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

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.

The impact of cognitive rehabilitation on quality of life in multiple sclerosis: A pilot study

“…Prior studies have used quality of life measures as their primary outcome measure with mixed results. [7][8][9][10] Notably these studies used group cognitive rehabilitation sessions rather than individual therapy sessions. The authors noted a need for additional studies to see if the benefit identified in some of the studies was due to the supportive group setting rather than any cognitive retraining or adaptation.…”

Focus on neglected features of cognitive rehabilitation in MS: Setting and mode of the treatment

“…The beneficial effect on mood could be explained considering that participants in the intervention group were less distressed by their memory problems as a result of the memory rehabilitation or due to the social interaction in a group mode. 33 In a multicenter study, Lincoln et al 55 assessed the clinical effectiveness and cost-effectiveness of a CR program for PwMS compared to a usual care intervention. Although both groups showed no differences in quality of life after one year, those who received CR had fewer memory problems in daily life and reported better mood than those who received only their usual clinical care.…”

“…In a multicenter study, Lincoln et al 55 assessed the clinical effectiveness and cost-effectiveness of a CR program for PwMS compared to a usual care intervention. Although both groups showed no differences in quality of life after one year, those who received CR had fewer memory problems in daily life and reported better mood than those who received only their usual clinical care.…”

Occupational Therapy Interventions in Adults with Multiple Sclerosis or Amyotrophic Lateral Sclerosis: A Scoping Review

“…In nonpharmacological treatment, there are specific interventions aimed at physical rehabilitation such as electro-stimulation or Proprioceptive Neuromuscular Facilitation (PNF) [ 15 ]; there are also interventions to maintain daily life skills and others aimed at psychological or cognitive rehabilitation with the participation of occupational therapist [ 11 , 13 ]. Regarding cognitive intervention, Lincoln et al, carried out a comparative study based on attention and memory which resulted in an improvement in memory and lifestyle in the experimental group compared to the control group [ 16 ].…”

“…In nonpharmacologi-cal treatment, there are specific interventions aimed at physical rehabilitation such as electro-stimulation or Proprioceptive Neuromuscular Facilitation (PNF) [15]; there are also interventions to maintain daily life skills and others aimed at psychological or cognitive rehabilitation with the participation of occupational therapist [11,13]. Regarding cognitive intervention, Lincoln et al, carried out a comparative study based on attention and memory which resulted in an improvement in memory and lifestyle in the experimental group compared to the control group [16]. Some previous occupational therapy studies have proposed psychosocial promotion interventions [17,18] such as the Community Reintegration for Socially Isolated Patients (CRISP) occupation-based intervention, which used education and self-management strategies in MS patients, performing socializing and recreation activities to improve self-efficacy and to reduce perceptions of loneliness [18].…”