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临床试验/NCT03889327
NCT03889327已完成不适用

Intervention to Reduce Distress from Perceived Cognitive Impairment in Multiple Sclerosis

University of Missouri, Kansas City2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年3月26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
51
试验地点
2
主要终点
Feasibility and Acceptability Questionnaire

研究概览

简要总结

Multiple sclerosis (MS) is among the most prevalent autoimmune diseases among young and middle-aged adults. Up to 65% of MS patients experience objective cognitive impairment including problems with information processing speed, memory, and executive functioning. However, patients commonly overestimate the extent of their cognitive dysfunction which can result in inaccurate perceptions of their true cognitive abilities. Exaggerated perceptions of cognitive impairment are predictive of future decline and associated with depression, anxiety, and reduced quality of life. Despite this, no study has examined an intervention aimed at changing misperceptions related to perceived cognitive impairment in MS when objective measures are incongruent with self-reported cognitive symptoms. The purpose of the present study is to develop and pilot a brief intervention for MS patients who perceive cognitive impairment, but perform in the normal or expected range on objective measures of cognition.

详细描述

Concern over worsening cognitive functioning has been shown to significantly impact patients' lives. More than half of all MS patients demonstrate clinically significant cognitive dysfunction, making it one of the leading causes of disability in MS. Cognitive deficits often manifest in areas associated with information processing speed, memory, and executive functioning. Resulting sequela can have profound implications on employment, interpersonal relationships, and activities of daily living. Despite the prevalence of cognitive dysfunction in MS, most studies find little to no relationship between perceived and objective cognition in MS. Research shows that some patients overestimate the extent of their cognitive deficits. PCI is associated with poor self-efficacy, social, and occupational difficulties. Evidence suggests that negative emotional states may contribute to overestimated PCI in MS. Exaggerated perceptions of impaired cognition may be intensified by the presence of other MS symptoms, which can affect the way patients report disease activity to healthcare providers and complicate detection of relevant disease symptomatology.

Overestimating cognitive impairment has been observed in other patient populations, but it is especially problematic in MS and can provide an opportunity to inform patients about discrepancies between perceived and objective cognitive functioning. Since physicians spend significant amounts of time negating unsubstantiated healthcare concerns, an intervention aimed at decreasing PCI in MS may improve long-term healthcare outcomes as well as the quality of time that physicians spend with patients. Neuropsychological test results can be used as objective evidence against perceived cognitive impairment to change patients perceptions, if conveyed in an appropriate and nonthreatening manner.

Educating patients about the influence of emotional dysfunction and misattribution as it relates to PCI may also decrease concern regarding cognitive decline and MS. Specifically, internal processes such as emotional dysfunction, including a globally negative world view can increase dissociative experiences that cause patients to misattribute normal cognitive errors as MS-related cognitive decline. This model may inform patients understanding of medically unsubstantiated PCI, allowing them to consider alternative factors associated with common cognitive errors aside from MS.

Although many studies have aimed to improve cognition in MS through pharmacological treatments, cognitive rehabilitation, and psychotherapy, to the investigators knowledge, this is the first study to examine a psychoeducational intervention to decrease exaggerated perceptions of cognitive impairment in MS. For the present study, the investigators will develop a brief computer-based intervention for MS patients who perceive cognitive decline incongruent with objective measures of cognition. The proposed intervention will incorporate feedback from neuropsychological tests, including comparisons of perceived and objective performance. The intervention will also introduce psychoeducation about causes of PCI, such as emotional distress, attention, and misattribution. It is hoped that by combining neuropsychological test feedback and psychoeducation, patients may better understand differences between perceived and objective cognition, which in turn, may reduce concern and offer alternative explanations for PCI.

Goals and Hypotheses

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

2, 4, and 6 blocked randomization (by gender) was conducted via computer generator. Group assignment was specified and sealed in individual envelopes by a study coordinator who is not involved in the current project. After participants are enrolled and complete the baseline evaluation, the appropriate envelope will be selected, based on gender, containing group assignment, and the subsequent intervention will be administered. Group assignment is not established until after the baseline evaluation has been conducted. Determining randomization will take place at a separate location from the recruitment/baseline site. No study member will have direct contact with participants following the baseline evaluation since the intervention is computerized and replies on emailing the study link to complete the intervention.

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

  • diagnosis of MS by a board-certified neurologist
  • a total score > 40 on the Perceived Deficits Questionnaire (PDQ) based on previous research that identifies this cutoff score as clinically significant in the MS population and two standard deviations below average in the general population (Ruth Ann Marrie, Gordon J. Chelune, Deborah M. Miller, & Jeffrey A. Cohen, 2005)
  • score in the low average or better range on the Wechsler Test of Adult Reading (WTAR)
  • average score equal to or greater than the 16th percentile on the Hopkins Verbal Learning Test (HVLT), Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association Test (COWAT), and Wisconsin Card Sorting Task (WCST)
  • average T score on the HVLT, SDMT, COWAT, and WCST no more than one standard deviation below the WTAR T score
  • access to a computer and a personal email account
  • English-speaking

排除标准

  • no severe sensory, motor, physical, or neurological impairment that would make participation in the study insurmountable
  • no history of nervous system disorder other than MS

结局指标

主要结局

Feasibility and Acceptability Questionnaire

时间窗: 5 minutes

All participants complete a feasibility and acceptability questionnaire upon study completion. The questionnaire will address satisfaction with study participation, effectiveness and convenience of the intervention, and short answer questions on newly acquired information, application of information learned, and feelings about the new information. Participants will also be asked if they perceived the intervention as helpful and if they would be willing to recommend it to other MS patients. This measure will be scored quantitatively, ranging from 0-85 possible points, where higher scores indicated greater feasibility and acceptability of the intervention.

次要结局

  • Cognition Quiz(5 minutes)
  • Perceived Cognitive Impairment-Distress (PCI-D)(5 minutes)

研究者

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

Jared Bruce

Professor

University of Missouri, Kansas City

研究点 (2)

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