Clinical trial NCT04300816: Coping and Adjusting to Living With Multiple Sclerosis
Official title: Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2020-03-09
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3- arm randomized clinical trial. Arms: (1) CBT for uncertainty tolerance, (2) traditional CBT, (3) treatment as usual
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.
timeFrame: 6 Months
measure: Questionnaire: Level of anxiety as measured by the Global Anxiety Disorder-7 scale (GAD-7).
timeFrame: 6 Months
measure: Questionnaire: Level of depression as measured by the Patient Health Questionnaire (PHQ-9).
timeFrame: 6 Months
Secondary outcomes:
measure: Demographic: MS Progression Type. Measured by self-reported type of MS.
timeFrame: Baseline
measure: Demographic: Biological Sex. Measured by self-report.
timeFrame: Baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ivan Molton, PhD
role: PRINCIPAL_INVESTIGATOR
References: