Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Intervention to Reduce Distress From Perceived Cognitive Impairment in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889327
• Other study ID #: 17-180
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2020
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 1, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Neuropsychological Feedback & Psychoeducation (Cognition)
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.
• Psychoeducation (Health)
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.

Locations

Country	Name	City	State
United States	University of Kansas Department of Neurology	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	University of Kansas

Country where clinical trial is conducted

United States, 

References & Publications (23)

Akbar N, Honarmand K, Feinstein A. Self-assessment of cognition in Multiple Sclerosis: the role of personality and anxiety. Cogn Behav Neurol. 2011 Sep;24(3):115-21. doi: 10.1097/WNN.0b013e31822a20ae. — View Citation

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. — View Citation

Amato MP, Ponziani G, Rossi F, Liedl CL, Stefanile C, Rossi L. Quality of life in multiple sclerosis: the impact of depression, fatigue and disability. Mult Scler. 2001 Oct;7(5):340-4. — View Citation

Arnett PA, Rao SM, Grafman J, Bernardin L, Luchetta T, Binder JR, Lobeck L. Executive functions in multiple sclerosis: an analysis of temporal ordering, semantic encoding, and planning abilities. Neuropsychology. 1997 Oct;11(4):535-44. — View Citation

Basso MR, Shields IS, Lowery N, Ghormley C, Combs D, Arnett PA, Johnson J. Self-reported executive dysfunction, neuropsychological impairment, and functional outcomes in multiple sclerosis. J Clin Exp Neuropsychol. 2008 Nov;30(8):920-30. doi: 10.1080/13803390801888733. — View Citation

Beier M, Amtmann D, Ehde DM. Beyond depression: Predictors of self-reported cognitive function in adults living with MS. Rehabil Psychol. 2015 Aug;60(3):254-62. doi: 10.1037/rep0000045. Epub 2015 Jul 20. — View Citation

Benedict RH, Cookfair D, Gavett R, Gunther M, Munschauer F, Garg N, Weinstock-Guttman B. Validity of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). J Int Neuropsychol Soc. 2006 Jul;12(4):549-58. — View Citation

Benedict RH. Effects of using same- versus alternate-form memory tests during short-interval repeated assessments in multiple sclerosis. J Int Neuropsychol Soc. 2005 Oct;11(6):727-36. — View Citation

Bruce JM, Bruce AS, Arnett PA. Response variability is associated with self-reported cognitive fatigue in multiple sclerosis. Neuropsychology. 2010 Jan;24(1):77-83. doi: 10.1037/a0015046. — View Citation

Bruce JM, Bruce AS, Hancock L, Lynch S. Self-reported memory problems in multiple sclerosis: influence of psychiatric status and normative dissociative experiences. Arch Clin Neuropsychol. 2010 Feb;25(1):39-48. doi: 10.1093/arclin/acp092. Epub 2009 Dec 3. — View Citation

Carone DA. But the Scores Don't Show How I Really Function: A Feedback Method to Reveal Cognitive Distortions Regarding Normal Neuropsychological Test Performance. Appl Neuropsychol Adult. 2017 Mar-Apr;24(2):160-168. doi: 10.1080/23279095.2015.1116074. Epub 2016 Apr 4. — View Citation

Cull A, Hay C, Love SB, Mackie M, Smets E, Stewart M. What do cancer patients mean when they complain of concentration and memory problems? Br J Cancer. 1996 Nov;74(10):1674-9. — View Citation

Kalmar JH, Gaudino EA, Moore NB, Halper J, Deluca J. The relationship between cognitive deficits and everyday functional activities in multiple sclerosis. Neuropsychology. 2008 Jul;22(4):442-9. doi: 10.1037/0894-4105.22.4.442. — View Citation

Kinsinger SW, Lattie E, Mohr DC. Relationship between depression, fatigue, subjective cognitive impairment, and objective neuropsychological functioning in patients with multiple sclerosis. Neuropsychology. 2010 Sep;24(5):573-80. doi: 10.1037/a0019222. — View Citation

Kujala P, Portin R, Ruutiainen J. The progress of cognitive decline in multiple sclerosis. A controlled 3-year follow-up. Brain. 1997 Feb;120 ( Pt 2):289-97. — View Citation

Maor Y, Olmer L, Mozes B. The relation between objective and subjective impairment in cognitive function among multiple sclerosis patients--the role of depression. Mult Scler. 2001 Apr;7(2):131-5. — View Citation

Middleton LS, Denney DR, Lynch SG, Parmenter B. The relationship between perceived and objective cognitive functioning in multiple sclerosis. Arch Clin Neuropsychol. 2006 Aug;21(5):487-94. Epub 2006 Aug 1. — View Citation

Mittenberg W, Canyock EM, Condit D, Patton C. Treatment of post-concussion syndrome following mild head injury. J Clin Exp Neuropsychol. 2001 Dec;23(6):829-36. Review. — View Citation

Olazarán J, Cruz I, Benito-León J, Morales JM, Duque P, Rivera-Navarro J. Cognitive dysfunction in multiple sclerosis: methods and prevalence from the GEDMA Study. Eur Neurol. 2009;61(2):87-93. doi: 10.1159/000177940. Epub 2008 Nov 28. — View Citation

Rao SM, Leo GJ, Ellington L, Nauertz T, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. II. Impact on employment and social functioning. Neurology. 1991 May;41(5):692-6. — View Citation

Sawrie SM, Marson DC, Boothe AL, Harrell LE. A method for assessing clinically relevant individual cognitive change in older adult populations. J Gerontol B Psychol Sci Soc Sci. 1999 Mar;54(2):P116-24. — View Citation

Sawrie SM, Martin RC, Kuzniecky R, Faught E, Morawetz R, Jamil F, Viikinsalo M, Gilliam F. Subjective versus objective memory change after temporal lobe epilepsy surgery. Neurology. 1999 Oct 22;53(7):1511-7. — View Citation

van Gorp WG, Satz P, Hinkin C, Selnes O, Miller EN, McArthur J, Cohen B, Paz D. Metacognition in HIV-1 seropositive asymptomatic individuals: self-ratings versus objective neuropsychological performance. Multicenter AIDS Cohort Study (MACS). J Clin Exp Neuropsychol. 1991 Sep;13(5):812-9. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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