Full text is available at the source.
Health technology assessment (Winchester, England)··
Group cognitive rehabilitation to improve quality of life in people with multiple sclerosis: the CRAMMS clinical trial
Updated
Abstract
Of the 449 participants randomised, 245 were allocated to cognitive rehabilitation.
- There was no clinically important difference in psychological impact scores between cognitive rehabilitation and usual care groups at 12 months.
- Small differences were observed in psychological scores, everyday memory, and mood at 6 and 12 months in favor of the cognitive rehabilitation group.
- No significant differences in cognitive abilities, fatigue, employment, or carer strain were found between the two groups at follow-up.
- Qualitative analysis indicated perceived benefits of cognitive rehabilitation among participants.
- No safety concerns were raised, and no deaths were reported during the trial.
Simplified
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; = 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; = 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. p p
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; Vol. 24, No. 4. See the National Institute for Health Research Journals Library website for further project information. Health Technology Assessment
Related papers
Apr '19
Group memory training program for people with traumatic brain injuries: the ReMemBrIn trial
cited by 9 papers
randomized controlled trial
Mar '19
Goal-focused thinking training for early Alzheimer's and similar dementias: the GREAT trial
cited by 99 papers
randomized controlled trial
Oct '19
Group cognitive-behavioral program to reduce fatigue in rheumatoid arthritis: results from the RAFT trial including cost and experience evaluations
cited by 18 papers
randomized controlled trial
May '20
Longer stroke rehabilitation support for stroke survivors: the EXTRAS clinical trial
cited by 15 papers
randomized controlled trial
Mar '20
Testing a support program for parents with serious personality challenges whose children have mental health issues
cited by 11 papers
randomized controlled trial
May '22
Helping people with early-stage dementia manage their condition and stay independent: the Journeying through Dementia trial
cited by 7 papers
randomized controlled trial