Multiple SclerosisNCT03889327
Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis
A study testing Neuropsychological Feedback & Psychoeducation (Cognition) and Psychoeducation (Health) in people with Multiple Sclerosis, run by University of Missouri, Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Neuropsychological Feedback & Psychoeducation (Cognition) and Psychoeducation (Health)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Department of Neurology
Kansas City, Kansas, 66160
About this study
Official title: Intervention to Reduce Distress from Perceived Cognitive Impairment in Multiple Sclerosis
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.
Read the detailed 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:
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Neuropsychological Feedback & Psychoeducation (Cognition), Psychoeducation (Health)
- Keywords
- Perceived Cognitive Impairment, Neuropsychology
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological Feedback & Psychoeducation (Cognition)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation (Health) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start26 Mar 2018
- Primary completion15 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Principal investigator, Jared Bruce, University of Missouri, Kansas City
- Investigators
- Jared Bruce, PhD, Study chair, UMKC Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889327
- Sponsor's protocol ID
- 17-180
- Status last verified
- Nov 2020
- First submitted
- 12 Mar 2018
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1177/135245850100700511.
PubMed 11724451Kujala 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. doi: 10.1093/brain/120.2.289.
PubMed 9117376Beier 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.
PubMed 26192051Benedict 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. doi: 10.1017/s1355617706060723.
PubMed 16981607Olazaran J, Cruz I, Benito-Leon 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.
PubMed 19039226Kinsinger 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.
PubMed 20804245Benedict 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. doi: 10.1017/S1355617705050782.
PubMed 16248908Bruce 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.
PubMed 19959565Kalmar 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.
PubMed 18590356Rao 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. doi: 10.1212/wnl.41.5.692.
PubMed 1823781Basso 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.
PubMed 18608679Middleton 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. doi: 10.1016/j.acn.2006.06.008. Epub 2006 Aug 1.
PubMed 16879944Akbar 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.
PubMed 21904202Akbar 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.
PubMed 20924594Cull 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. doi: 10.1038/bjc.1996.608.
PubMed 8932354
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Distress from Perceived Cognitive Impairment in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03889327
- Acronym / sponsor ID
- 17-180
- Conditions
- Multiple Sclerosis
- Keywords
- Perceived Cognitive Impairment, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Feedback and Psychoeducation (CFP) | Experimental | Behavioral: Neuropsychological Feedback & Psychoeducation (Cognition)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. |
| Healthy Eating Habits (HEH) | Active comparator | Behavioral: Psychoeducation (Health)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Feedback and Psychoeducation (CFP) |
| 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. | Behavioural | Healthy Eating Habits (HEH) |
Primary outcome
Feasibility and Acceptability Questionnaire
Time frame: 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.
2 secondary outcomes
Cognition Quiz
Time frame: 5 minutes
Perceived Cognitive Impairment-Distress (PCI-D)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 11724451Amato 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. doi: 10.1177/135245850100700511.
- Background: PubMed 9117376Kujala 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. doi: 10.1093/brain/120.2.289.
- Background: PubMed 26192051Beier 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.
- Background: PubMed 16981607Benedict 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. doi: 10.1017/s1355617706060723.
- Background: PubMed 19039226Olazaran J, Cruz I, Benito-Leon 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.
- Background: PubMed 20804245Kinsinger 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.
- Background: PubMed 16248908Benedict 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. doi: 10.1017/S1355617705050782.
- Background: PubMed 19959565Bruce 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.
- Background: PubMed 18590356Kalmar 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.
- Background: PubMed 1823781Rao 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. doi: 10.1212/wnl.41.5.692.
- Background: PubMed 18608679Basso 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.
- Background: PubMed 16879944Middleton 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. doi: 10.1016/j.acn.2006.06.008. Epub 2006 Aug 1.
- Individual participant dataSharing planned: No
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Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Bruce, PhD study chair
UMKC Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological Feedback & Psychoeducation (Cognition) and Psychoeducation (Health) in people with Multiple Sclerosis, run by University of Missouri, Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability Questionnaire (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889327, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.