Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University of Washington
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ivan Molton
Professor, School of Medicine: Rehabilitation Medicine: Psychology
University of Washington
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.
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Demographic: MS Progression Type. Measured by self-reported type of MS.(Baseline)
- Demographic: Biological Sex. Measured by self-report.(Baseline)