Cognitive Rehabilitation for Attention and Memory in people with Multi

Cognitive Rehabilitation for Attention and Memory for people with Multiple Sclerosis (CRAMMS): a pragmatic randomised controlled trial

Completed (inferred)Not a drug-phase studyProgressive MSISRCTN09697576

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • Psychological impact of MS; Timepoint(s): 12 months

Other measures (1)

  • 1. Memory problems in everyday life; Timepoint(s): 6 and 12 months 2. Mood; Timepoint(s): 6 and 12 months 3. Fatigue; Timepoint(s): 6 and 12 months 4. Carer strain; Timepoint(s): 6 and 12 months 5. Quality of Life; Timepoint(s): 6 and 12 months 6. Attention and memory abilities; Timepoint(s): 6 and 12 months 7. Physical impact of MS; Timepoint(s): 6 and 12 months 8. Cost-effectiveness; Timepoint(s

    RelapsesThinking and memoryFatigueMood and sleepQuality of life (reported by participants)

Who could take part

Progressive MS · 18 and over

Show the full criteria

Inclusion criteria

Inclusion: 1. Are 18 or over and under 70 years of age. The lower age limit is because MS is usually diagnosed in adulthood and treatment strategies tend to be different for children. People aged 70 and over may start to encounter age-related cognitive problems, which may confound the effects of cognitive problem due to MS. Also, most tests are standardised on this adult age group. 2. Have relapsing or progressive MS, diagnosed at least 3 months prior to the baseline assessment contact with the study team, to allow for adjustment to diagnosis. Report having cognitive problems as determined by a cut-off score of >27 on the patient version of the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ). This cut-off is based on previous research and is two standard deviations below the mean for healthy participants. 3. Have cognitive deficits, defined as performance below the 25th percentile on the Brief Repeatable Battery of Neuropsychological Tests (BRBN). 4. Are able to travel to one of the centres and attend group sessions. 5. Are able to speak English sufficiently to complete the cognitive assessments and take part in group sessions. 6. Give informed consent. Exclusion: 1. Vision or hearing problems, such that they are unable to complete the cognitive assessments, judged by assessor. 2. Have concurrent severe medical or psychiatric conditions which would prevent participants from engaging in treatment, if allocated. 3. Are involved in other psychological intervention trials.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Many people with multiple sclerosis (MS) experience problems with attention, concentration and memory. They may be offered advice on how to cope with these problems. Cognitive rehabilitation is a structured approach to deal with these problems. The aim of this study is to compare group cognitive rehabilitation programme with usual care. We will look at the usefulness of the rehabilitation in reducing memory and attention problems and what it would cost to deliver this programme in the NHS. Who can participate? Adults aged 18-70 years with MS. What does the study involve? Participants will be in the study on average 16 months from consent to end of follow-up. There will be an initial assessment to find out whether the participant fulfils all the criteria to take part in the study. The second visit will record baseline details and the participant’s availability to attend group sessions. When enough participants have been enrolled, each participant will be randomly allocated to receive either group cognitive rehabilitation sessions plus usual care or usual care only. Participants allocated to the usual care group will not have to do anything else until their 6 month follow-up appointment. Participants allocated to the cognitive rehabilitation group will be invited to attend 10 therapy sessions lasting about 1.5 hours, which will take place over about 10 weeks and are led by an assistant psychologist. All participants will have follow-up visits at 6 and 12 months. These will include assessments and completion of questionnaires. What are the possible benefits and risks of participating? We do not know whether taking part in the study will help but we expect that some people will find the intervention helps them cope with memory and attention problems. However, the information we get from this study may help us to treat people with MS and attention and memory problems better in future. There are no particular risks involved in taking part in this study. Where is the study run from? Four centres in the UK, based in Nottingham, Sheffield, Liverpool and Birmingham. Updated 22/06/2017: Five centres in the UK, based in Nottingham, Sheffield, Liverpool, Bristol and South Tees. When is the study starting and how long is it expected to run for? The study starts in September 2014 and is expected to run until August 2018. Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Prof Nadina Lincoln cramms@nottingham.ac.uk

Papers

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History

    1. Started

      Sept 2014

    2. Finished

      Aug 2018

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