: Biological Sex. Measured by self-report.
This is a self-reported demographic question. Options include: Male, Female, Transgender, and If not listed explain.

Full Information

First Posted
March 4, 2020
Last Updated
June 21, 2023
Sponsor
University of Washington
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT04300816
Brief Title
Coping and Adjusting to Living With Multiple Sclerosis
Acronym
CALMS
Official Title
Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3- arm randomized clinical trial. Arms: (1) CBT for uncertainty tolerance, (2) traditional CBT, (3) treatment as usual
Masking
Outcomes Assessor
Masking Description
Research manager will be blinded for this trial. Research coordinator and investigator will not.
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-UT
Arm Type
Experimental
Arm Description
Seven telephone-based sessions of cognitive behavioral therapy for uncertainty tolerance (CBT-UT) delivered over seven weeks.
Arm Title
tCBT
Arm Type
Active Comparator
Arm Description
Seven telephone-based sessions of traditional cognitive behavioral therapy (tCBT) delivered over seven weeks.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Participant continues with their lives as they normally would.
Intervention Type
Behavioral
Intervention Name(s)
CBT for Uncertainty Tolerance
Other Intervention Name(s)
CBT-UT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional CBT
Other Intervention Name(s)
tCBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.
Description
This is a self-reported measure of perceived MS Acceptance. Greater scores represent greater MS Acceptance.
Time Frame
6 Months
Title
Questionnaire: Level of anxiety as measured by the Global Anxiety Disorder-7 scale (GAD-7).
Description
This is a self-reported measure of perceived anxiety. Greater scores represent greater levels of anxiety.
Time Frame
6 Months
Title
Questionnaire: Level of depression as measured by the Patient Health Questionnaire (PHQ-9).
Description
This is a self-reported measure of perceived depression. Greater scores represent greater levels of depression.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Demographic: MS Progression Type. Measured by self-reported type of MS.
Description
This is a self-reported demographic question. Options include: Relapsing-Remitting, Primary-Progressive, Secondary-Progressive, Progressive-Relapsing, and Don't Know.
Time Frame
Baseline
Title
Demographic: Biological Sex. Measured by self-report.
Description
This is a self-reported demographic question. Options include: Male, Female, Transgender, and If not listed explain.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Molton, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Coping and Adjusting to Living With Multiple Sclerosis

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