Memory rehabilitation for people with multiple sclerosis.

BACKGROUND: Problems with cognition, particularly memory, are common in people with multiple sclerosis (MS) and can affect their ability to complete daily activities and can negatively affect quality of life. Over the last few years, there has been considerable growth in the number of randomised controlled trials (RCTs) of memory rehabilitation in MS. To guide clinicians and researchers, this review provides an overview of the effectiveness of memory rehabilitation for people with MS. OBJECTIVES: To determine whether people with MS who received memory rehabilitation compared to those who received no treatment, or an active control showed better immediate, intermediate, or longer-term outcomes in their: 1. memory functions, 2. other cognitive abilities, and 3. functional abilities, in terms of activities of daily living, mood, and quality of life. SEARCH METHODS: We searched CENTRAL which includes Clinicaltrials.gov, World Health Organization (The Whoqol) International Clinical Trials Registry Portal, Embase and PubMed (MEDLINE), and the following electronic databases (6 September 2020): CINAHL, LILACS, the NIHR Clinical Research Network Portfolio database, The Allied and Complementary Medicine Database, PsycINFO, and CAB Abstracts. SELECTION CRITERIA: We selected RCTs or quasi-RCTs of memory rehabilitation or cognitive rehabilitation for people with MS in which a memory rehabilitation treatment group was compared with a control group. Selection was conducted independently first and then confirmed through group discussion. We excluded studies that included participants whose memory deficits were the result of conditions other than MS, unless we could identify a subgroup of participants with MS with separate results. DATA COLLECTION AND ANALYSIS: Eight review authors were involved in this update in terms of study selection, quality assessment, data extraction and manuscript review. We contacted investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with Cochrane methods. We performed a 'best evidence' synthesis based on the methodological quality of the primary studies included. Outcomes were considered separately for 'immediate' (within the first month after completion of intervention), 'intermediate' (one to six months), and 'longer-term' (more than six months) time points. MAIN RESULTS: We added 29 studies during this update, bringing the total to 44 studies, involving 2714 participants. The interventions involved various memory retraining techniques, such as computerised programmes and training on using internal and external memory aids. Control groups varied in format from assessment-only groups, discussion and games, non-specific cognitive retraining, and attention or visuospatial training. The risk of bias amongst the included studies was generally low, but we found eight studies to have high risk of bias related to certain aspects of their methodology. In this abstract, we are only reporting outcomes at the intermediate timepoint (i.e., between one and six months). We found a slight difference between groups for subjective memory (SMD 0.23, 95% CI 0.11 to 0.35; 11 studies; 1045 participants; high-quality evidence) and quality of life (SMD 0.30, 95% CI 0.02 to 0.58; 6 studies; 683 participants; high-quality evidence) favoring the memory rehabilitation group. There was a small difference between groups for verbal memory (SMD 0.25, 95% CI 0.11 to 0.40; 6 studies; 753 participants; low-quality evidence) and information processing (SMD 0.27, 95% CI 0.00 to 0.54; 8 studies; 933 participants; low-quality evidence), favoring the memory rehabilitation group.  We found little to no difference between groups for visual memory (SMD 0.20, 95% CI -0.11 to 0.50; 6 studies; 751 participants; moderate-quality evidence), working memory (SMD 0.16, 95% CI -0.09 to 0.40; 8 studies; 821 participants; moderate-quality evidence), or activities of daily living (SMD 0.06, 95% CI -0.36 to 0.24; 4 studies; 400 participants; high-quality evidence).  AUTHORS' CONCLUSIONS: There is evidence to support the effectiveness of memory rehabilitation on some outcomes assessed in this review at intermediate follow-up. The evidence suggests that memory rehabilitation results in between-group differences favoring the memory rehabilitation group at the intermediate time point for subjective memory, verbal memory, information processing, and quality of life outcomes, suggesting that memory rehabilitation is beneficial and meaningful to people with MS. There are differential effects of memory rehabilitation based on the quality of the trials, with studies of high risk of bias inflating (positive) outcomes. Further robust, large-scale, multi-centre RCTs, with better quality reporting, using ecologically valid outcome assessments (including health economic outcomes) assessed at longer-term time points are still needed to be certain about the effectiveness of memory rehabilitation in people with MS.

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

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.

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 18­69 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.

Evaluation of NeuroPage as a memory aid for people with multiple sclerosis: A randomised controlled trial.

Memory problems are reported in 40%-60% of people with multiple sclerosis (MS). These problems affect independence and may limit the ability to benefit from rehabilitation. Our aim was to evaluate the effectiveness of NeuroPage for people with MS living in the community. A multicentre, single-blind, randomised controlled crossover trial was conducted. The intervention comprised the NeuroPage service, which sends reminder messages to mobile phones at pre-arranged times. In the control condition participants received "non-memory texts", that is, messages not aimed at providing a reminder; for example, supplying news headlines or sport updates. Outcome measures were completed using postal questionnaires after each condition. There were 38 participants aged 28 to 72 (mean 48, SD 11) and 10 (26%) were men. There were no significant differences between NeuroPage and control conditions on the Everyday Memory Questionnaire (p = 0.41, d = 0.02). The number of daily diary items forgotten in the NeuroPage condition was significantly less than in the control (9% vs. 31%, p = 0.01, d = -0.64). Psychological distress was less in the NeuroPage condition than control (p = 0.001, d = -0.84). Further evaluation of the effect on everyday memory is required.

Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS).

OBJECTIVE: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. DESIGN: Multicentre, pragmatic, randomized controlled trial. SETTING: Community. PARTICIPANTS: People with multiple sclerosis aged 18-69 years, who reported cognitive problems in daily life and had cognitive problems on standardized assessment. INTERVENTIONS: A group cognitive rehabilitation programme delivered in 10 weekly sessions in comparison with usual care. MAIN MEASURES: The primary outcome was the Multiple Sclerosis Impact Scale Psychological subscale at 12 months after randomization. Secondary outcomes included measures of everyday memory problems, mood, fatigue, cognitive abilities and employment at 6 and 12 months after randomization. RESULTS: In all, 245 participants were allocated to cognitive rehabilitation and 204 to usual care. Mean Multiple Sclerosis Impact Scale Psychological at 12 months was 22.2 (SD = 6.1) for cognitive rehabilitation and 23.4 (SD = 6.0) for usual care group; adjusted difference -0.6, 95% confidence interval (CI) = -1.5 to 0.3, P = 0.20. No differences were observed in cognitive abilities, fatigue or employment. There were small differences in favour of cognitive rehabilitation for the Multiple Sclerosis Impact Scale Psychological at 6 months and everyday memory and mood at 6 and 12 months. There was no evidence of an effect on costs (-£808; 95% CI = -£2248 to £632) or on quality-adjusted life year gain (0.00; 95% CI = -0.01 to 0.02). CONCLUSION: This rehabilitation programme had no long-term benefits on the impact of multiple sclerosis on quality of life, but there was some evidence of an effect on everyday memory problems and mood.

Experience of Identity Change in People Who Reported a Diagnosis of Multiple Sclerosis: A Qualitative Inquiry.

BACKGROUND: A diagnosis of multiple sclerosis (MS) can lead to changes to a person's sense of self. The aim of this study was to investigate the subjective experience of identity change and subsequent adjustment to MS. METHODS: Semistructured interviews were conducted with 16 people who reported having MS. Interviews were analyzed using thematic analysis. RESULTS: In the early stages of disease progression, participants wanted to compartmentalize the disease. Over time, through reflected self-appraisals, brought about by increasing symptoms and changed relationships with others, the disease became a part of participants' self-identity. CONCLUSIONS: For people with MS, incorporating and accepting the disease as part of their self-identity can have positive implications for seeking and receiving support.

Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT.

BACKGROUND: There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. OBJECTIVE: To evaluate the feasibility of undertaking a definitive trial to evaluate the clinical effectiveness and cost-effectiveness of behavioural activation (BA) compared with usual stroke care for treating post-stroke depression. DESIGN: Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. SETTING: Acute and community stroke services in three sites in England. PARTICIPANTS: Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9 (PHQ-9) or the Visual Analogue Mood Scales 'Sad' item. Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention. RANDOMISATION AND BLINDING: Participants were randomised (1 : 1 ratio) to BA or usual stroke care. Randomisation was conducted using a computer-generated list with random permuted blocks of varying sizes, stratified by site. Participants and therapists were aware of the allocation, but outcome assessors were blind. INTERVENTIONS: The intervention arm received up to 15 sessions of BA over 4 months. BA aims to improve mood by increasing people's level of enjoyable or valued activities. The control arm received usual care only. MAIN OUTCOME MEASURES: Primary feasibility outcomes concerned feasibility of recruitment to the main trial, acceptability of research procedures and measures, appropriateness of baseline and outcome measures, retention of participants and potential value of conducting the definitive trial. Secondary feasibility outcomes concerned the delivery of the intervention. The primary clinical outcome 6 months post randomisation was the PHQ-9. Secondary clinical outcomes were Stroke Aphasic Depression Questionnaire - Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire. RESULTS: Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month. The 25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care. Outcome assessments were completed by 39 (81%) participants (BA, n = 18; usual care, n = 21). Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm. Therapy was delivered as intended. BA was acceptable to participants, carers and therapists. Value-of-information analysis indicates that the benefits of conducting a definitive trial would be likely to outweigh the costs. It is estimated that a sample size of between 580 and 623 participants would be needed for a definitive trial. LIMITATIONS: Target recruitment was not achieved, although we identified methods to improve recruitment. CONCLUSIONS: The Behavioural Activation Therapy for Depression after Stroke trial was feasible with regard to the majority of outcomes. The outstanding issue is whether or not a sufficient number of participants could be recruited within a reasonable time frame for a definitive trial. Future work is required to identify whether or not there are sufficient sites that are able to deliver the services required for a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12715175. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.

Approximately one-third of stroke patients experience depression, which can have negative effects on recovery and quality of life (QoL). Currently, we do not have sufficient evidence to indicate which psychological interventions are effective and affordable to the NHS for treating post-stroke depression. We aimed to determine whether or not it is feasible to conduct a future large-scale study to evaluate a psychological intervention, called behavioural activation (BA) therapy, for treating post-stroke depression. BA aims to improve mood by identifying what stroke patients enjoy doing and helping them to undertake these activities. BA can be used with all stroke patients with depression, including people with cognitive or communication difficulties. We recruited 48 post-stroke patients who had suffered a stroke between 3 months and 5 years previously. People with dementia or significant aphasia were excluded. Participants were divided into two groups at random. About half of the participants received BA over a 4-month period and the other half did not. Participants received all other available care. After 6 months, participants completed questionnaires about their mood, activity level and QoL. We also interviewed 16 participants and 10 carers about their views on the actual research process and therapy. Although we were able to recruit participants to the study, we recruited fewer than the original target of 72 participants owing to delays in starting recruitment. However, we have identified ways to improve participant recruitment in a future study. We found that it was feasible to deliver BA, and the therapy was found to be acceptable to participants, carers and therapists. The results indicate that the benefits of conducting a large-scale future study would outweigh the costs. However, the main consideration will be whether or not we could identify enough stroke services able to run the study for a long enough period to recruit the large number of participants required.

Regaining Confidence after Stroke (RCAS): a feasibility randomised controlled trial (RCT).

BACKGROUND: The Regaining Confidence after Stroke (RCAS) course was designed to facilitate adjustment for people with stroke discharged from rehabilitation. The aim of the trial was to evaluate the feasibility of conducting a randomised trial to compare a RCAS course with usual care. The rates feasibility of screening and recruitment, rates of consent and retention, acceptability of outcome measures and the acceptability and fidelity of the intervention were evaluated. METHODS: Participants with stroke were recruited from hospital databases and community services and randomly assigned to the Regaining Confidence after Stroke (RCAS) course or usual care. The course comprised 11 weekly 2-h sessions with six-eight participants, delivered by two rehabilitation assistants. Carers were invited to attend three of the sessions. Sessions were video recorded. A six-item checklist was developed from the manual content. Each item was rated as met, partially met or not met. Fidelity was assumed if > 75% of the criteria were met. Outcomes were assessed three and six months after randomisation. Semi-structured interviews were conducted using open-ended questions to assess the acceptability of the intervention. RESULTS: Of 47 participants (mean age 66.9 years [SD 14.9]; 26 men), 22 were randomly allocated to the intervention and 25 to usual care. Participants attended a mean of 8.2 [SD 2.6] out of 11 sessions. Fidelity outcomes suggested that the content corresponded to the manual but further training of the therapist was needed. Interview findings indicated the intervention was acceptable and considered beneficial. At three months, 35 (78%) participants returned questionnaires and 30 (67%) at six months, but only 38(42%) were fully completed. CONCLUSION: The results support the feasibility of conducting a randomised trial to evaluate the effectiveness of a RCAS course compared to usual care. TRIAL REGISTRATION: ISRCTN 36330958.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

OBJECTIVE: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING: Community. PARTICIPANTS: People with memory problems following traumatic brain injury, aged 18-69 years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS: A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES: The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12 months post randomization. RESULTS: We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5, p = 0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION: This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.

A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT.

BACKGROUND: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI. DESIGN: Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken. SETTING: Community settings in nine sites in England. PARTICIPANTS: Participants were aged 18-69 years, had undergone a TBI > 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent. RANDOMISATION AND BLINDING: Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded. INTERVENTIONS: In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only. MAIN OUTCOME MEASURES: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire - patient version (EMQ-p) at 6 months' follow-up. Secondary outcomes: Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied. RESULTS: We randomised 328 participants (memory rehabilitation, n = 171; usual care, n = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5; p = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months' follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months' follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be £26.89 cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported. LIMITATIONS: As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the sample. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation. CONCLUSIONS: The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN65792154. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 16. See the NIHR Journals Library website for further project information.

People with brain injuries often report memory problems. These difficulties can continue long after the injury, causing complications in daily life. Many people do not receive specific help for these memory problems after leaving hospital. Our study explored whether receiving 'memory rehabilitation' (a group treatment to help people deal with memory difficulties) was better than the treatment that people usually receive to help reduce the frequency of forgetting in daily life. We recruited 328 people who had memory problems following brain injury. About half were allocated at random to receive memory rehabilitation and half did not have any extra memory treatments, but everyone continued to receive their usual care. Those who had memory rehabilitation were offered 10 group sessions at which strategies were taught to help them cope with memory problems. We asked all participants to complete memory tests and questionnaires at the start of the study and again 6 and 12 months afterwards to find out whether the memory rehabilitation had any effect. Some participants were also interviewed about the study. At the 6- and 12-month assessments, there were no differences between those who received memory rehabilitation and those who did not in terms of how often participants reported memory problems in their daily lives or how well they performed on memory tests. We also did not find any differences in participants' mood or quality of life. However, individual goals set by the participants at the start of the study were a little better met by those who received memory rehabilitation than by those who did not. The memory rehabilitation did not represent value for money. In interviews, participants reported positive experiences of taking part in the study and of attending the group sessions. This group memory rehabilitation programme is unlikely to help people with memory problems following a brain injury more than the usual treatment that people receive. Some people may benefit more from memory rehabilitation than others, but this needs further investigation.

Social Identity in People with Multiple Sclerosis: An Examination of Family Identity and Mood.

BACKGROUND: Mood disorders are highly prevalent in people with multiple sclerosis (MS). MS causes changes to a person's sense of self. The Social Identity Model of Identity Change posits that group membership can have a positive effect on mood during identity change. The family is a social group implicated in adjustment to MS. The objectives of this study were to investigate whether family identity can predict mood in people with MS and to test whether this prediction was mediated by social support and connectedness to others. METHODS: This cross-sectional survey of 195 participants comprised measures of family identity, family social support, connectedness to others, and mood. RESULTS: Family identity predicted mood both directly and indirectly through parallel mediators of family social support and connectedness to others. CONCLUSIONS: Family identity predicted mood as posited by the Social Identity Model of Identity Change. Involving the family in adjustment to MS could reduce low mood.

Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. DESIGN: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. SETTING: Participants' homes or hospital. PARTICIPANTS: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. INTERVENTION: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). MAIN MEASURES: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. RESULTS: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2-8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small ( d = 0.005) to moderate ( d = 0.74), and significant differences in physical function between intervention and usual care groups ( d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. CONCLUSION: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

The Nottingham Fatigue after Stroke (NotFAST) study: factors associated with severity of fatigue in stroke patients without depression.

OBJECTIVE: To identify factors associated with post-stroke fatigue in a sample of stroke survivors without depression. DESIGN: Cross-sectional cohort study. SETTING: Recruitment was from four stroke units in the UK. SUBJECTS: Participants were assessed within four to six weeks of first stroke; those with high levels of depressive symptoms (score ⩾7 Brief Assessment Schedule Depression Cards) were excluded. MAIN MEASURES: Participants were assessed after stroke on the Fatigue Severity Scale of the Fatigue Assessment Inventory, the Rivermead Mobility Index, Nottingham Extended Activities of Daily Living scale, Beck Anxiety Index, Sleep Hygiene Index, 6m walk test, and measures of cognitive ability. RESULTS: Of the 371 participants recruited, 103 were excluded and 268 were assessed. Of the latter, the mean age was 67.7 years (SD 13.5) and 168 (63%) were men. The National Institutes of Health Stroke Scale mean score was 4.96 (SD 4.12). Post-stroke fatigue was reported by 115 (43%) of participants, with 71 (62%) reporting this to be a new symptom since their stroke. Multivariate analysis using the Fatigue Severity Scale as the outcome variable found pre-stroke fatigue, having a spouse/partner, lower Rivermead Mobility Index score, and higher scores on both the Brief Assessment Schedule Depression Cards and Beck Anxiety Index were independently associated with post-stroke fatigue, accounting for approximately 47% of the variance in Fatigue Severity Scale scores. CONCLUSIONS: Pre-stroke fatigue, lower mood, and poorer mobility were associated with post-stroke fatigue.

The Nottingham Fatigue After Stroke (NotFAST) study: results from follow-up six months after stroke.

Background Post-stroke fatigue is common and disabling. Objectives The aim of NotFAST was to examine factors associated with fatigue in stroke survivors without depression, six months after stroke. Methods Participants were recruited from four UK stroke units. Those with high levels of depressive symptoms (score ≥7 on Brief Assessment Schedule Depression Cards) or aphasia were excluded. Follow-up assessment was conducted at six months after stroke. They were assessed on the Fatigue Severity Scale, Rivermead Mobility Index, Nottingham Extended Activities of Daily Living scale, Barthel Index, Beck Anxiety Index, Brief Assessment Schedule Depression Cards, Impact of Event Scale-Revised, and Sleep Hygiene Index. Results Of the 371 participants recruited, 263 (71%) were contacted at six months after stroke and 213 (57%) returned questionnaires. Approximately half (n = 109, 51%) reported fatigue at six months. Of those reporting fatigue initially (n = 88), 61 (69%) continued to report fatigue. 'De novo' (new) fatigue was reported by 48 (38%) of those not fatigued initially. Lower Nottingham Extended Activities of Daily Living scores and higher Beck Anxiety Index scores were independently associated with fatigue at six months. Conclusions Half the stroke survivors reported fatigue at six months post-stroke. Reduced independence in activities of daily living and higher anxiety levels were associated with the level of fatigue. Persistent and delayed onset fatigue may affect independence and participation in rehabilitation, and these findings should be used to inform the development of appropriate interventions.

Using image J to document healing in ulcers of the foot in diabetes.

The aim of the study was to assess the reliability of measuring the cross-sectional area of diabetic foot ulcers using Image J software. The inter- and intra-rater reliability of ulcer area measures were assessed using digital images of acetate tracings of ulcers of the foot affecting 31 participants in an off-loading randomised trial. Observations were made independently by five specialist podiatrists, one of whom was experienced in the use of Image J software and educated the other four in a single session. The mean (±SD) of the mean cross-sectional areas of the 31 ulcers determined independently by the five observers was 1386·7 (±22·7) mm2 . The correlation between all pairs of observers was >0·99 (P < 0·001). There was no significant difference overall between the five observers (ANOVA F1.538; P = 0·165) and no difference between any two (paired samples test t = -0·787-1·396; P ≥ 0·088). The correlation between the areas determined by two observers on two occasions separated by not less than 1 week was very high (0·997 and 0·999; P < 0·001 and <0·001, respectively). The inter- and intra-reliability of the Image J software is very high, with no evidence of a difference either between or within observers. This technique should be considered for both research and clinical use in order to document changes in ulcer area.

Measurement of confidence: the development and psychometric evaluation of a stroke-specific, measure of confidence.

OBJECTIVE: To design, develop and psychometrically evaluate a stroke-specific measure of confidence, the Confidence after Stroke Measure (CaSM). DESIGN: Cross-sectional. SETTING: Adults in the community. PARTICIPANTS: Stroke survivors and healthy elderly participants. METHODS: Questionnaire items were generated based on the literature and qualitative interviews and piloted with expert groups to establish face validity. A 53-item CaSM was administered to stroke survivors and healthy elderly participants in the community. A second copy was posted four weeks later. Completed questionnaires were analysed for extreme responses, missing values, construct validity (factor analysis), convergent validity, divergent validity, reliability (internal consistency and temporal stability) and comparing responses according to age and gender. RESULTS: Stroke ( n = 101) and healthy elderly participants ( n = 101) returned questionnaires. Eight items were removed that had extreme responses and large numbers of missing values. Six items had item total correlations <0.3 and were removed. A further item was removed demonstrating gender difference. An exploratory factor analysis was conducted on the remaining 38 items. A 27-item three factor solution was derived assessing Self-Confidence, Positive Attitude and Social Confidence, which explained 52% of variance. Cronbach's alpha coefficient demonstrated good internal consistency ( α = 0.94). A test re-test on the 27 items indicated good temporal stability ( r = 0.85, P = 0.001). CONCLUSION: The 27-item CaSM was a valid and reliable measure for assessing confidence in stroke survivors.

Evaluation of a group acceptance commitment therapy intervention for people with knee or hip osteoarthritis: a pilot randomized controlled trial.

OBJECTIVES: The aim was to evaluate an Acceptance commitment therapy (ACT) intervention for people with knee or hip osteoarthritis; a related aim was to compare treatment effects from Rasch-transformed and standard scales. METHODS: Participants were recruited from a research database and outpatient rheumatology and orthopaedic clinics at two hospitals. Eligible participants were randomly allocated to either intervention or usual care. Intervention comprised six-sessions of group ACT. Outcomes were assessed two and four months after randomization. Rasch-transformed and standard self-report measures were compared. Qualitative interviews also explored the acceptability of the intervention. RESULTS: Of 87 people assessed for eligibility, 31 (36%) were randomized. The main reason for non-randomization was that participants received surgery. Of the 16 participants randomized to intervention, 64% completed ≥50% of the scheduled group sessions. Follow-up data was complete for 84% participants at two months and 68% at four months. Outcome analysis demonstrated important differences between the Rasch-transformed and standard scales. There were significant differences between the groups in pain. Qualitative interviews with seven participants suggested the intervention was acceptable. CONCLUSIONS: ACT for osteoarthritis is likely to be an acceptable treatment option for people with osteoarthritis. Progress to a definitive trial is warranted. Rasch-transformed outcome scales are preferable in clinical trials where possible. Implications for Rehabilitation Acceptance commitment therapy (ACT) is an effective treatment for many pain conditions andcould be a useful intervention for people with osteoarthritis who have high levels of pain. Rasch analysis is a measurement technique that may enable greater precision in detectingmeaningful treatment effects in routine clinical outcomes. The ACT intervention was successful in reducing pain and sleep difficulties and there werenotable differences in effects between standard and Rasch-transformed scales. In a relatively small trial, ACT may to be an acceptable intervention for people with osteoarthritisand progress to a definitive trial is warranted.

Reliability and responsiveness of measures of pain in people with osteoarthritis of the knee: a psychometric evaluation.

PURPOSE: To examine the fit between data from the Short Form McGill Pain Questionnaire (SF-MPQ-2) and the Rasch model, and to explore the reliability and internal responsiveness of measures of pain in people with knee osteoarthritis. METHODS: Participants with knee osteoarthritis completed the SF-MPQ-2, Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP) and painDETECT. Participants were sent the same questionnaires 3 and 6 months later. RESULTS: Fit to the Rasch model was not achieved for the SF-MPQ-2 Total scale. The Continuous subscale yielded adequate fit statistics after splitting item 10 on uniform DIF for gender, and removing item 9. The Intermittent subscale fit the Rasch model after rescoring items. The Neuropathic subscale had relatively good fit to the model. Test-retest reliability was satisfactory for most scales using both original and Rasch scoring ranging from fair to substantial. Effect sizes ranged from 0.13 to 1.79 indicating good internal responsiveness for most scales. CONCLUSIONS: These findings support the use of ICOAP subscales as reliable and responsive measure of pain in people with knee osteoarthritis. The MPQ-SF-2 subscales found to be acceptable alternatives. Implications for Rehabilitation The McGill Pain Questionnaire short version 2 is not a unidimensional scale in people with knee osteoarthritis, whereas three of the subscales are unidimensional. The McGill Pain Questionnaire short version 2 Affective subscale does not have good measurement properties for people with knee osteoarthritis. The McGill Pain Questionnaire short version 2 and the Intermittent and Constant Osteoarthritis Pain scales can be used to assess change over time. The painDETECT performs better as a screening measure than as an outcome measure.

Behavioural Activation Therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression.

BACKGROUND: There is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression. METHODS/DESIGN: BEADS is a parallel group feasibility multicentre randomised controlled trial with nested qualitative research and economic evaluation. The aim is to evaluate the feasibility of undertaking a full trial comparing behavioural activation (BA) to usual stroke care for 4 months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12 months at three centres, with patients identified from the National Health Service (NHS) community and acute services and from the voluntary sector. They will be randomly allocated to receive behavioural activation in addition to usual care or usual care alone. Outcomes will be measured at 6 months after randomisation for both participants and their carers, to determine their effectiveness. The primary clinical outcome measure for the full trial will be the Patient Health Questionnaire-9 (PHQ-9). Rates of consent, recruitment and follow-up by centre and randomised group will be reported. The acceptability of the intervention to patients, their carers and therapists will also be assessed using qualitative interviews. The economic evaluation will be undertaken from the National Health Service and personal social service perspective, with a supplementary analysis from the societal perspective. A value of information analysis will be completed to identify the areas in which future research will be most valuable. DISCUSSION: The feasibility outcomes from this trial will provide the data needed to inform the design of a definitive multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of behavioural activation for treating post-stroke depression. TRIAL REGISTRATION: Current controlled trials ISRCTN12715175.

Qualitative exploration of the benefits of group-based memory rehabilitation for people with neurological disabilities: implications for rehabilitation delivery and evaluation.

OBJECTIVE: To identify patient-perceived benefits of memory rehabilitation and draw transferrable lessons for the delivery and evaluation of similar interventions for people with neurological disabilities. METHODS: A qualitative study was conducted as part of a pragmatic randomised controlled trial comparing 2 memory rehabilitation approaches with a self-help control group. Postintervention interviews were conducted with 20 participants with a diagnosis of traumatic brain injury, multiple sclerosis or stroke. Data were analysed using a qualitative content analysis approach. RESULTS: Participants receiving memory rehabilitation reported that the sessions responded to previously unmet needs for information on brain injury and memory function and developed their insight along with a sense of self-efficacy and control over the management of their memory problems. Although they did not experience major improvements in their memory function per se, they reported that rehabilitation gave them the skills to effectively cope with the residual deficits. Respondents in the control groups did not report similar benefits. The opportunities for interaction offered by the group setting were greatly valued by all respondents. Mixed aetiology groups were received positively; however, marked differences in cognitive performance were frustrating for some participants. CONCLUSIONS: The study highlighted important patient-perceived outcomes that should be considered by researchers and rehabilitation professionals when evaluating the effects of memory rehabilitation. The use of domain-specific outcome measures which reflect these areas is recommended. Qualitative changes in the use of memory aids may be achieved which cannot be captured by frequency indices alone. The benefits of the group-based rehabilitation approach were stressed by participants, suggesting that a combination of group and individual sessions might be a good practice. TRIAL REGISTRATION NUMBER: ISRCTN92582254; Results.

Cognitive rehabilitation for memory deficits after stroke.

BACKGROUND: Memory problems are a common cognitive complaint following stroke and can potentially affect ability to complete functional activities. Cognitive rehabilitation programmes either attempt to retrain lost or poor memory functions, or teach patients strategies to cope with them.Some studies have reported positive results of cognitive rehabilitation for memory problems, but the results obtained from previous systematic reviews have been less positive and they have reported inconclusive evidence. This is an update of a Cochrane review first published in 2000 and most recently updated in 2007. OBJECTIVES: To determine whether participants who have received cognitive rehabilitation for memory problems following a stroke have better outcomes than those given no treatment or a placebo control.The outcomes of interest were subjective and objective assessments of memory function, functional ability, mood, and quality of life. We considered the immediate and long-term outcomes of memory rehabilitation. SEARCH METHODS: We used a comprehensive electronic search strategy to identify controlled studies indexed in the Cochrane Stroke Group Trials Register (last searched 19 May 2016) and in the Cochrane Central Register of Controlled Trials (CENTRAL2016, Issue 5), MEDLINE (2005 to 7 March 2016), EMBASE 2005 to 7 March 2016), CINAHL (2005 to 5 February 2016), AMED (2005 to 7 March 2016), PsycINFO (2005 to 7 March 2016), and nine other databases and registries. Start dates for the electronic databases coincided with the last search for the previous review. We handsearched reference lists of primary studies meeting the inclusion criteria and review articles to identify further eligible studies. SELECTION CRITERIA: We selected randomised controlled trials in which cognitive rehabilitation for memory problems was compared to a control condition. We included studies where more than 75% of the participants had experienced a stroke, or if separate data were available from those with stroke in mixed aetiology studies. Two review authors independently selected trials for inclusion, which was then confirmed through group discussion. DATA COLLECTION AND ANALYSIS: We assessed study risk of bias and extracted data. We contacted the investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. We performed a 'best evidence' synthesis based on the risk of bias of the primary studies included. Where there were sufficient numbers of similar outcomes, we calculated and reported standardised mean differences (SMD) using meta-analysis. MAIN RESULTS: We included 13 trials involving 514 participants. There was a significant effect of treatment on subjective reports of memory in the short term (standard mean difference (SMD) 0.36, 95% confidence interval (CI) 0.08 to 0.64, P = 0.01, moderate quality of evidence), but not the long term (SMD 0.31, 95% CI -0.02 to 0.64, P = 0.06, low quality of evidence). The SMD for the subjective reports of memory had small to moderate effect sizes.The results do not show any significant effect of memory rehabilitation on performance in objective memory tests, mood, functional abilities, or quality of life.No information was available on adverse events. AUTHORS' CONCLUSIONS: Participants who received cognitive rehabilitation for memory problems following a stroke reported benefits from the intervention on subjective measures of memory in the short term (i.e. the first assessment point after the intervention, which was a minimum of four weeks). This effect was not, however, observed in the longer term (i.e. the second assessment point after the intervention, which was a minimum of three months). There was, therefore, limited evidence to support or refute the effectiveness of memory rehabilitation. The evidence was limited due to the poor quality of reporting in many studies, lack of consistency in the choice of outcome measures, and small sample sizes. There is a need for more robust, well-designed, adequately powered, and better-reported trials of memory rehabilitation using common standardised outcome measures.