Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis (MS)

Not Applicable

Completed

• Conditions: Subtopic: Neurological (all Subtopics); Nervous System Diseases; Topic: Neurological disorders; Disease: Multiple Sclerosis

• Registration Number: ISRCTN09697576
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26643818 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31934845 (added 15/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-14
• Study Completion: 2018-08-31
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

1. Are 18 or over and under 70 years of age. The lower age limit is because MS is usually diagnosed in adulthood and treatment strategies tend to be different for children. People aged 70 and over may start to encounter age-related cognitive problems, which may confound the effects of cognitive problem due to MS. Also, most tests are standardised on this adult age group.
2. Have relapsing or progressive MS, diagnosed at least 3 months prior to the baseline assessment contact with the study team, to allow for adjustment to diagnosis. Report having cognitive problems as determined by a cut-off score of >27 on the patient version of the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ). This cut-off is based on previous research and is two standard deviations below the mean for healthy participants.
3. Have cognitive deficits, defined as performance below the 25th percentile on the Brief Repeatable Battery of Neuropsychological Tests (BRBN).
4. Are able to travel to one of the centres and attend group sessions.
5. Are able to speak English sufficiently to complete the cognitive assessments and take part in group sessions.
6. Give informed consent.

Exclusion Criteria

1. Vision or hearing problems, such that they are unable to complete the cognitive assessments, judged by assessor.
2. Have concurrent severe medical or psychiatric conditions which would prevent participants from engaging in treatment, if allocated.
3. Are involved in other psychological intervention trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychological impact of MS; Timepoint(s): 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Memory problems in everyday life; Timepoint(s): 6 and 12 months<br> 2. Mood; Timepoint(s): 6 and 12 months<br> 3. Fatigue; Timepoint(s): 6 and 12 months<br> 4. Carer strain; Timepoint(s): 6 and 12 months<br> 5. Quality of Life; Timepoint(s): 6 and 12 months<br> 6. Attention and memory abilities; Timepoint(s): 6 and 12 months<br> 7. Physical impact of MS; Timepoint(s): 6 and 12 months<br> 8. Cost-effectiveness; Timepoint(s): 6 and 12 months<br> 9. Employment status; Timepoint(s): 6 and 12 months<br> 10. Number of reported relapses in the previous six months; Timepoint(s): 6 and 12 months<br> 11. Disability; Timepoint(s): 6 and 12 months<br>