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Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

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.

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.

BackgroundPeople 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.ObjectiveTo assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI.DesignMulticentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken.SettingCommunity settings in nine sites in England.ParticipantsParticipants 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 blindingClusters 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.InterventionsIn 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 measuresOutcomes 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.ResultsWe 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.LimitationsAs 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.ConclusionsThe 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 registrationCurrent Controlled Trials ISRCTN65792154.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 16. See the NIHR Journals Library website for further project information.

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.

BackgroundIf effective, less intensive treatments for people with personality disorder have the potential to serve more people.ObjectivesTo compare the clinical effectiveness and cost-effectiveness of psychoeducation with problem-solving (PEPS) therapy plus usual treatment against usual treatment alone in improving social problem-solving with adults with personality disorder.DesignMultisite two-arm, parallel-group, pragmatic randomised controlled superiority trial.SettingCommunity mental health services in three NHS trusts in England and Wales.ParticipantsCommunity-dwelling adults with any personality disorder recruited from community mental health services.InterventionsUp to four individual sessions of psychoeducation, a collaborative dialogue about personality disorder, followed by 12 group sessions of problem-solving therapy to help participants learn a process for solving interpersonal problems.Main outcome measuresThe primary outcome was measured by the Social Functioning Questionnaire (SFQ). Secondary outcomes were service use (general practitioner records), mood (measured via the Hospital Anxiety and Depression Scale) and client-specified three main problems rated by severity. We studied the mechanism of change using the Social Problem-Solving Inventory. Costs were identified using the Client Service Receipt Inventory and quality of life was identified by the European Quality of Life-5 Dimensions questionnaire. Research assistants blinded to treatment allocation collected follow-up information.ResultsThere were 739 people referred for the trial and 444 were eligible. More adverse events in the PEPS arm led to a halt to recruitment after 306 people were randomised (90% of planned sample size); 154 participants received PEPS and 152 received usual treatment. The mean age was 38 years and 67% were women. Follow-up at 72 weeks after randomisation was completed for 62% of participants in the usual-treatment arm and 73% in the PEPS arm. Intention-to-treat analyses compared individuals as randomised, regardless of treatment received or availability of 72-week follow-up SFQ data. Median attendance at psychoeducation sessions was approximately 90% and for problem-solving sessions was approximately 50%. PEPS therapy plus usual treatment was no more effective than usual treatment alone for the primary outcome [adjusted difference in means for SFQ –0.73 points, 95% confidence interval (CI) –1.83 to 0.38 points;p = 0.19], any of the secondary outcomes or social problem-solving. Over the follow-up, PEPS costs were, on average, £182 less than for usual treatment. It also resulted in 0.0148 more quality-adjusted life-years. Neither difference was statistically significant. At the National Institute for Health and Care Excellence thresholds, the intervention had a 64% likelihood of being the more cost-effective option. More adverse events, mainly incidents of self-harm, occurred in the PEPS arm, but the difference was not significant (adjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.64).LimitationsThere was possible bias in adverse event recording because of dependence on self-disclosure or reporting by the clinical team. Non-completion of problem-solving sessions and non-standardisation of usual treatment were limitations.ConclusionsWe found no evidence to support the use of PEPS therapy alongside standard care for improving social functioning of adults with personality disorder living in the community.Future workWe aim to investigate adverse events by accessing centrally held NHS data on deaths and hospitalisation for all PEPS trial participants.Trial registrationCurrent Controlled Trials ISRCTN70660936.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 52. See the NIHR Journals Library website for further project information.