Coping and Adjusting to Living With Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: CBT for Uncertainty Tolerance
* Behavioral: Traditional CBT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3- arm randomized clinical trial. Arms: (1) CBT for uncertainty tolerance, (2) traditional CBT, (3) treatment as usual
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |