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

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: Jul 23, 2020
• 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/)