跳至主要内容
临床试验/NCT04300816
NCT04300816已完成不适用

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

University of Washington2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2019年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
242
试验地点
2
主要终点
Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Research manager will be blinded for this trial. Research coordinator and investigator will not.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.

时间窗: 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).

时间窗: 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).

时间窗: 6 Months

This is a self-reported measure of perceived anxiety. Greater scores represent greater levels of anxiety.

次要结局

  • Demographic: MS Progression Type. Measured by self-reported type of MS.(Baseline)
  • Demographic: Biological Sex. Measured by self-report.(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Molton

Professor, School of Medicine: Rehabilitation Medicine: Psychology

University of Washington

研究点 (2)

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