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Purpose To determine changes to people’s social contact during COVID-19, and whether reduced social contact was associated with changes to psychosocial wellbeing. Methods Questionnaire data were collected from a sample of adult respondents (18 years or more) in two Norwegian counties participating pre-COVID-19 (September 2019–February 2020; n = 20,196) and at two time points during COVID-19 (June [Mid] and November/December [Late] 2020; n = 11,953 and n = 10,968, respectively). The main outcome measures were participants' self-reported changes to social contact, loneliness, psychological distress, and life satisfaction. Results The proportion of respondents reporting less social contact due to COVID-19 decreased from 62% in Mid-2020 to 55% in Late-2020. Overall, reported psychological wellbeing remained unchanged or improved from pre-COVID-19 to Mid-2020. From Mid-2020 to Late-2020, however, a reduction in psychological wellbeing was observed. Poorer psychological wellbeing was found for those with less social contact during the pandemic compared with people reporting unchanged social contact. This effect increased over time and was observed for all age groups at Late-2020. At Mid-2020, the importance of change in social contact for change in psychological wellbeing was greatest among young adults ( Conclusion The association between COVID-19-era changes to social contact and loneliness, psychological distress, and life satisfaction is complex and appears to be age-dependent. Future studies should consider the quality of social contact and cultural contexts in which social restrictions are imposed.

BACKGROUND: Supporting people with multiple sclerosis (MS) at work can be challenging due to the unpredictable nature and myriad of disease-related symptoms, and issues related to the work environment. OBJECTIVE: To explore, amongst people with MS in employment, their experiences of and need for vocational rehabilitation (VR), and perceived barriers and facilitators to implementing VR. METHODS: We conducted 20 semi-structured interviews with people with MS, employers, and healthcare professionals. Interviews were audio-recorded, transcribed, and analysed using the framework method. RESULTS: We identified nine themes reflecting the main MS symptoms (e.g. cognition, fatigue), and environmental factors such as support provided at work (e.g. change of working hours) and workplace characteristics. Providing support tailored to the individual’s needs and early intervention were seen as important attributes for the intervention. The barriers identified referred to lack of resources and confidentiality issues; however, having flexibility in the content and delivery of the intervention were seen as facilitators. CONCLUSION: The impact of environmental factors (e.g. attitudes towards disability) on employment difficulties is equal to or greater than disease-related factors. Environmental changes in the attitudes of co-workers and workplace flexibility can enable people with MS to remain in work for longer.

Background: The accurate evaluation of valued living in people with acquired brain injury (ABI) is important for measuring the outcome of interventions targeting valued living. The Valued Living Questionnaire (VLQ) is one of the most widely used measures, however its validity in an ABI cohort may be affected by the cognitive demands associated with evaluating the value-consistency of actions in the past week. Objectives: We aimed to systematically identify common difficulties or errors associated with the comprehension and completion of the VLQ in people with ABI in order to guide a potential adaptation of the measure. Methods: Adults with an ABI (traumatic brain injury, stroke, tumour), experiencing cognitive difficulties and/or emotional distress impacting participation in valued activities, were invited to participate in a cognitive interview which probed their understanding of the VLQ. Concurrent verbal probing was used, whereby scripted verbal probes were asked alongside each questionnaire item as it was being rated by participants. Interviews were transcribed and analysed by combining data pertaining to each item and aggregating these across interviews to highlight common comprehension errors or difficulties. Results: There were 11 participants (mean age = 59.55 years, SD = 12.84; mean education = 14.73 years, SD = 2.87) with a range of ABI aetiologies (7 stroke, 2 TBI, 2 tumour). Common difficulties with the VLQ included confusion caused by question phrasing and structure of the measure, errors due to the cognitive demands associated with rating the importance of abstract values and value-consistency of actions in the last week, and problems with the rating scale. Conclusions: Key problems with the validity of the VLQ within an ABI sample were identified due to comprehension errors relating to its structure and content. Findings will inform an adapted version, suited to the needs of individuals with ABI-associated cognitive difficulties.

BackgroundThe PRomoting Activity, Independence and Stability in Early Dementia (PrAISED) study delivered an exercise and functional activity programme to participants living with dementia. A Randomised Controlled Trial (RCT) showed no measurable benefits in activities of daily living, physical activity or quality of life.ObjectiveTo explore participants’ responses to PrAISED and explain the mechanisms behind a complex intervention that did not lead to expected health gains.MethodsA process evaluation using qualitative methods, comprising interviews and researcher notesSettingData were collected in participants’ homes or remotely by telephone or videoconferencing.SampleEighty-eight interviews were conducted with 44 participants living with dementia (n = 32 intervention group; n = 12 control group) and 39 caregivers. Sixty-nine interviews were conducted with 26 therapists.ResultsParticipants valued the intervention as proactively addressing health issues that were of concern to them, and as sources of social contact, interaction, information, and advice. Facilitators to achieving positive outcomes included perceiving progress toward desired goals, positive expectations, therapists’ skills and rapport with participants, and caregiver support. Barriers included: cognitive impairment, which prevented independent engagement and carryover between sessions; chronic physical health problems and intercurrent acute illness and injury; ‘tapering’ (progressively infrequent supervision intended to help develop habits and independent activity); and the COVID-19 pandemic.ConclusionsInterventions aiming to maintain activity, independence and stability may not be appropriate in the context of dementia even in the mild stages of the condition. Various factors affected outcomes including caregiver support, rapport with therapists, availability of supervision, motivational factors, and the limitations of remote delivery. The effects of cognitive impairment, multimorbidity and frailty overwhelmed any positive impact of the intervention. Maintenance of functional ability is valued, but in the face of inevitable progression of disease, other less tangible outcomes become important, challenging how we frame ‘health gain’ and trial outcomes.

BackgroundDementia is associated with frailty leading to increased risks of falls and hospitalisations. Interventions are required to maintain functional ability, strength and balance.DesignMulti-centre parallel group randomised controlled trial, with embedded process evaluation. Procedures were adapted during the COVID-19 pandemic.ParticipantsPeople with mild dementia or mild cognitive impairment (MCI), living at home, and a family member or carer.ObjectivesTo determine the effectiveness of an exercise and functional activity therapy intervention compared to usual care.InterventionA specially-designed dementia-specific rehabilitation programme focussing on strength, balance, physical activity and performance of ADL, which was tailored, progressive, addressed risk and the psychological and learning needs of people with dementia, providing up to 50 therapy sessions over 12 months. The control group received usual care plus a falls risk assessment.Main outcome measureThe primary outcome was the informant-reported Disability Assessment for Dementia (DAD) 12 months after randomisation. Secondary outcomes were: self-reported ADL, cognition, physical activity, quality of life, frailty, balance, functional mobility, fear of falling, mood, carer strain and service use (at 12 months) and falls (between months 4 and 15).Results365 people were randomised, 183 to intervention and 182 to control. Median age of participants was 80 years (range 65-95), median Montreal Cognitive Assessment score 20/30 (range 13-26), 58% were men. Participants received a median of 31 (IQR = 22-40) therapy sessions out of a possible maximum of 50. Participants reported completing a mean 121 minutes/week of PrAISED activity outside of supervised sessions. Primary outcome data were available for 149 (intervention) and 141 (control) participants. There was no difference in DAD scores between groups: adjusted mean difference -1.3/100, 95% Confidence Interval (−5.2 to +2.6); Cohen’s d effect size -0.06 (−0.26 to +0.15); p=0.5. Upper 95% confidence intervals excluded small to moderate effects on any of the range of secondary outcome measures. Between months 4 and 15 there were 79 falls in the intervention group and 200 falls in the control group, adjusted incidence rate ratio 0.78 (0.5 to 1.3); p= 0.3.ConclusionThe intensive PrAISED programme of exercise and functional activity training did not improve ADLs, physical activity, quality of life, reduce falls or improve any other secondary health status outcomes even though uptake was good. Future research should consider alternative approaches to risk reduction and ability maintenance.Trial registrationISRCTN15320670.FundingNational Institute for Health and Care ResearchWhat is already knownDementia is associated with progressive loss of functional ability, including activities of daily living and mobility, and a high risk of fallsExercise programmes and rehabilitation therapies may improve ability, or slow the rate of decline, but evidence from trials and systematic reviews is equivocalWhat this study tells usWe developed an intensive dementia-specific exercise and functional activity rehabilitation programme, lasting 12 months, taking account of motivation, learning needs and context, in particular the need to engage carers, and evaluated it in a randomised controlled trialThe programme was very well received by participants and therapists, but had no effect on activities of daily living, physical activity, quality of life, falls, cognition or any other health status outcomeWe are unlikely to be able to change rate of loss of ability in dementia through exercise or functionally orientated rehabilitation therapy.We need different ways of defining wellbeing after a dementia diagnosis.

Introduction Individuals with acquired brain injury may find it difficult to self-manage and live independently. Brain-in-Hand is a smartphone app designed to support psychological problems and encourage behaviour change, comprised of a structured diary, reminders, agreed solutions, and traffic light monitoring system. Aim To evaluate the potential use and effectiveness of Brain-in-Hand for self-management in adults with acquired brain injury. Methods A-B mixed-methods case-study design. Individuals with acquired brain injury ( n = 10) received Brain-in-Hand for up to 12 months. Measures of mood, independence, quality of life, cognition, fatigue, goal attainment, participation administered at baseline, 6 and 12 months. Semi-structured interviews conducted with acquired brain injury participants ( n = 9) and healthcare workers ( n = 3) at 6 months. Results Significant increase in goal attainment after 6 months use (t(7) = 4.20, p = .004). No significant improvement in other outcomes. Qualitative data suggested improvement in anxiety management. Contextual (personal/environmental) factors were key in influencing the use and effectiveness of Brain-in-Hand. Having sufficient insight, appropriate support and motivation facilitated use. Conclusions Brain-in-Hand shows potential to support acquired brain injury, but further work is required to determine its effectiveness. Context played a pivotal role in the effectiveness and sustained use of Brain-in-Hand, and needs to be explored to support implementation.

Adjustment to life with acquired brain injury (ABI) requires self-identity and behaviour to be updated, incorporating injury-related changes. Identifying and enabling new values-consistent behaviours could facilitate this process. We evaluated the feasibility, acceptability, and preliminary efficacy of VaLiANT, a new group intervention that aims to enhance "valued living" following ABI. We used a non-concurrent multiple baseline single-case experimental design (SCED) with an 8-week follow-up phase and randomization to multiple baseline lengths (5-7 weeks). Eight participants (50% women, aged 26-65; 4 Stroke, 3 Traumatic Brain Injury, 1 Epilepsy) attended eight group sessions with assessments before, during, and after the group. Target behaviour was valued living, assessed weekly by the Valued Living Questionnaire. Secondary outcomes included measures of wellbeing, mood, psychological acceptance, self-efficacy regarding ABI consequences, cognitive complaints, and intervention acceptability. Target behaviour was analysed through visual and statistical analysis while secondary outcome data were analysed via reliable change indices and descriptive statistics. Target behaviour data displayed no convincing patterns of improvement. Reliable improvements were found for most participants on secondary outcomes, particularly subjective wellbeing and anxiety. Intervention delivery was feasible with high acceptability ratings. Further investigation of VaLiANT is warranted, based on the feasibility and acceptability of intervention delivery and signals of efficacy identified across adjustment-related secondary outcomes.

Introduction Transitioning to secondary progressive multiple sclerosis (SPMS) is a difficult time for people, fraught with uncertainty and an increase in physical disability. In parallel, healthcare appointments become less frequent, most disease modifying treatments are withdrawn, and social contacts typically become more difficult to maintain. The aim of this study was to assess whether providing a brief, Acceptance and Commitment Therapy (ACT)–based telephone support intervention during transition to SPMS is feasible, effective and valued by participants. Method A single centre, mixed-methods, two-arm feasibility randomised controlled trial (RCT), comparing (i) ACT-based support + treatment as usual to (ii) treatment as usual only, was conducted for those who had transitioned to SPMS. Feasibility, signal of efficacy and acceptability were assessed in both groups by self-report measures at 3 timepoints (baseline, 8 weeks, 12 weeks), and feedback interviews analysed using framework analysis following the completion of the study. Results The recruitment strategy was not feasible: 14 of 40 were recruited (35%) during the four-month time period (Mage = 53, 10 women). The data collection procedures and trial processes were feasible and acceptable to participants, reflected through all measures being completed, no attrition, and positive participant interview feedback. The intervention did not demonstrate a signal of efficacy between baseline and 8-week or 12-week follow up on measures, but wide confidence intervals preclude drawing strong conclusions. Positive interview feedback suggested outcomes not being captured through self-report measures. Discussion Due to an unsuccessful recruitment strategy and mixed evidence of efficacy, certain adjustments should be made to the intervention and methodology before progressing to a definitive trial. A more efficient recruitment strategy, or longer recruitment period is needed to recruit a large enough sample. Adaptations to the ACT intervention may be needed to ensure that it targets psychological flexibility, which could include changing the workbook or session delivery based on interview feedback, however the small sample size means we should interpret the efficacy findings with caution.

Cognitive problems are common in people with Multiple Sclerosis (MS), and researchers and clinicians have used a vast array of measures to assess cognition. Our aim was to systematically identify cognitive measures routinely used in MS research, and outline their different uses. Previous recommendations of cognitive measures to use in MS have relied on expert consensus approaches. We believe this systematic review is a starting point for an evidence-based approach to recommend cognitive tests for use with people with MS. We systematically searched electronic databases using relevant search terms for studies that assessed cognitive functioning in MS (last search in February 2020). From 11,854 abstracts retrieved, based on title and abstract review, 2563 remained. Data were extracted from 1526 studies. Studies used 5665 measures of cognition, with 316,053 people with MS. Substitutional style tests, serial addition tests, and word list learning tests were the most commonly used individual tests, and the Brief Repeatable Battery of Neuropsychological Tests was the most commonly used battery. Some of the most frequently used measures were potentially inappropriate due to measuring irrelevant domains of cognition, and issues with sensitivity. Further research is needed to ascertain the psychometric properties, and acceptability of measures for people with MS.

There is a growing consensus that cognitive assessments should form part of routine clinical care in Multiple Sclerosis (MS). However, what remains unclear is which assessments are preferred by “stakeholders” (including people with MS, family members, charity volunteers, clinicians, and healthcare commissioners), in which contexts, and in which formats. Therefore, the aim of this study was to collect and synthesize stakeholders’ perceptions of the assessments that are acceptable and feasible for routine administration in the UK healthcare system. We interviewed 44 stakeholders and held one focus group (n = 5). We asked stakeholders about their experience with cognitive impairment and assessment and their views on how cognitive assessment could be implemented within routine clinical care. Using framework analysis, we summarized three themes: the current cognitive screening situation; the suitability of commonly used assessments; and feasibility aspects, including modality and location of testing. All participants acknowledged that cognitive impairment could have a significant impact on the quality of life, but that assessment and monitoring are not routinely performed in clinics. Barriers and enablers were described, and most participants reported that brief, routine screening with tests such as symbol substitution was acceptable. Electronic, self-administration of cognitive screening would be beneficial in minimizing clinic attendance and staff time.

One of the strongest predictors of successful coping in multiple sclerosis (MS) is the extent to which one can accept the diagnosis and limitations associated with the disease. Acceptance is also one of three core processes of psychological flexibility - a malleable treatment target of some psychological therapies. This is the ability to notice and accept the presence of thoughts and feelings without being swept along by them, engaging in the present moment, and making decisions in line with personal values. Poor psychological flexibility is associated with elevated levels of distress in the general population. However, we do not know the level of psychological flexibility in people with MS, or its relationship to distress or quality of life when the disease becomes more physically disabling. The aims of this study were to determine the level of psychological flexibility, and its relationship with distress and quality of life in secondary progressive multiple sclerosis (SPMS), a subtype of MS with increased severity of disability and distress.This cross-sectional analytic study used data collected by the UK MS Register. Pre-existing data on distress, quality of life, disability, and demographics collected by the UK MS Register were combined with a psychological flexibility measure and its component parts, collected for the purpose of this study. Patient demographics and questionnaire data were recorded for distress, quality of life, and psychological flexibility. Pearson's correlations were used to examine bivariate relationships between distress, quality of life, disability and psychological flexibility. Whether psychological flexibility moderated the relationship between disability (predictor), distress and quality of life (outcomes) was also investigated.Between February and March 2020, 628 participants with SPMS completed the CompACT and had a recent (12 months) HADS questionnaire (MGreater psychological flexibility was associated with lower self-reported distress and higher quality of life in this SPMS sample. It was not shown to moderate the extent to which physical disability predicts distress or quality of life in SPMS. These findings demonstrate that greater psychological flexibility is related to better coping outcomes (lower distress, higher quality of life) in SPMS. If psychological flexibility can be increased in people with SPMS, this could lead to a reduction in distress and improvement in quality of life, although directionality could not be attributed with these methods. Further longitudinal evidence and trials of psychological flexibility-focussed interventions are needed.

Objective To establish the effectiveness of relaxation and related therapies in treating Multiple Sclerosis related symptoms and sequelae. Data Sources PsycINFO, PubMed, Embase, CINAHL, ProQuest Dissertations and Theses Global databases were searched. Methods We included studies from database inception until 31 December 2021 involving adult participants diagnosed with multiple sclerosis or disseminated sclerosis, which featured quantitative data regarding the impact of relaxation interventions on multiple sclerosis-related symptoms and sequelae. Studies which examined multi-modal therapies - relaxation delivered in combination with non-relaxation interventions - were excluded. Risk of bias was assessed using the Revised Risk of Bias tool for randomised trials – ROB2, Risk of Bias in Non-Randomised Studies of Interventions ROBINS-I), and within and between-group effects were calculated (Hedges’ g). Results Twenty-eight studies met inclusion criteria. Twenty-three of these were randomised controlled trials, with 1246 total participants. This review reports on this data, with non-randomised study data reported in supplemental material. Post –intervention relaxation was associated with medium to large effect-size improvement for depression, anxiety, stress and fatigue. The effects of relaxation were superior to wait-list or no treatment control conditions; however, comparisons with established psychological or physical therapies were mixed. Individual studies reported sustained effects (≤ 6 months) with relaxation for stress, pain and quality of life. Most studies were rated as having a high/serious risk of bias. Conclusion There is emerging evidence that relaxation therapies can improve outcomes for persons with multiple sclerosis. Given the high risk of bias found for included studies, stronger conclusions cannot be drawn.

ObjectivesThis study aimed to: (1) understand the context for delivering a trauma vocational rehabilitation (VR) intervention; (2) identify potential barriers and enablers to the implementation of a VR intervention post-trauma.DesignQualitative study. Data were collected in person or via phone using different methods: 38 semistructured interviews, 11 informal ‘walk-through care pathways’ interviews, 5 focus groups (n=25), 5 codesign workshops (n=43). Data were thematically analysed using the framework approach, informed by the Consolidated Framework for Implementation Research.SettingStakeholders recruited across five UK major trauma networks.ParticipantsA variety of stakeholders were recruited (n=117) including trauma survivors, rehabilitation physicians, therapists, psychologists, trauma coordinators and general practitioners. We recruited 32 service users (trauma survivors or carers) and 85 service providers.ResultsThere were several issues associated with implementing a trauma VR intervention including: culture within healthcare/employing organisations; extent to which healthcare systems were networked with other organisations; poor transition between different organisations; failure to recognise VR as a priority; external policies and funding. Some barriers were typical implementation issues (eg, funding, policies, openness to change). This study further highlighted the challenges associated with implementing a complex intervention like VR (eg, inadequate networking/communication, poor service provision, perceived VR priority). Our intervention was developed to overcome these barriers through adapting a therapist training package, and by providing early contact with patient/employer, a psychological component alongside occupational therapy, case coordination/central point of contact, and support crossing sector boundaries (eg, between health/employment/welfare).ConclusionsFindings informed the implementation of our VR intervention within the complex trauma pathway. Although we understand how to embed it within this context, the success of its implementation needs to be measured as part of a process evaluation in a future trial.

Background: This is an update of the Cochrane review ‘Memory rehabilitation for people with multiple sclerosis’ (first published in the Cochrane Library 14 March 2012, Issue 3). Impairments in cognitive function, particularly memory, are common in people with multiple sclerosis (MS) and can potentially affect their ability to complete functional activities. There is evidence from single-case or small group studies that memory rehabilitation can be beneficial for people with MS, but findings from randomised controlled trials (RCTs) and systematic reviews have been inconclusive. Objectives: To determine whether people with MS who received memory rehabilitation showed: 1. better outcomes in their memory functions compared to those given no treatment or receiving a placebo control; and 2. better functional abilities, in terms of activities of daily living, mood, and quality of life, than those who received no treatment or a placebo. Search methods: We searched the Trials Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group (2 June 2015) and the following electronic databases: The NIHR Clinical Research Network Portfolio database (NIHR CRN) (from 2010 to June 2015), The Allied and Complementary Medicine Database (AMED) (2010 to June 2015), British Nursing Index (BNI) (2010 to June 2015), PsycINFO (2011 to June 2015), and CAB Abstracts (2010 to June 2015). Start dates for the electronic databases coincided with the last search for the previous review. We handsearched relevant journals and reference lists. Selection criteria: We selected RCTs or quasi-randomised trials ofmemory rehabilitation or cognitive rehabilitation for people with MS in which a memory rehabilitation treatment group was compared to 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: Three review authors were involved in this update in terms of study selection, quality assessment, and data extraction. We contacted investigators of primary studies for further information where required. We conducted data analysis and synthesis in accordance with the Cochrane Handbook for Systematic Reviews ofInterventions (Higgins 2011). We performed a ’best evidence’ synthesis based on the methodological quality of the primary studies included. Main results: We added seven studies during this update, bringing the total to 15 studies, involving 989 participants. The interventions involved various memory retraining techniques, such as computerised programmes and training on 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 of the included studies was generally low, but we found eight studies to have high risk of bias related to certain aspects of their methodology. We found significant effect of intervention on objective assessments of memory in both the immediate and long-term follow-ups: standardised mean difference (SMD) 0.23 (95% confidence interval (CI) 0.05 to 0.41) and SMD 0.26 (95% CI 0.03 to 0.49), respectively. We also found significant effect of intervention for quality of life in the immediate follow-up (SMD 0.23 (95% CI 0.05 to 0.41)). These findings showed that the intervention group performed significantly better than the control group. We also found a significant difference for activities of daily living (ADL) in the long-term follow-up (SMD -0.33 (95% CI -0.63 to -0.03)), showing that the control groups had significantly less difficulty completing ADLs than the intervention groups. We found no significant effects, either immediate or long-term, on subjective reports of memory problems (SMD 0.04 (95% CI -0.19 to 0.27) and SMD 0.04 (95% CI -0.19 to 0.27)); on mood (SMD 0.02 (95% CI -0.16 to 0.20) and SMD -0.01 (95% CI -0.21 to 0.20)); and on immediate follow-up for ADL (SMD -0.13 (95% CI -0.60 to 0.33)) and in the long term for quality of life (SMD 0.16 (95% CI -0.03 to 0.36)). We could not complete a sensitivity analysis of intention-to-treat in comparison with per-protocol analysis, due to insufficient information from the included papers. However, a sensitivity analysis of high- versus low-risk studies suggested that while quality of the trials did not affect most outcomes, differences were seen in the objective memory outcomes (both at immediate and long term) and quality of life (immediate) outcome, with studies with higher risk of bias inflating the overall effect size estimates for these outcomes, and the test of overall effect changing from being statistically significant to not significant when studies at high risk of bias were excluded. This suggests that lower-quality studies may have positively influenced the outcomes. Authors’ conclusions: There is some evidence to support the effectiveness of memory rehabilitation on memory function, as well as on quality of life. However, the evidence is limited and does not extend to subjective reports of memory functioning or mood. Furthermore, the objective measures used are not ecologically valid measures, and thus potentially limit generalisability of these findings into daily life. Further robust RCTs of high methodological quality and better quality of reporting, using ecologically valid outcome assessments, are still needed.

CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Delaware Media Group. The CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Credit The CMSC designates this journal-based activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Credit The CMSC designates this enduring material for 1.0 contact hour (none in the area of pharmacology). Disclosures: Editor in Chief of the International Journal of MS Care (IJMSC), has served as physician planner for this activity. He has disclosed relationships with Springer Publishing (royalty); Qr8 (receipt of intellectual property rights/patent holder); Abide Therapeutics, GW Pharma (consulting fee); Biogen (speakers' bureau); and Adamas Pharmaceuticals (contracted research).Francois Bethoux, MD, has served as reviewer for this activity. She has disclosed no relevant financial relationships.Laurie Scudder, DNP, NP, has disclosed no relevant financial relationships.Alexander B. Barker, PhD, has disclosed no relevant financial relationships.Kathryn Smale, PhD, has disclosed no relevant financial relationships.Nigel Hunt, PhD, has disclosed no relevant financial relationships.Nadina B. Lincoln, PhD, has disclosed a relationship with Biogen and Novartis (speakers' bureau).Roshan das Nair, PhD, The peer reviewers for IJMSC have disclosed no relevant financial relationships. The staff at IJMSC, CMSC, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Financial relationships for some authors may have changed in the interval between listing these disclosures and publication of the article. Method of Participation: Release Date: October 1, 2019 Valid for Credit Through: October 1, 2020 In order to receive CME/CNE credit, participants must: Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

Rehabilitation is an essential aspect of symptomatic and supportive treatment for people with multiple sclerosis (MS). The number of randomised controlled trials (RCTs) for rehabilitation interventions in MS has increased over the last two decades. The design, conduct and reporting quality of some of these trials could be improved. There are, however, some specific challenges that researchers face in conducting RCTs of rehabilitation interventions, which are often ‘complex interventions’. This paper explores some of the challenges of undertaking robust clinical trials in rehabilitation. We focus on issues related to (1) participant selection and sample size, (2) interventions – the ‘dose’, content, active ingredients, targeting, fidelity of delivery and treatment adherence, (3) control groups and (4) outcomes – choosing the right type, number, timing of outcomes, and the importance of defining a primary outcome and clinically important difference between groups. We believe that by following internationally accepted RCT guidelines, by developing a critical mass of MS rehabilitation ‘trialists’ through international collaboration and by continuing to critique, challenge, and develop RCT designs, we can exploit the potential of RCTs to answer important questions related to the effectiveness of rehabilitation interventions.

Tobacco smoking is a well-established risk factor for multiple sclerosis (MS) onset, progression and poor health outcomes in people with MS. Despite smoking being a modifiable risk factor, no research has been undertaken to understand how, or who is best placed, to assess or understand smoking behaviour in people with MS, or how healthcare professionals can best assist people with MS to quit. People with MS may have unique motivators to continue smoking, or unique barriers to smoking cessation, that are not addressed by existing cessation tools. Research is urgently needed in this area if the aim is to maximise health outcomes for all people with MS.

IntroductionCognitive problems are common after stroke and their identification and management is important for survivors, carers and clinicians. However, the appropriateness of the screening metho...

ObjectivesTo capture the complexities and unique experience of a newly formed multidisciplinary and multicentre research team developing and deploying a COVID-19 study and to identify lessons learnt.DesignCo-autoethnographic study.SettingStaff at two UK academic institutions, a national charity and two major UK hospitals.ParticipantsResearchers, clinicians, academics, statisticians and analysts, patient and public involvement representatives and national charity.MethodsThe sampling frame was any content discussed or shared between research team members (emails, meeting minutes, etc), standard observational dimensions and reflective interviews with team members. Data were thematically analysed.ResultsData from 34 meetings and >50 emails between 17 March and 5 August 2020 were analysed. The analysis yielded seven themes with ‘Managing our stress’ as an overarching theme.ConclusionsMutual respect, flexibility and genuine belief that team members are doing the best they can under the circumstances are essential for completing a time-consuming study, requiring a rapid response during a pandemic. Acknowledging and managing stress and a shared purpose can moderate many barriers, such as the lack of face-to-face interactions, leading to effective team working.

BackgroundInfections can trigger exacerbations of multiple sclerosis (MS). The effects of the coronavirus disease 2019 (COVID-19) on MS are not known. The aim of this study was to understand the impact of COVID-19 on new and pre-existing symptoms of MS.MethodsThe COVID-19 and MS study is an ongoing community-based, prospective cohort study conducted as part of the United Kingdom MS Register. People with MS and COVID-19 were invited by email to complete a questionnaire about their MS symptoms during the infection. An MS exacerbation was defined as developing new MS symptoms and/or worsening of pre-existing MS symptoms.ResultsFifty-seven percent (230/404) of participants had an MS exacerbation during their infection; 82 developed new MS symptoms, 207 experienced worsened pre-existing MS symptoms, and 59 reported both. Disease modifying therapies (DMTs) reduced the likelihood of developing new MS symptoms during the infection (OR 0.556, 95%CI 0.316-0.978). Participants with a higher pre-COVID-19 webEDSS (web-based Expanded Disability Status Scale) score (OR 1.251, 95%CI 1.060-1.478) and longer MS duration (OR 1.042, 95%CI 1.009-1.076) were more likely to experience worsening of their pre-existing MS symptoms during the infection.ConclusionCOVID-19 infection was associated with exacerbation of MS. DMTs reduced the chance of developing new MS symptoms during the infection.

Background Traumatic injuries are common amongst working-age adults. Survivors often experience physical and psychological problems, reduced quality of life and difficulty returning to work. Vocational rehabilitation improves work outcomes for a range of conditions but evidence of effectiveness for those with traumatic injuries is lacking. This study assesses feasibility of delivering a vocational rehabilitation intervention to enhance return to work and improve quality of life and wellbeing in people with at least moderate trauma to inform design of a definitive randomised controlled trial (RCT). Methods Non-randomised, single-arm, multi-centre mixed-methods feasibility study with nested case studies and qualitative study. The case studies comprise interviews, observations of clinical contacts and review of clinical records. The qualitative study comprises interviews and/or focus groups. Participants will be recruited from two UK major trauma centres. Participants will comprise 40 patients aged 16–69 with an injury severity score of > 8 who will receive the intervention and complete questionnaires. Interviews will be conducted with 10 patients and their occupational therapists (OTs), clinical psychologists (CPs), employers and commissioners of rehabilitation services. Fidelity will be assessed in up to six patients by observations of OT and CP—patient contacts, review of patient records and intervention case report forms. OT and CP training will be evaluated using questionnaires and competence to deliver the intervention assessed using a team objective structured clinical examination and written task. Patients participating in and those declining participation in the study will be invited to take part in interviews/focus groups to explore barriers and facilitators to recruitment and retention. Outcomes include recruitment and retention rates, intervention fidelity, OT and CP competence to deliver the intervention, experiences of delivering or receiving the intervention and factors likely to influence definitive trial delivery. Discussion Effective vocational rehabilitation interventions to enhance return to work amongst trauma patients are urgently needed because return to work is often delayed, with detrimental effects on health, financial stability, healthcare resource use and wider society. This protocol describes a feasibility study delivering a complex intervention to enhance return to work in those with at least moderate trauma. Trial registration ISRCTN: 74668529. Prospectively registered on 23 January 20

Introduction Smoking is a key modifiable risk factor for health outcomes of people with multiple sclerosis (MS). Little evidence exists on whether the information and support needs of people with MS who smoke are met. This study aimed to explore knowledge, attitudes and beliefs about smoking and quitting, and quitting support needs in Australian people with MS. Methods Current and recent smokers were recruited for phone interviews through social media and newsletters. Interview data were analysed in NVivo using framework analysis. Results We interviewed 25 people with MS (20 current and five recent smokers). Many participants had little knowledge about the risks of smoking on MS progression. Some reported perceived benefits from smoking on MS symptoms, while others perceived smoking worsening their symptoms. Similarly, quitting was believed to have health benefits, but concerns about withdrawal symptoms and the impact on MS symptoms and relapses were common. Participants reported ambivalence discussing smoking with clinicians; some wanting more information and support, while also feeling shame or guilt. Many participants were asked about their smoking status by MS clinicians, however, the provision of evidence-based information, and referrals to quitting support services was very infrequent. General practitioners were often found helpful and supportive, but participants gave more weight to quit advice from MS clinicians. Conclusion Our results are the first to indicate that smoking cessation needs of Australian people with MS are not met. These findings should be confirmed in a larger sample, but there is potential to investigate whether implementing routine provision of brief advice in MS care, as a coordinated effort between MS researchers, practitioners, consumer advocates and behavioural intervention services, may meet these needs. Further, developing targeted resources and training quit counsellors to provide appropriate information and support specific to people with MS may improve smoking cessation success in people with MS.

Highlights • No established care pathway exists for screening and managing cognitive problems. • Based on stakeholder interviews, we developed a logic model for the pathway. • The logic model illustrates how a new clinical care pathway could work. • To work, the pathway relies on shared responsibility and a person-centred approach., Background: Cognitive problems are a common and debilitating symptom of multiple sclerosis (MS). Screening and treatment for cognitive problems are recommended, however these are not routinely delivered in UK clinics. We collected and synthesised stakeholder perspectives to develop a care pathway for cognitive problems in MS and produce a logic model, illustrating how this pathway might operate. Methods: Forty-nine stakeholders, including people with MS and care providers, participated in semi-structured interviews and focus groups. Participants viewed information that illustrated how the pathway might work and provided feedback. Data, transcribed verbatim and analysed using Framework Analysis, were mapped onto a preliminary logic model and accompanying thematic framework. Results: The proposed pathway was perceived as helpful in providing standardised support for a neglected MS symptom. Training packages, online cognitive screening, and triaging decisions were viewed as crucial activities. Shared responsibility, a person-centred approach, and addressing the complexity of cognitive problems were important engagement mechanisms. Allocating time during clinic appointments and within staff workloads were essential resources for implementation. Conclusion: Our co-constructed MS cognitive screening and management pathway will be evaluated for clinical and cost-effectiveness in a trial. However, in the interim, clinicians can adapt and implement this pathway in their own services and evaluate it locally.

Three decades ago a series of parallel circuits were described involving the frontal cortex and deep grey matter structures, with putative roles in control of motor and oculomotor function, cognition, behaviour and emotion. The circuit comprising the dorsolateral prefrontal cortex, caudate, globus pallidus and thalamus has a putative role in regulating executive functions. The aim of this study is to investigate effective connectivity (EC) of the dorsolateral‐prefrontal circuit and its association with PASAT‐3 performance in people with multiple sclerosis(MS). We use Granger causality analysis of resting‐state functional MRI from 52 people with MS and 36 healthy people to infer that reduced EC in the afferent limb of the dorsolateral prefrontal circuit occurs in the people with MS with cognitive dysfunction (left: p = .006; right: p = .029), with bilateral EC reductions in this circuit resulting in more severe cognitive dysfunction than unilateral reductions alone (p = .002). We show that reduced EC in the afferent limb of the dorsolateral prefrontal circuit mediates the relationship between cognitive performance and macrostrucutral and microstructural alterations of white matter tracts in components of the circuit. Specificity is shown by the absence of any relationship between cognition and EC in the analogous and anatomically proximal motor circuit. We demonstrate good stability of the EC measures in people with MS over an interval averaging 8‐months. Key positive and negative results are replicated in an independent cohort of people with MS. Our findings identify the dorsolateral prefrontal circuit as a potential target for therapeutic strategies aimed at improving cognition in people with MS., Multimodal neuroimaging studies allow testing of biologically plausible models of multiple sclerosis‐related cognitive dysfunction. We used multimodal MRI to demonstrate reduced effective connectivity in the dorsolateral prefrontal circuit correlates with cognitive performance in people with multiple sclerosis and mediates the relationship between structural alterations in the circuit and cognition.

Invisible symptoms have a negative impact on people living with Multiple Sclerosis (MS), related to the very notion that they are "unseen." It is important to understand the notion of "invisibility" in MS, as invisible symptoms are particularly distressing, and there is a paucity of research focussing on their invisible nature and its specific impact. We aimed to systematically identify, appraise and synthesise qualitative research regarding the notion of "invisibility" in relation to people's lived experience of symptoms of MS.Articles meeting inclusion criteria were critically appraised and synthesised using a meta-ethnographic approach.17 articles were identified from six electronic databases. Three third-order themes were presented as aThis review revealed the manner in which people with MS are affected by the invisibility of their symptoms and the various adaptations used to navigate these lived experiences. We highlight the need to improve clinician and public understanding, and to better respond to these experiences. Future research focusing on the exploration of people's experiences of "invisibility" in MS, including the ways in which "invisibility" is managed on a day-to-day basis could raise clinical and public awareness of the impact of "invisibility" and how to provide support for this, thus easing the dilemmas faced by those with MS.IMPLICATIONS FOR REHABILITATIONPeople with Multiple Sclerosis (MS) experience symptoms that are not overtly visible to others, impacting their emotional and social wellbeing negatively.It is important for healthcare professionals to validate MS patients' experiences around "invisibility" and provide appropriate support.Healthcare professionals should address with MS patients any issues around disclosure of their diagnosis to those around them and support them to navigate these decisions.Raising awareness about the impact of "invisibility" for people with MS may help to lessen patient burden and promote understanding amongst healthcare professionals and the general public.

COVID-19 is a concern in people with multiple sclerosis (MS), mostly because of their long-term physical disabilities and immunomodulatory disease-modifying therapies (DMTs). In this community-based pro- spective longitudinal study, we have been monitoring a cohort of people with MS via the web-based platform of the UK MS Register since the start of the COVID-19 outbreak. We report our findings from 17/03/2020 to 15/01/2021.Out of 7344 participants, 883 (12%) have reported a self-diagnosis of COVID-19 of whom 211 had a confirmed clinical or laboratory-based (n=114) diagnosis. No individual DMT increased the likelihood of contracting COVID-19 (with any of the diagnoses as the outcome). Gender (male: female, adjusted OR: 95% CI [0.94: 0.68–1.3]), web-based Expanded Disability Status Scale score (webEDSS; one-point increase, 0.92: 0.84–1.01), and MS duration (one-year increase, 1: 0.98–1.02) were not associated with contracting COVID-19. Younger age (one-year decrease, 1.04: 1.03–1.06), ethnicities other than white (1.95: 1.13–3.34), and relapsing-remitting MS (versus progressive, 1.72: 2.56–1.16) increased the likelihood of contracting COVID-19. Within a median (interquartile range) of 26 (0–72) days follow-up of participants with COVID-19 (n=532), 69% reported full recovery. A higher webEDSS (one-point increase, 0.84: 0.74–0.96) lowered the likelihood of full recovery. Overall, MS-specific factors do not predispose people with MS to contracting COVID-19, but physical disability can delay recovery.afagh.garjani@nottingham.ac.uk

Background: Multiple sclerosis (MS) is a chronic autoimmune, inflammatory neurological disease of the central nervous system (CNS), increasing in incidence and prevalence across both developed and developing countries. Cognitive difficulties are common in MS sufferers with 70% experiencing difficulties in higher-level brain functioning such as planning, attention, problem solving, and memory. Computerised cognitive training programmes may hold promise as a treatment option for improving cognitive function in people with MS, subject to exploring and addressing potential barriers to usability and acceptability. Methods: This study aimed to test the usability and acceptability of a computerised cognitive training intervention—Strengthening Mental Abilities Through Relational Training (SMART) —for people with MS, through a mostly qualitative prefeasibility design (n= 12). There were two phases of testing: (1) initial usability testing via a think-aloud protocol (n= 6) and (2) alpha-testing to assess experienced acceptability over a four-week period of engagement (n= 6). Data from the two phases were subjected to Framework Analysis, wherein we deductively applied the Health IT Usability Evaluation Model and Theoretical Framework of Acceptability to assess usability and acceptability, respectively. Results: Results show SMART to have satisfactory usability with participants reacting positively to the formatting, visuality, and process of the interface. Minor suggestions were made on how best to adapt SMART for people with MS, but the programme and facilitative support were generally perceived to be acceptable, with participants expressing positive feelings about taking part in the intervention, despite associated burdens. Conclusions: This prefeasibility study provides preliminary evidence of the usability and acceptability of SMART as a computerised cognitive training programme for people with MS. We conclude that we can now move forward with a feasibility trial of SMART, with the intention of proceeding to a definitive trial with cost-effectiveness analysis.

A few randomised controlled trials (RCTs) show that Acceptance and Commitment Therapy (ACT) is beneficial for people with Multiple Sclerosis (MS), but the effectiveness of telephone-supported self-help ACT for people with MS with low mood has not been evaluated. We assessed the feasibility of conducting an RCT of an intervention (8 weekly telephone-calls plus a self-help ACT book) compared to treatment-as-usual. Participants’ mood, quality of life, and impact of MS were assessed at baseline and 12 weeks post-randomisation. Some were interviewed to assess feasibility and acceptability. Twenty-seven participants were randomised. Most participants found the trial procedures acceptable. We found a large and significant effect at follow-up, favouring the intervention in reducing anxiety (d=0.84, 95% CI=0.02–1.66). However, the high attrition rate (33% overall) meant that the trial in its current format was not feasible. The intervention needs to be revised following user-testing and feedback before it can be put to a full trial.

Introduction Smoking is a key modifiable risk factor in multiple sclerosis (MS). MS healthcare providers have a central role informing people of the deleterious effects of smoking on MS progression and promote smoking cessation, yet there is limited information about smoking cessation and support provided by these providers. This study aimed to gain an understanding of MS healthcare providers current practices, barriers and facilitators related to providing smoking cessation support for people with MS. Methods A total of 13 MS nurses and 6 neurologists working in public and private MS clinics across Australia were recruited through professional networks and MS organisations. Telephone interviews were conducted, transcribed and evaluated using framework analysis. Results MS nurses and neurologists reported that they routinely assess smoking status of people with MS at initial appointments and less regularly also at follow-up appointments. Clinicians considered it important to provide information about smoking impact on MS health outcomes and advise to cease smoking, but the content and delivery varies. Beyond this, some clinicians offer referral for smoking cessation support, while others stated this was not their responsibility, especially in light of competing priorities. Many were unsure about referral pathways and options, requiring more information, training and resources. Conclusion Results of this research indicate that there is potential to improve support for MS clinicians to promote smoking cessation among people with MS. Smoking cessation support may include tailored patient resources, clinician training and stronger collaboration with smoking cessation service providers.

Exercise-based therapy may improve health status for people with Mild Cognitive Impairment (MCI) or dementia but cannot work without adherence, which has proven difficult. This review aimed to evaluate strategies to support adherence among people with MCI or Dementia and was completed in Nottingham/UK in 2017. A narrative synthesis was used to investigate the effectiveness or usefulness of adherence support strategies. Fifteen adherence support strategies were used including theoretical underpinning (programmes based on behavior change theories), individual tailoring, worksheets and exercise booklets, goal setting, phone calls or reminders, newsletters, support to overcome exercise barriers, information, adaptation periods, individual supervision, support for clinicians, group setting, music, accelerometers/pedometers and emphasis on enjoyable activities. Music was the only strategy that was investigated in a comparative design but was found to be effective only for those who were generally interested in participating in activities. A wide range of adherence support strategies are being included in exercise interventions for people with MCI or dementia, but the evidence regarding their effectiveness is limited.

This meta-review aimed to synthesise evidence on psychosocial adjustment to multiple sclerosis, to identify available treatment models and services for recently diagnosed individuals, and to explore their effectiveness. MEDLINE, CINAHL, EMBASE, PsycINFO, Web of Science, Cochrane Database of Systematic Reviews and grey literature were searched to include systematic reviews on psychosocial adjustment in multiple sclerosis. Two reviewers independently screened and assessed the quality of the selected reviews. Data were synthesised using narrative approach. Overall, thirty systematic reviews were included (with ~131,813 people with multiple sclerosis). A variety of psychosocial factors were identified in relation to adjustment to multiple sclerosis. Seven theoretical models that underpinned the available services and ten different intervention categories (e.g. cognitive behavioural approaches, mindfulness) for adjustment to multiple sclerosis were identified. There was some evidence that these interventions improved quality of life and coping, however, the difference they could make to people's adjustment was inconclusive. It was also difficult to conclude whether these interventions were particularly effective with the newly diagnosed. There is some support for the effectiveness of adjustment interventions. However, there is a need to design and rigorously evaluate support programmes for newly diagnosed people with multiple sclerosis, specifically focusing on information and adjustment support.

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.

BackgroundThere is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression.ObjectiveTo 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.DesignParallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation.SettingAcute and community stroke services in three sites in England.ParticipantsCommunity-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 blindingParticipants 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.InterventionsThe 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 measuresPrimary 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.ResultsForty-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.LimitationsTarget recruitment was not achieved, although we identified methods to improve recruitment.ConclusionsThe 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 registrationCurrent Controlled Trials ISRCTN12715175.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.

Background\ud Infections can trigger exacerbations of multiple sclerosis (MS). The effects of the coronavirus disease 2019 (COVID-19) on MS are not known. The aim of this study was to understand the impact of COVID-19 on new and pre-existing symptoms of MS.\ud Methods\ud The COVID-19 and MS study is an ongoing community-based, prospective cohort study conducted as part of the United Kingdom MS Register. People with MS and COVID-19 were invited by email to complete a questionnaire about their MS symptoms during the infection. An MS exacerbation was defined as developing new MS symptoms and/or worsening of pre-existing MS symptoms.\ud Results\ud Fifty-seven percent (230/404) of participants had an MS exacerbation during their infection; 82 developed new MS symptoms, 207 experienced worsened pre-existing MS symptoms, and 59 reported both. Disease modifying therapies (DMTs) reduced the likelihood of developing new MS symptoms during the infection (OR 0.556, 95%CI 0.316–0.978). Participants with a higher pre-COVID-19 webEDSS (web-based Expanded Disability Status Scale) score (OR 1.251, 95%CI 1.060–1.478) and longer MS duration (OR 1.042, 95%CI 1.009–1.076) were more likely to experience worsening of their pre-existing MS symptoms during the infection.\ud Conclusion\ud COVID-19 infection was associated with exacerbation of MS. DMTs reduced the chance of developing new MS symptoms during the infection.

There has been a recent trend for the construct of addiction to be applied to sexual behaviours. A growing number of people recounting excessive sexual thoughts or behaviours have been categorized as suffering from sex “addiction”. Sex addiction is said to involve a pathological relationship to sex, with the symptomology akin to drug dependence. Opposing interpretations have argued that sex addiction is used as a stigmatizing label for those who deviate from a socially constructed sexual standard. A Foucauldian form of discourse analysis was used to analyse semi-structured interviews with nine men who identified as sex-addicts or as highly sexual though not addicted to sex. Our analysis explores how sexual addiction is constructed by some interviewees, and focuses on the discursive theme of losing control, used by interviewees to construct their positioning and moral status. Socio-political and ideological connotations of a loss of control were constructed using psychological and biomedical discou...

This qualitative study explores how older gay Irish men understand and construct their sexual identity. In-depth semi-structured interviews were conducted to understand experiences and perceptions of being an older gay person in Ireland and the UK. Using thematic analysis we identified three themes: (i) experiences of sexual awareness and identity conflict; (ii) the dilemma of ‘staying in’ vs. ‘coming out’; (iii) dealing with identity conflict. The results suggested that many men faced challenges and barriers (both religious and cultural) to constructing a stable identity. We examined ways in which these identity conflicts were created and demonstrated how the men developed strategies to minimise these conflicts. Recommendations are provided for improved understanding of sexuality issues concerning minority clients within therapeutic work.

To test whether a widely used model of adjustment to illness, the self-regulatory model, explains the patterns of distress during acute hematopoietic stem cell transplantation (HSCT). According to the model, perceptions of HSCT, coping, and coping appraisals are associated with distress. .Longitudinal, correlational. .The Centre for Clinical Haematology at Nottingham City Hospital and the Department of Haematology at Royal Hallamshire Hospital in Sheffield, both in the United Kingdom. .45 patients receiving mostly autologous transplantations for a hematologic malignancy. .Patients were assessed at baseline, on transplantation day, and two and four weeks after transplantation using three questionnaires.Psychological distress, including depression, anxiety, stress, and overall distress (DASS-21); use of different coping styles (Brief COPE); and perceptions of HSCT and coping appraisals (Brief IPQ). .As suggested by the self-regulatory model, greater distress was associated with negative perceptions of HSCT, controlling for the effects of confounding variables. Mixed support was found for the model's predictions about the impact of coping styles on distress. Use of active and avoidant coping styles was associated with more distress during the acute phase after HSCT. .Negative perceptions of HSCT and coping contribute to psychological distress during the acute phase after HSCT and suggest the basis for intervention. .Eliciting and discussing patients' negative perceptions of HSCT beforehand and supporting helpful coping may be important ways to reduce distress during HSCT.

This article reports the results of an evaluation of the teaching of philosophy of science on clinical psychology training programmes. The implications of the evaluation for engagement with philosophy of science on training courses are discussed and specific recommendations made.

Introduction Self-perceived pornography addiction (SPPA) has increasingly emerged as a concept in research and popular culture, and commentators warn of the reported negative impact that it has. Despite this, “pornography or porn addiction” is not a formally recognized disorder and there is disagreement among researchers regarding its definition or even its existence. Therefore, how SPPA is operationalized often varies, and this is likely to influence the conclusions made about the impact of SPPA. Aim This review aimed to examine what the supposed impact of SPPA is, and how the concept is operationalized. Methods A systematic review of quantitative and qualitative peer-reviewed journal articles was conducted. The following databases were searched up to November 2015: CINAHL (2001–2015), Embase (1974–2015), Medline (1946–2015), PsychARTICLES (1980), and PsychInfo (1806–2015). Terms used were porn*, sexually explicit material, SEM, erotic*, nonparaphilic, cyberpornography, addict*, problematic, excess*, compul*, impul*, impact, effec*, behav*, and cause. An asterisk after a term means that all terms that begin with that root were included in the search. Main Outcome Measures A review of the the current literature pertaining to SPPA and its reported impact. Results We found that SPPA is most frequently operationalized as excessive pornography use and negative consequences. As a result, researchers tended to focus on the frequency of pornography use and related impact as determinants of SPPA. SPPA is reported to affect users and their partners in similar ways, such as increased feelings of isolation and relationship breakdowns. However, we found some methodologic limitations of the primary studies, which limit the strength of the conclusions that can be drawn. Limitations include the lack of representative samples and inadequate measurements of SPPA and its impact. Conclusion There still exist a debate regarding the definition and etiology of SPPA as distinct from self-perceived sex addiction. As such, the research landscape is shaped by different theoretical perspectives. Without evidence to suggest one theoretical position as superior to another, clinicians might be at risk of recommending treatment that is in line with their theoretical perspective (or personal biases) but at odds with the motivations driving an individual to engage in particular sexual behaviors. In light of these findings, the review concludes with recommendations for future research.

Background: Depression is common in multiple sclerosis (MS); however, its assessment is complicated by biological processes. In this context it is important to consider the performance of depression screening measures including that their factor structure is consistent with expectation. This study sought to identify the factor structure of the Center for Epidemiological Study - Depression Scale (CES-D) in people with MS (PwMS). Methods: Participants (N = 493) were those who had consented to take part in a large three-phase longitudinal study of depression in PwMS. CES-D questionnaires completed at phase 1 of the study were utilised. An error in the questionnaire meant it was most appropriate to consider data for 19 of the 20 CES-D questionnaire items. The data was split into two samples by a random selection process to create an exploratory, model development sample and a validation sample. The first sample was subject to confirmatory factor analysis. Following examination of model fit and specification errors, the original model was modified. The revised model was tested in the confirmation sample to assess reproducibility. Results: The analysis results supported the original four factor solution for the CES-D, that is: Depressed Affect, Positive Affect, Somatic Complaints/Activity Inhibition, and Interpersonal Difficulties. Conclusions: The CES-D appears to have a coherent structure with which to examine depression in PwMS.

Background:The role of nurses in managing painful knee OA has been advocated but whether nurses can deliver such interventions as a package of care is unknown.The overall aim of this research is to develop and test a nurse-led complex intervention for knee pain comprising non-pharmacological and pharmacological components. In the first study phase, we report on fidelity and acceptability of a non-pharmacological intervention, to resolve possible challenges to delivery.Objectives:To evaluate fidelity of delivery and acceptability of non-pharmacological components of a complex intervention.Methods:This was a mixed-methods study. Participants with chronic knee pain were recruited from the community to receive the intervention, delivered in 4-sessions over a 5-week period by a trained research nurse. The intervention consisted of holistic assessment, patient education and advice, aerobic and strengthening exercise and weight-loss advice if required. All sessions were video-recorded. Fidelity checklists were completed by the nurse (nurse-rated) and two researchers from the video-recordings (video-rated). Median fidelity scores (%) and interquartile ranges (IQR) were calculated for each component and each session. Semi-structured interviews were conducted with participants. These were audio recorded, transcribed and analysed following the framework approach.Results:18 participants (34% women), with a mean (SD) age and BMI of 68.7 (9.0) years and 31.2 (8.4) kg/m2, took part in the study. Of these, 14 completed all visits. In total, 62 intervention sessions were assessed for fidelity. Overall fidelity was rated high by both nurse-rated scores (97.7%) and video-rated scores (84.2%). The level of agreement between nurse-rated and video-recorded methods was 73.3% (CI 71.3, 75.3) and the inter-rater agreement was 65.5% (CI 60.3, 70.5). Fidelity of delivery was lower for advice on footwear modification and walking aids in all sessions and moderate for education in session 1 and for exercise in session 4 (Table 1).Table 1.Fidelity scores of the components of the intervention for each session,Intervention componentsSession 1*Session 2*Session 3*Session 4*Education78.1 (74.1, 93.7)87.5 (50, 100)87.5 (50, 100)100 (93.7, 100)Exercise94.4 (88.9, 100)88.9 (75, 94)86.1 (72, 100)75 (67.6, 82.8)Adjunctive treatments50 (45.83, 100)0 (0, 50)50 (0, 100)-*median (IQR)17 participants were interviewed. Most found advice supplied straightforward. They were satisfied with the package, which changed their perception of managing knee pain, understanding it can be improved though self-management. However, too much information was provided in a short time-span and it was difficult to fit exercises into their daily routine.Conclusion:Delivery of a non-pharmacological intevention by a nurse is feasible within a research setting. Most components of the intervention were delivered as intended, except for advice about the use of adjunctive treatment.Acknowledgments:This research was funded by the NIHR Nottingham BRC and Pain Centre Versus ArthritisDisclosure of Interests:Polykarpos Angelos Nomikos: None declared, Amy Fuller: None declared, Michelle Hall: None declared, Bonnie Millar: None declared, Reuben Ogollah: None declared, Michael Doherty: None declared, Roshan Nair Speakers bureau: Financial support from pharmaceutical companies (Biogen and Novartis) to present lectures at events related to psychological support for people with multiple sclerosis (Speaker’s bureau)., David Walsh Grant/research support from: 2016: Investigator-led grant from Pfizer Ltd (ICRP) on Pain Phenotypes in RA; non-personal financial disclosure (payment to University)., Consultant of: DAW has undertaken paid consultancy to Pfizer Ltd, Eli Lilly and Company and GSK Consumer Healthcare., Paid instructor for: 2019: Consultancy to Love Productions; consultancy on programme design, contribution to programme content on self-management of chronic pain (payments to University)2019: Consultancy to AbbVie Ltd; 13.06.19; presentation on RA pain at EULAR, Madrid, and webinar (payments to University).2019: Consultancy to Eli Lilly and Company Ltd. 06.06.19 Centre for Collaborative Neuroscience, Windlesham, Surrey, UK (payment to University).2019: Consultancy to Pfizer (payment to University).2018: Consultancy to Pfizer. 07.12.18. USA. 1 day. Tanezumab (payment to University).2018: Consultancy to Pfizer. 23.11.18. Manchester UK. 1 day. Tanezumab (payment to University).2018: Consultancy to Pfizer. 1.11.18. Skype. 4h. Tanezumab (payment to University).2018: Consultancy to GlaxoSmithKline Plc. 1 day. Pain in RA and anti-GM-CSF (payment to University).2018: Consultancy to Pfizer Ltd; Presentation at OARSI; non-personal financial disclosure (payment to University)2018: Consultancy to Pfizer Ltd; Patient preference study; non-personal financial disclosure (payment to University)2017: Consultancy to Pfizer Ltd; personal financial disclosure2017: Consultancy to Pfizer Ltd through Nottingham University; non-personal financial disclosure (payment to University).2015: Consultancy to GSK Consumer Healthcare; personal financial disclosure., Speakers bureau: 2019: Irish Society of Rheumatology: speaker fees (personal pecuniary), Ana Valdes Grant/research support from: Awarded a grant from Pfizer, Abhishek Abhishek: None declared

Increasingly, society is acknowledging that people with intellectual disabilities (PWID) have sexual needs. This shift is reflected in international policy, with sexual expression acknowledged a basic human right for PWID. Staff that care for PWID have a responsibility to ensure this right is upheld. Though they generally report accepting views of PWID’s sexual expression, PWID report that their sexual expression is restricted by care staff. A lack of service-level policy regarding PWID’s sexual expression and how to support them in this, leaves care staff confused, and lacking confidence to make decisions about PWID’s care. Clinical Psychologists work with care staff who experience these difficulties. Though pockets of good practice are emerging, there is no guidance on how to best approach this work. This research sought to utilise the good practice already occurring. We used the Delphi Method to develop a set of consensus-based good practice guidelines for Clinical Psychologists working with care staff around supporting PWID’s sexual expression. We conducted the Delphi across three rounds, with a panel of 17 Clinical Psychologists experienced in helping care staff support sexual expression in PWID. In Round One, the primary researcher interviewed panel members about clinical experiences and they each suggested three potential good practice guidelines. We then compiled the Round Two survey, in which all 51 suggested guidelines could be rated in terms of importance and sent it to all panel members. We developed the Round Three survey using the responses to Round Two, personalised to include information on how the 51 guidelines had been rated by the individual panel member and the panel as a whole. The Round Three survey gave panel members the option to amend their responses. Consensus that a guideline was important or essential (set at ≥90% agreement, a priori), meant it was included in the final set. We supplemented endorsed guidelines with vignettes based on the practice described in the Round One interviews. The panel reached consensus that 12 guidelines were important or essential. These guidelines fell under four themes: ‘Addressing staff attitudes’, ‘Addressing uncertainty about rights and responsibilities of PWID’, ‘Locating the problem, being part of the solution’, and ‘Supporting care staff to understand and reflect upon their role’. The limitations of this study include the homogenous sample and that the effectiveness of the practice Clinical Psychologists cited as evidence was not independently corroborated. This research provided insight into the important role Clinical Psychologists play in helping care staff support PWID’s sexual expression. Direct work with care staff to clarify their understanding of PWID’s rights, and to normalise and encourage reflection on the values care staff hold, were both considered central to the role. In addition, the panel suggested that Clinical Psychologists must put to use their unique professional skillset to share understanding about how organisational approaches are maintaining the gap between policy and practice, and what needs to be done about it.

Background: Post-stroke fatigue (PSF) is one of the most common and frustrating outcomes of stroke. It has a high prevalence and it can persist for many years after stroke. PSF itself contributes to a wider range of undesirable outcomes that affect all aspects of daily life. The aim of this review was to identify and summarise the most recent research on PSF, in order to update the evidence base.Methods: We updated an existing review (Hinkleet al. 2017) systematically searching CINAHL, MEDLINE, PsycINFO, and PubMed to cover new research studies between 1stMarch 2016 and the search date (19thJanuary 2020). We included interventional and observational research, and clinical practice guidelines that were not covered in the original review. After duplicate removal in EndNote, two reviewers screened the search results in Rayyan, and data from eligible full texts were extracted onto an Excel spreadsheet. Finally, we used RobotReviewer and a human reviewer to assess the risk of bias of randomised trials for this scoping review.Results: We identified 45 records for 30 studies (14 observational, 10 interventional studies, and 6 guidelines). Apart from one, the interventional studies were single-centred, had high risk of bias and small sample size (median 50). They investigated exercise, pharmacotherapy, psychotherapy, education, and light therapy. Observational studies mainly reported the factors related to PSF including co-morbidities, depression and anxiety, quality of life, activities of daily living, stroke severity, medication use and polypharmacy, polymorphism, pain, apathy, limb heaviness, neuroticism, mobility, and thyroid-stimulating hormone. Guidelines either did not report on PSF or, when reported, their recommendations were supported by little or low level of evidence.Conclusion: Although we identified a number of recent studies which have added to our current knowledge on PSF, none are robust enough to change current clinical practice.

Introduction We are conducting a randomised controlled trial (Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment - PrAISED 2) to test the effectiveness of an intervention to promote activity and independence amongst people with mild cognitive impairment and early dementia. A process evaluation is needed to determine how the intervention works. This protocol outlines the rationale, aims, objectives and methods of the process evaluation. Methods The process evaluation will use a mixed-methods design and comprise two studies: An implementation study, examining the process through which PrAISED 2 is delivered, and a study on the mechanisms of impact and context, focussing on the mediating mechanisms that contribute to study outcomes. Integration of separate analyses of quantitative and qualitative data will provide a holistic view of how the PrAISED 2 intervention works. Conclusion Results from this process evaluation will further the understanding of the factors that can impinge on the success of complex interventions. This will represent invaluable information for researchers undertaking further research around behaviour change among people with cognitive impairment and dementia.