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Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT

Lincoln, Nadina B.; Bradshaw, Lucy E.; Constantinescu, Cris S.; Day, Florence; Drummond, Avril E.R.; Fitzsimmons, Deborah; Harris, Shaun; Montgomery, Alan A.; das Nair, Roshan; CRAMMS Trial Collaborative Group

Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT Thumbnail


Authors

Nadina B. Lincoln

Cris S. Constantinescu

Florence Day

AVRIL DRUMMOND avril.drummond@nottingham.ac.uk
Professor of Healthcare Research

Deborah Fitzsimmons

Shaun Harris

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

ROSHAN NAIR Roshan.dasnair@nottingham.ac.uk
Professor of Clinical Psychology and Neuropsychology

CRAMMS Trial Collaborative Group



Abstract

Abstract
Background
People with multiple sclerosis have problems with memory and attention. The effectiveness of cognitive rehabilitation has not been established.

Objectives
The objectives were to assess the clinical effectiveness and cost-effectiveness of a cognitive rehabilitation programme for people with multiple sclerosis.

Design
This was a multicentre, randomised controlled trial in which participants were randomised in a ratio of 6 : 5 to receive cognitive rehabilitation plus usual care or usual care alone. Participants were assessed at 6 and 12 months after randomisation.

Setting
The trial was set in hospital neurology clinics and community services.

Participants
Participants were people with multiple sclerosis who had cognitive problems, were aged 18–69 years, could travel to attend group sessions and gave informed consent.

Intervention
The intervention was a group cognitive rehabilitation programme delivered weekly by an assistant psychologist to between four and six participants for 10 weeks.

Main outcome measures
The primary outcome was the Multiple Sclerosis Impact Scale – Psychological subscale at 12 months. Secondary outcomes included results from the Everyday Memory Questionnaire, the 30-Item General Health Questionnaire, the EuroQol-5 Dimensions, five-level version and a service use questionnaire from participants, and the Everyday Memory Questionnaire – relative version and the Modified Carer Strain Index from a relative or friend of the participant.

Results
Of the 449 participants randomised, 245 were allocated to cognitive rehabilitation (intervention group) and 204 were allocated to usual care (control group). Of these, 214 in the intervention group and 173 in the control group were included in the primary analysis. There was no clinically important difference in the Multiple Sclerosis Impact Scale – Psychological subscale score between the two groups at the 12-month follow-up (adjusted difference in means –0.6, 95% confidence interval –1.5 to 0.3; p = 0.20). There were no important differences between the groups in relation to cognitive abilities, fatigue, employment, or carer strain at follow-up. However, there were differences, although small, between the groups in the Multiple Sclerosis Impact Scale – Psychological subscale score at 6 months (adjusted difference in means –0.9, 95% confidence interval –1.7 to –0.1; p = 0.03) and in everyday memory on the Everyday Memory Questionnaire as reported by participants at 6 (adjusted difference in means –5.3, 95% confidence interval –8.7 to –1.9) and 12 months (adjusted difference in means –4.4, 95% confidence interval –7.8 to –0.9) and by relatives at 6 (adjusted difference in means –5.4, 95% confidence interval –9.1 to –1.7) and 12 months (adjusted difference in means –5.5, 95% confidence interval –9.6 to –1.5) in favour of the cognitive rehabilitation group. There were also differences in mood on the 30-Item General Health Questionnaire at 6 (adjusted difference in means –3.4, 95% confidence interval –5.9 to –0.8) and 12 months (adjusted difference in means –3.4, 95% confidence interval –6.2 to –0.6) in favour of the cognitive rehabilitation group. A qualitative analysis indicated perceived benefits of the intervention. There was no evidence of a difference in costs (adjusted difference in means –£574.93, 95% confidence interval –£1878.93 to £729.07) or quality-adjusted life-year gain (adjusted difference in means 0.00, 95% confidence interval –0.02 to 0.02). No safety concerns were raised and no deaths were reported.

Citation

Lincoln, N. B., Bradshaw, L. E., Constantinescu, C. S., Day, F., Drummond, A. E., Fitzsimmons, D., …CRAMMS Trial Collaborative Group. (2020). Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT. Health Technology Assessment, 24(4), 1-182. https://doi.org/10.3310/hta24040

Journal Article Type Article
Acceptance Date Feb 28, 2019
Online Publication Date Jan 14, 2020
Publication Date Jan 14, 2020
Deposit Date Jul 22, 2020
Publicly Available Date Mar 29, 2024
Journal Health Technology Assessment
Print ISSN 1366-5278
Electronic ISSN 2046-4924
Publisher NIHR Journals Library
Peer Reviewed Peer Reviewed
Volume 24
Issue 4
Pages 1-182
DOI https://doi.org/10.3310/hta24040
Public URL https://nottingham-repository.worktribe.com/output/3753223
Publisher URL https://www.journalslibrary.nihr.ac.uk/hta/hta24040#/abstract
Additional Information Contractual start date: 9-2014; Editorial review begun: 9-2018; Accepted for publication: 2-2019.

Published version Available under Non-Commercial government licence for public sector information (http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/)