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Randomized Controlled Trial
. 2020 Jan;24(4):1-182.
doi: 10.3310/hta24040.

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

Nadina B Lincoln  1 , Lucy E Bradshaw  2 , Cris S Constantinescu  3 , Florence Day  2 , Avril Er Drummond  4 , Deborah Fitzsimmons  5 , Shaun Harris  5 , Alan A Montgomery  2 , Roshan das Nair  6
Affiliations
Randomized Controlled Trial

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

Nadina B Lincoln et al. Health Technol Assess. 2020 Jan.

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.

Limitations: The trial included a sample of participants who had relatively severe cognitive problems in daily life. The trial was not powered to perform subgroup analyses. Participants could not be blinded to treatment allocation.

Conclusions: This cognitive rehabilitation programme had no long-term benefits on quality of life for people with multiple sclerosis.

Future work: Future research should evaluate the selection of those who may benefit from cognitive rehabilitation.

Trial registration: Current Controlled Trials ISRCTN09697576.

Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 4. See the National Institute for Health Research Journals Library website for further project information.

Keywords: COGNITION; COGNITIVE REHABILITATION; COST-EFFECTIVENESS ANALYSIS; MEMORY; MEMORY PROBLEMS; MEMORY REHABILITATION; MULTIPLE SCLEROSIS.

Plain language summary

Cognitive (or mental processing) problems, particularly those affecting memory and attention, are common in people with multiple sclerosis. Multiple sclerosis is a condition that affects the brain and causes nerve damage. Cognitive rehabilitation can involve: retraining cognitive skills, which are the core skills your brain uses to think, read, learn, remember, reason and concentrateteaching strategies to cope in daily life. Cognitive rehabilitation is rarely provided for people with multiple sclerosis. A trial was carried out to determine whether or not providing a group cognitive rehabilitation programme improved quality of life more than usual clinical care, which did not involve any cognitive rehabilitation. The effects on daily memory problems, mood, fatigue and employment were examined and also the cost-effectiveness of the treatment. A total of 449 people with multiple sclerosis took part in the trial. They all agreed to be part of the research trial, had cognitive problems, were aged 18–69 years and could travel to attend group sessions. Participants were then allocated to receive cognitive rehabilitation or not, on the basis of chance (i.e. randomly). All participants were followed up for 1 year. Although both groups showed no differences in quality of life after 1 year, those who received cognitive rehabilitation had fewer memory problems in daily life and reported better mood than those who received only their usual clinical care. There were no differences in their levels of fatigue or disability, or in employment status. The qualitative results indicated that participants found the intervention useful. Treatment cost slightly less than usual care but had modest benefits. Overall, the results suggest that there may be modest short-term benefits of cognitive rehabilitation, and future studies will consider how such benefits can be maintained and whether or not some people benefit more than others.

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Conflict of interest statement

Alan A Montgomery reports grants from the National Institute for Health Research (NIHR) and membership of the NIHR Health Technology Assessment (HTA) Clinical Evaluation and Trials Funding Board during the conduct of the study. Roshan das Nair reports membership of the NIHR Health Services and Delivery Research Board, the HTA End of Life Care and Add-on Studies Board and the NIHR Research for Patient Benefit (East Midlands), and personal fees from Biogen Inc. (Cambridge, MA, USA). Avril ER Drummond reports membership of the NIHR Clinical Lectureships panel. Cris S Constantinescu reports grants, personal fees and other from Bayer AG (Leverkusen, Germany); Biogen Inc.; Merck, Sharp & Dohme (Kenilworth, NJ, USA); Novartis International AG (Basel, Switzerland), Sanofi Genzyme (Cambridge, MA, USA) and Teva Pharmaceuticals Industries Ltd (Petah Tikva, Israel). He also reports grants and personal fees from GW Pharmaceuticals (Cambridge, UK), Morphosys (Planegg, Germany), Roche (Basel, Switzerland); and grants from Sanofi-Pasteur-MSD (Lyon, France), outside the submitted work.

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