Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis

NCT03889327 | Completed

• 1 other identifier: 17-180
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Perceived Cognitive Impairment; Neuropsychology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cognition Quiz

  5 minutes

• Perceived Cognitive Impairment-Distress (PCI-D)

  5 minutes

Study Arms (2)

Cognitive Feedback and Psychoeducation (CFP)

EXPERIMENTAL

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)

Healthy Eating Habits (HEH)

ACTIVE COMPARATOR

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)

Interventions

Neuropsychological Feedback & Psychoeducation (Cognition) BEHAVIORAL

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.

Cognitive Feedback and Psychoeducation (CFP)

Psychoeducation (Health) BEHAVIORAL

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.

Healthy Eating Habits (HEH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• University of Kansas: collaborator

Study Sites (1)

University of Kansas Department of Neurology

Kansas City, Kansas, 66160, United States

Location

Related Publications (23)

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• Akbar N, Honarmand K, Kou N, Feinstein A. Validity of a computerized version of the symbol digit modalities test in multiple sclerosis. J Neurol. 2011 Mar;258(3):373-9. doi: 10.1007/s00415-010-5760-8. Epub 2010 Oct 6.

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  PMID: 11424633 BACKGROUND

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MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Health

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Jared Bruce, PhD

  UMKC Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2019
• Study Start: March 26, 2018
• Primary Completion: August 15, 2019
• Study Completion: September 1, 2019
• Last Updated: December 6, 2024

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)