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Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT.
Health Technol Assess. 2020 01; 24(4):1-182.HT

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.

Authors+Show Affiliations

Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.School of Health Sciences, University of Nottingham, Nottingham, UK.Swansea Centre for Health Economics, Swansea University, Swansea, UK.Swansea Centre for Health Economics, Swansea University, Swansea, UK.Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.Institute of Mental Health, Nottingham, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31934845

Citation

Lincoln, Nadina B., et al. "Group Cognitive Rehabilitation to Reduce the Psychological Impact of Multiple Sclerosis On Quality of Life: the CRAMMS RCT." Health Technology Assessment (Winchester, England), vol. 24, no. 4, 2020, pp. 1-182.
Lincoln NB, Bradshaw LE, Constantinescu CS, et al. Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT. Health Technol Assess. 2020;24(4):1-182.
Lincoln, N. B., Bradshaw, L. E., Constantinescu, C. S., Day, F., Drummond, A. E., Fitzsimmons, D., Harris, S., Montgomery, A. A., & das Nair, R. (2020). Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT. Health Technology Assessment (Winchester, England), 24(4), 1-182. https://doi.org/10.3310/hta24040
Lincoln NB, et al. Group Cognitive Rehabilitation to Reduce the Psychological Impact of Multiple Sclerosis On Quality of Life: the CRAMMS RCT. Health Technol Assess. 2020;24(4):1-182. PubMed PMID: 31934845.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT. AU - Lincoln,Nadina B, AU - Bradshaw,Lucy E, AU - Constantinescu,Cris S, AU - Day,Florence, AU - Drummond,Avril Er, AU - Fitzsimmons,Deborah, AU - Harris,Shaun, AU - Montgomery,Alan A, AU - das Nair,Roshan, PY - 2020/1/15/entrez PY - 2020/1/15/pubmed PY - 2021/4/23/medline KW - COGNITION KW - COGNITIVE REHABILITATION KW - COST-EFFECTIVENESS ANALYSIS KW - MEMORY KW - MEMORY PROBLEMS KW - MEMORY REHABILITATION KW - MULTIPLE SCLEROSIS SP - 1 EP - 182 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 24 IS - 4 N2 - 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. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/31934845/Group_cognitive_rehabilitation_to_reduce_the_psychological_impact_of_multiple_sclerosis_on_quality_of_life:_the_CRAMMS_RCT_ L2 - https://doi.org/10.3310/hta24040 DB - PRIME DP - Unbound Medicine ER -