Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 For the current study, the investigators will develop a brief computer-based intervention for MS patients who perceive cognitive decline that is incongruent with objective measures of cognitive functioning. The project will accomplish the following specific aims: Develop and assess the feasibility and acceptability of a brief, single-session, computerized intervention (cognitive feedback and psychoeducation; CFP) as part of a randomized controlled pilot trial to reduce perceived cognitive impairment and distress associated with perceived cognitive impairment that is incongruent with objective measures of cognition in MS patients. Examine whether the intervention reduces distress related to perceived cognitive deficits. The investigators hypothesize that patients in the CFP group will report less distress over perceived cognitive impairment compared to the control group immediately after and one week following the intervention. Examine patients understanding of factors that contribute to perceived and objective cognitive impairment in MS. The investigators hypothesize that patients in the CFP group will have an increased understanding of the role that negative emotion, misattribution, and other secondary factors play in the formation of perceived cognitive deficits when compared to patients assigned to the HEH group.

Official Title
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Intervention to Reduce Distress From Perceived Cognitive Impairment in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Neuropsychological Feedback & Psychoeducation (Cognition)
* Behavioral: Psychoeducation (Health)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Once written consent is obtained, patients will complete baseline self-report questionnaires and neuropsychological tests. Immediately following the baseline assessment, patients will be notified of their eligibility. If inclusion criteria is met, patients will be randomized, based on gender in a 2, 4, or 6 block randomization into either the treatment or control group. Patients and the research investigator will be blind to treatment assignment. Participants will complete the intervention and follow-up questionnaires through the research electronic data capture (REDCap), a secure internet-based computerized system. The REDCap link will be emailed to participants within 24 hours of their enrollment into the study. Participants should initiate the intervention at their earliest convenience. The one-week post-intervention follow-up questionnaires will also be emailed directly to participants, and accessed using a REDCap link.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Feedback and Psychoeducation (CFP)<br>Participants assigned to the cognitive feedback and psychoeducation (CFP) treatment group will watch a brief video integrating both neuropsychological test feedback and psychoeducation. The computerized intervention will cover MS disease-related information, define objective cognition, explain neuropsychological assessment, and inform patients of their cognitive test performance outcomes. The CFP intervention will also define and explain perceived cognition and subjective measures of cognition, and compare objective performance on neuropsychological tests to a subjective measure of perceived cognition. The intervention will also discuss emotion, attention, and misattribution related to PCI. The proposed intervention will incorporate expert testimony on MS disease course and related symptomology and interpretations of neuropsychological test performance. | Behavioral: Neuropsychological Feedback & Psychoeducation (Cognition)<br>* The customary practice of providing feedback on neuropsychological test performance can address patient misperceptions of cognitive impairment by distinguishing between perceived and objective neuropsychological test performance. Explaining how normative data is derived by comparison to same age peers, patients are able to better understand their current cognitive functioning. The proposed intervention will employ both psychoeducation and neuropsychological feedback for participants assigned to the treatment group, and psychoeducation for participants assigned to the control group. Both groups will watch 3 brief videos (exactly the same length in time) and answer two qualitative questions following each video.<br>|
| Active Comparator: Healthy Eating Habits (HEH)<br>The control group, healthy eating habits (HEH) group, will watch a brief psychoeducational video of same length in time as the treatment group. The control intervention will include information on importance of healthy eating habits and benefits of a healthy diet including medical outcomes such as reduced blood pressure, and decreased risk of stroke and cardiovascular disease. This intervention will also cover recommended serving sizes for daily helpings of fruits and vegetables, and ways to incorporate fruits and vegetables into meals throughout the day. The proposed control intervention will include expert testimony from a nutritionist and expert dietician. | Behavioral: Psychoeducation (Health)<br>* Information on importance of healthy eating habits and benefits of a healthy diet including medical outcomes such as reduced blood pressure, and decreased risk of stroke and cardiovascular disease. This intervention will also cover recommended serving sizes for daily helpings of fruits and vegetables, and ways to incorporate fruits and vegetables into meals throughout the day. The control intervention will include expert testimony from a nutritionist and expert dietician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Acceptability Questionnaire | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition Quiz | Examine patients understanding of factors that contribute to perceived and objective cognitive impairment in MS. All participants will complete the cognition quiz. Scores range from 0-21, where higher scores indicated greater knowledge of perceived and objective cognition. Within participant analysis will be used to compare changes in score from baseline to immediate post intervention. | 5 minutes | 
| Perceived Cognitive Impairment-Distress (PCI-D) | Examine distress related to perceived cognitive deficits. Within subject comparisons will be made, examining baseline and immediate post intervention responses on this questionnaire. Scores range from 0-60, higher scores indicate greater distress over perceived cognitive deficits. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perceived Cognitive Impairment, Neuropsychology