Developing consensus-based clinical competencies to guide stroke clinicians in the implementation of psychological care in aphasia rehabilitation.

Background People with aphasia experience depression and anxiety associated with negative outcomes across a range of time post-stroke. Stroke clinicians are well-positioned to facilitate low-intensity psychotherapeutic interventions after aphasia (e.g. mood screening, behavioural activation, problem-solving therapy, relaxation therapy); however, they self-report a lack of knowledge, skills and confidence to do so. The Theoretical Domains Framework (TDF) provides a lens through which to view and target clinician behaviours and training needs in this area of practice. The aim of this study was to develop and gain consensus on items for a rating scale of clinical competencies in facilitating individual-based, low-intensity psychotherapeutic interventions for people with aphasia. Methods An e-Delphi methodology using focus groups and survey rounds was used to gain consensus on clinical competencies considered important. Results Eight stroke clinicians (speech pathologists and psychologists), two people with aphasia and three family members participated in one of four focus groups. Four themes were derived from the data: (1) Communication support, (2) Assessment and therapy structure, (3) Interpersonal skills, and (4) Needs of the significant other (family or friend). Themes informed an initial list of 23 self-rated and observer-rated competency items. Following two rounds of e-Delphi surveys, 11 stroke clinicians (six speech pathologists and five psychologists) reached consensus (80-100%) for 19 competencies. Conclusions The Psychological Care in Aphasia Rehabilitation Competency scale offers a preliminary list of items to guide and train clinicians to implement low-intensity psychotherapeutic interventions for people with aphasia.

Long-term psychological outcomes following stroke: the OX-CHRONIC study.

BACKGROUND: Stroke survivors rate longer-term (> 2 years) psychological recovery as their top priority, but data on how frequently psychological consequences occur is lacking. Prevalence of cognitive impairment, depression/anxiety, fatigue, apathy and related psychological outcomes, and whether rates are stable in long-term stroke, is unknown. METHODS: N = 105 long-term stroke survivors (M [SD] age = 72.92 [13.01]; M [SD] acute NIH Stroke Severity Score = 7.39 [6.25]; 59.0% Male; M [SD] years post-stroke = 4.57 [2.12]) were recruited (potential N = 208). Participants completed 3 remote assessments, including a comprehensive set of standardized cognitive neuropsychological tests comprising domains of memory, attention, language, and executive function, and questionnaires on emotional distress, fatigue, apathy and other psychological outcomes. Ninety participants were re-assessed one year later. Stability of outcomes was assessed by Cohen's d effect size estimates and percent Minimal Clinically Important Difference changes between time points. RESULTS: On the Montreal Cognitive Assessment 65.3% scored < 26. On the Oxford Cognitive Screen 45.9% had at least one cognitive impairment. Attention (27.1%) and executive function (40%) were most frequently impaired. 23.5% and 22.5% had elevated depression/anxiety respectively. Fatigue (51.4%) and apathy (40.5%) rates remained high, comparable to estimates in the first-year post-stroke. Attention (d = -0.12; 85.8% stable) and depression (d = 0.09, 77.1% stable) were the most stable outcomes. Following alpha-adjustments, only perceptuomotor abilities (d = 0.69; 40.4% decline) and fatigue (d = -0.33; 45.3% decline) worsened over one year. Cognitive impairment, depression/anxiety, fatigue and apathy all correlated with worse quality of life. CONCLUSION: Nearly half of participants > 2 years post-event exhibited psychological difficulties including domains of cognition, mood, and fatigue, which impact long-term quality of life. Stroke is a chronic condition with highly prevalent psychological needs, which require monitoring and intervention development.

Developing a patient care pathway for emotional support around the point of multiple sclerosis diagnosis: A stakeholder engagement study.

BACKGROUND: Diagnosing multiple sclerosis (MS) can be a lengthy process, which can negatively affect psychological well-being, condition management, and future engagement with health services. Therefore, providing timely and appropriate emotional support may improve adjustment and health outcomes. PURPOSE: To develop a patient care pathway for providing emotional support around the point of diagnosing MS, and to explore potential barriers and facilitators to delivery and implementation. METHODS: Focus groups were conducted with 26 stakeholders, including 16 people living with MS, 5 carers/family members and 5 professionals working with people living with MS (3 MS nurses, 1 psychiatrist, and 1 charity staff member). Discussions were audio-recorded, transcribed verbatim and analyzed using framework analysis. RESULTS: Participants suggested that a patient care pathway should include comprehensive information provision as a part of emotional support at diagnosis, and follow-up sessions with a healthcare professional. Barriers including increasing staff workloads and financial costs to health services were acknowledged, thus participants suggested including peer support workers to deliver additional emotional support. All participants agreed that elements of a care pathway and embedded interventions should be individually tailored, yet provided within a standardized system to ensure accessibility. CONCLUSIONS: A patient care pathway was developed with stakeholders, which included an embedded MS Nurse support intervention supplemented with peer support sessions. Participants suggested that the pathway should be delivered within a standardized system to ensure equity of service provision across the country. PATIENT OR PUBLIC CONTRIBUTION: This research was conceptualized and designed collaboratively with Nottingham Multiple Sclerosis Patient and Public Involvement and Engagement (PPIE) group members. One member is a co-author and was actively involved in every key stage of the research process, including co-design of the pathway and research protocol, data collection (including presenting to participants and moderating group discussions), analysis and write-up. Authors consulted with PPIE members at two meetings (9 and 11 PPIE attendees per meeting) where they gave feedback on the research design, findings and the resulting pathway. People living with MS and carers of people with MS were included in the focus groups as participants.

Psychological interventions for post stroke pain: A systematic review.

Chronic pain is prevalent after stroke and has a significant impact on quality of life. Research demonstrates the efficacy of psychological interventions for mixed chronic pain conditions. This review aimed to assess evidence on the effectiveness of psychological interventions for chronic pain in people with stroke. PubMed, PsychINFO, Embase, and CINAHL were searched from inception to 31 January 2021 at all levels of evidence. Psychological interventions assessing chronic pain in adults following stroke as a primary outcome were included. All outcomes related to pain quality were included (e.g., intensity, frequency, duration). Study quality was assessed using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Case Reports and Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Three single n case reports were included. A narrative synthesis was performed, indicating that psychological interventions may reduce chronic post-stroke pain; however, overall quality appraisal of the included studies was poor, owing to the low internal validity found in the single-n case report designs. The limited evidence suggests that psychological interventions may have clinical utility in reducing chronic post-stroke pain. However, owing to the paucity and quality of studies found, the results must be treated with caution. More rigorous research is needed.

How do stroke survivors and their caregivers manage post-stroke fatigue? A qualitative study.

OBJECTIVES: The primary objective was to gain insight into the lived experiences of using day-to-day strategies to manage post-stroke fatigue. DESIGN: Qualitative, descriptive study. SETTING: Community telephone interviews. PARTICIPANTS: A purposive sample of 20 stroke survivors with current, or previous, post-stroke fatigue, and 8 caregivers, who provided informal care or support, were recruited. MAIN MEASURES: Semi-structured telephone interviews were undertaken. Data were analysed using a framework approach. RESULTS: Most participants had found their own ways of coping and their personal strategies included acceptance of having fatigue; 'pacing' (spreading activities out and interspersing with rest periods); keeping a diary in order to plan activities and to identify 'trigger' activities which induced fatigue; talking to (and educating) others about having fatigue; using relaxation; and accessing professional advice and support. The burden placed on caregivers was considerable and they often had to oversee the post-stroke fatigue management strategies used. CONCLUSIONS: Post-stroke fatigue is managed in different ways and there was not one particular strategy that seemed effective for everyone. Most people in our study had had to devise their own ways of coping practically. Given the scale of this problem, which profoundly impacts the lives of both stroke survivors and caregivers, the management of post-stroke fatigue merits more attention and evaluation. However, this must be directly informed by those with lived experience.

A pilot economic evaluation of a feasibility trial for SUpporting wellbeing through PEeR-Befriending (SUPERB) for post-stroke aphasia.

OBJECTIVES: To explore the feasibility of a full economic evaluation of usual care plus peer-befriending versus usual care control, and potential cost-effectiveness of peer-befriending for people with aphasia. To report initial costs, ease of instruments' completion and overall data completeness. DESIGN: Pilot economic evaluation within a feasibility randomised controlled trial. SETTING: Community, England. PARTICIPANTS: People with post-stroke aphasia and low levels of psychological distress. INTERVENTION: All participants received usual care; intervention participants received six peer-befriending visits between randomisation and four months. MAIN MEASURES: Costs were collected on the stroke-adapted Client Service Receipt Inventory (CSRI) for health, social care and personal out-of-pocket expenditure arising from care for participants and carers at 4- and 10-months post-randomisation. Health gains and costs were reported using the General Health Questionnaire-12 and the EQ-5D-5L. Mean (CI) differences for costs and health gains were reported and uncertainty represented using non-parametric bootstrapping and cost-effectiveness acceptability curves. RESULTS: 56 participants were randomised. Mean age was 70.1 (SD 13.4). Most (n = 37, 66%) had mild and many (n = 14; 25%) severe aphasia. There was ≥94% completion of CSRI questions. Peer-befriending was higher in intervention arm (p < 0.01) but there were no significant differences in total costs between trial arms. Peer-befriending visits costed on average £57.24 (including training and supervision costs). The probability of peer-befriending being cost-effective ranged 39% to 66%. CONCLUSIONS: Economic data can be collected from participants with post-stroke aphasia, indicating a full economic evaluation within a definitive trial is feasible. A larger study is needed to demonstrate further cost-effectiveness of peer-befriending.

A Biopsychosocial Intervention for Stroke Carers (BISC): development and description of the intervention.

OBJECTIVE: Family members of stroke survivors are often not supported for their caring role, with many reporting adjustment difficulties. This paper describes the development and content of a group-based intervention for informal carers of stroke survivors. METHOD: The intervention is based on the theoretical foundation of the biopsychosocial model with the aim to understand and address the physical, psychological and social factors of caring for stroke survivors. Findings from a comprehensive literature review and a qualitative study with carers and stroke professionals were synthesized to guide the intervention development. The Template for Intervention Description and Replication (TIDieR) checklist was used as a framework to describe the intervention. RESULTS: The intervention integrates cognitive-behavioural approaches via the identification of the biopsychosocial (physical, emotional, social) factors that can have an impact on the well-being of carers. It includes education on stroke-specific topics and advice on coping strategies. It consists of six structured two-hour group sessions facilitated in a community setting. It provides information and support on adjusting to the caring role in the first year post-stroke. Intervention materials were designed for addressing carers' specific needs using psychological techniques, such as problem-solving, goal setting and relaxation exercises. CONCLUSION: We have underlined the importance for describing and reporting the process of intervention development for complex interventions in the context of stroke rehabilitation. An intervention addressing the needs of informal stroke carers (Biopsychosocial Intervention for Stroke Carers; BISC) has been developed and described. BISC was further evaluated in a single-centre feasibility randomized controlled trial.

SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia.

OBJECTIVE: To evaluate systematically the fidelity of a peer-befriending intervention for people with aphasia. DESIGN: SUpporting wellbeing through Peer-befriending (SUPERB) was a feasibility randomised controlled trial comparing usual care to usual care +peer-befriending. This paper reports on the fidelity of all intervention aspects (training and supervision of providers/befrienders; intervention visits) which was evaluated across all areas of the Behaviour Change Consortium framework. SETTING: Community. PARTICIPANTS: People with aphasia early poststroke and low levels of distress, randomised to the intervention arm of the trial (n=28); 10 peer-befrienders at least 1-year poststroke. INTERVENTION: Peer-befrienders were trained (4-6 hours); and received regular supervision (monthly group while actively befriending, and one-to-one as and when needed) in order to provide six 1-hour peer-befriending visits over 3 months. MAIN MEASURES: Metrics included number and length of training, supervision sessions and visits. All training and supervision sessions and one (of six) visits per pair were rated against fidelity checklists and evaluated for inter-rater and intrarater reliability (Gwets AC1 agreement coefficient). Per-cent adherence to protocol was evaluated. RESULTS: All peer-befrienders received 4-6 hours training over 2-3 days as intended. There were 25 group supervision sessions with a median number attended of 14 (IQR=8-18). Twenty-six participants agreed (92.8%) to the intervention and 21 (80.8%) received all six visits (median visit length 60 min). Adherence was high for training (91.7%-100%) and supervision (83%-100%) and moderate-to-high for befriending visits (66.7%-100%). Where calculable, inter-rater and intrarater reliability was high for training and supervision (Gwets AC1 >0.90) and moderate-to-high for intervention visits (Gwets AC1 0.44-1.0). CONCLUSION: Planning of fidelity processes at the outset of the trial and monitoring throughout was feasible and ensured good-to-high fidelity for this peer-befriending intervention. The results permit confidence in other findings from the SUPERB trial. TRIAL REGISTRATION NUMBER: NCT02947776.

Solution Focused Brief Therapy in Post-Stroke Aphasia (SOFIA): feasibility and acceptability results of a feasibility randomised wait-list controlled trial.

OBJECTIVES: The Solution Focused Brief Therapy in Post-Stroke Aphasia feasibility trial had four primary aims: to assess (1) acceptability of the intervention to people with aphasia, including severe aphasia, (2) feasibility of recruitment and retention, (3) acceptability of research procedures and outcome measures, and (4) feasibility of delivering the intervention by speech and language therapists. DESIGN: Two-group randomised controlled feasibility trial with wait-list design, blinded outcome assessors and nested qualitative research. SETTING: Participants identified via two community NHS Speech and Language Therapy London services and through community routes (eg, voluntary-sector stroke groups). PARTICIPANTS: People with aphasia at least 6 months post stroke. INTERVENTION: Solution-focused brief therapy, a psychological intervention, adapted to be linguistically accessible. Participants offered up to six sessions over 3 months, either immediately postrandomisation or after a delay of 6 months. OUTCOME MEASURES: Primary endpoints related to feasibility and acceptability. Clinical outcomes were collected at baseline, 3 and 6 months postrandomisation, and at 9 months (wait-list group only). The candidate primary outcome measure was the Warwick-Edinburgh Mental Well-being Scale. Participants and therapists also took part in in-depth interviews. RESULTS: Thirty-two participants were recruited, including 43.8% with severe aphasia. Acceptability endpoints: therapy was perceived as valuable and acceptable by both participants (n=30 interviews) and therapists (n=3 interviews); 93.8% of participants had ≥2 therapy sessions (90.6% had 6/6 sessions). Feasibility endpoints: recruitment target was reached within the prespecified 13-month recruitment window; 82.1% of eligible participants consented; 96.9% were followed up at 6 months; missing data <0.01%. All five prespecified feasibility progression criteria were met. CONCLUSION: The high retention and adherence rates, alongside the qualitative data, suggest the study design was feasible and therapy approach acceptable even to people with severe aphasia. These results indicate a definitive randomised controlled trial of the intervention would be feasible. TRIAL REGISTRATION NUMBER: NCT03245060.

"Now I Am Myself": Exploring How People With Poststroke Aphasia Experienced Solution-Focused Brief Therapy Within the SOFIA Trial.

Aphasia, a language disability, can profoundly affect a person's mood and identity. The experiences of participants who received Solution-Focused Brief Therapy, a psychological intervention, were explored in the Solution-Focused brief therapy In poststroke Aphasia (SOFIA) Trial. Thirty participants with chronic aphasia, 14 with severe aphasia, participated in in-depth interviews that were analyzed using framework analysis. Two overarching themes emerged: valued therapy components (exploring hopes, noticing achievements, companionship, sharing feelings, and relationship with therapist) and perceptions of progress (mood, identity, communication, relationships, and independence). Participants were categorized into four groups: (a) "changed," where therapy had a meaningful impact on a person's life; (b) "connected," where therapy was valued primarily for companionship; (c) "complemental," where therapy complemented a participant's upward trajectory; and (d) "discordant," where therapy misaligned with participants' preference for impairment-based language work. This study suggests that it is feasible to adapt a psychological therapy for people with aphasia, who perceive it as valuable.

'Emotion is of the essence. Number one priority': A nested qualitative study exploring psychosocial adjustment to stroke and aphasia.

BACKGROUND: Stroke and aphasia can have a profound impact on people's lives, and depression is a common, frequently persistent consequence. Social networks also suffer, with poor social support associated with worse recovery. It is essential to support psychosocial well-being post-stroke, and examine which factors facilitate successful adjustment to living with aphasia. AIMS: In the context of a feasibility randomized controlled trial of peer-befriending (SUPERB), this qualitative study explores adjustment for people with aphasia in the post-acute phase of recovery, a phase often neglected in previous research. METHODS & PROCEDURES: Semi-structured interviews were conducted with 20 people with aphasia and 10 significant others, who were purposively sampled from the wider group of 56 people with aphasia and 48 significant others. Interviews took place in participants' homes; they were analysed using framework analysis. OUTCOMES & RESULTS: Participants with aphasia were 10 women and 10 men; their median (interquartile range-IQR) age was 70 (57.5-77.0) years. Twelve participants had mild aphasia, eight moderate-severe aphasia. Significant others were six women and four men with a median (IQR) age of 70.5 (43-79) years. They identified a range of factors that influenced adjustment to aphasia post-stroke. Some were personal resources, including mood and emotions; identity/sense of self; attitude and outlook; faith and spirituality; and moving forward. Significant others also talked about the impact of becoming carers. Other factors were external sources of support, including familial and other relationships; doctors, nurses and hospital communication; life on the ward; therapies and therapists; psychological support, stroke groups; and community and socializing. CONCLUSIONS & IMPLICATIONS: To promote adjustment in the acute phase, hospital staff should prioritize the humanizing aspects of care provision. In the post-acute phase, clinicians play an integral role in supporting adjustment and can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy. What this paper adds What is already known on the subject Anxiety and depression are common consequences of stroke, with depression rates high at 33% at 1 year post-onset. There is evidence that the psychological needs of people with aphasia are even greater than those of the general stroke population. Social support and social networks are also negatively impacted. Few studies have examined adjustment when people are still in hospital or in the early stages of post-stroke life in the community (< 6 months). Further, many stroke studies exclude people with aphasia. What this paper adds to existing knowledge Adjustment to living with stroke and aphasia begins in the early stages of recovery. While this partly depends on personal resources, many factors depend on external sources of help and support. These include doctors, nurses and hospital communication, their experience of life on the ward, and their therapists' person-centred care. What are the potential or actual clinical implications of this work? Clinicians play an integral role in facilitating people with aphasia to utilize their personal resources and support systems to adjust to life after stroke. They can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy.

Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial.

OBJECTIVE: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. DESIGN: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. PARTICIPANTS AND SETTING: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. INTERVENTION: Six 1-hour peer-befriending visits over three months. MAIN MEASURES: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. RESULTS: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, -2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated. CONCLUSIONS: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial.Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke.

A scoping review of psychoeducational interventions for people after transient ischemic attack and minor stroke.

BACKGROUND: Psychoeducation can provide information and support to cope with the physical and emotional effects of a health condition. This scoping review aimed to identify the evidence regarding psychoeducational interventions for people after a Transient Ischemic Attack (TIA) and minor stroke. METHODS: This review was conducted in accordance with the PRISMA Extension for Scoping Reviews. Three electronic databases (MEDLINE, Embase, PsycINFO) were searched for articles on interventions related to psychoeducational support post-TIA and minor/mild stroke. Search retrieved 3722 articles. Three reviewers independently screened titles, abstracts, full-texts, and extracted data for included studies. Study quality was assessed using the JADAD scale. TIDieR checklist was used to describe interventions. RESULTS: Fifteen RCTs were included. Twelve studies were of high quality (JADAD score ≥2), two were of low quality. A total of 1500 participants were recruited across studies. Definition of TIA and minor stroke was unclear, leading to the exclusion of several studies. Various interventions were included, including education/psychoeducation (n = 4); exercise and lifestyle advice (n = 3); telephone-based education/counseling (n = 3); secondary prevention education (n = 1); motivational interviewing (n = 2); self-management (n = 2). Interventions were inconsistently described, with information missing about who delivered it and tailoring. CONCLUSIONS: Definitions of stroke severity are not adequately reported. There are a variety of interventions including education about a range of stroke-specific topics. Many interventions are not adequately described, thus making it difficult to determine if the aim was to provide information or support post-TIA/minor stroke. There is a need for an in-depth systematic review to develop a clear definition of psychoeducation.

Assessing Self-Reported Mood in Aphasia Following Stroke: Challenges, Innovations and Future Directions.

Assessment of mood is critical in determining rehabilitation outcomes for stroke and other acquired brain injury, yet a common consequence of such injuries is aphasia, where language is impaired. Consequently, the use of language-based measures in this population is often not possible. Following a critical review of the neuropsychological aspects of self-reported mood, this paper evaluates the problems in reporting mood after stroke due to aphasia, and discusses implications for the design of adapted instruments. The paper then appraises the construction and psychometric properties of existing, adapted self-report measures developed to try and address these problems, and evaluates their utility and limitations. This includes a focus on the recently validated tablet-based Dynamic Visual Analog Mood Scales (D-VAMS), which uses innovative non-verbal assessment methods based on facial expression modulated via a slider control on a touchscreen interface. Currently, most studies evaluating recovery interventions simply omit individuals with aphasia because of the difficulty of assessing mood and quality of life in this population. However, adapted scales such as the D-VAMS appear to represent an important step forward in assessing mood in people with language impairments, with the use of interactive modulated imagery having wider applications for nonverbal communication as well as the quantification of subjective phenomena.

Long-term psychological consequences of stroke (OX-CHRONIC): A longitudinal study of cognition in relation to mood and fatigue after stroke: Protocol.

Background: The long-term psychological consequences of stroke and how cognitive problems change over time after the first-year following stroke remain unclear. Particularly, trajectories of domain-specific and domain-general cognitive functions and how cognition interacts with mood, fatigue and quality of life are not well described. Aims: To determine the prevalence, trajectories and wider impact of domain-specific cognitive impairment in long-term stroke survivors, in relation to mood, fatigue and quality of life. Methods: Participants who previously took part in the Oxford Cognitive Screening study, completed the 6-month follow-up with cognitive, mood, fatigue and quality of life assessments and agreed to be contacted for future research will be recruited into OX-CHRONIC. The eligible cohort is between 2- and 9-years post-stroke. Cognition will be assessed with a detailed neuropsychological battery, alongside questionnaire measures of mood, fatigue, activities of daily life and quality of life measures at two timepoints, 1 year apart. Additionally, medical records will be accessed to extract further clinical information about the stroke and patients may opt-in to wear an activity monitor for 1 week to provide fine-grained measures of sleep and activity. The study protocol and study materials were approved by the national ethics committee (REC Ref: 19/SC/0520). Planned outputs: OX-CHRONIC will provide detailed data on the evolving cognitive profiles of stroke survivors over several years post-stroke. Estimates of long-term prevalence as well as the effect of changes in cognitive profiles on mood, fatigue and quality of life will be examined. This study is funded by a Priority Programme Grant from the Stroke Association (SA PPA 18/100032).

Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study.

OBJECTIVE: To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. DESIGN: Feasibility randomised controlled study with nested qualitative interview study. SETTING: The intervention was delivered in the community in either a group or one-to-one format. SUBJECTS: Carers and stroke survivors within one year of stroke onset. INTERVENTIONS: A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. MAIN OUTCOME: Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). RESULTS: Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. CONCLUSIONS: Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs.

Frequency of anxiety after stroke: An updated systematic review and meta-analysis of observational studies.

BACKGROUND: Anxiety is a common and distressing problem after stroke. AIMS: To undertake an updated systematic review and meta-analysis of observational studies of anxiety after stroke and integrate the findings with those reported previously. SUMMARY OF REVIEW: Multiple databases were searched in May 2018 and 53 new studies were included following dual independent sifting and data extraction. These were combined with 44 previous studies to form a combined data set of 97 studies, comprising 22,262 participants. Studies using interview methods were of higher quality. Rates of anxiety by interview were 18.7% (95% confidence interval 12.5, 24.9%) and 24.2% (95% confidence interval 21.5, 26.9%) by rating scale. Rates of anxiety did not lower meaningfully up to 24 months after stroke. Eight different anxiety subtypes were also reported. CONCLUSIONS: This review confirms that anxiety occurs in around one in four patients (by rating scale) and one in five patients (by interview). More research on anxiety subtypes is needed for an informed understanding of its effects and the development of interventions.

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

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

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

The use of carer perspectives and expert consensus to define key components of a biopsychosocial support intervention for stroke carers.

Objective: To identify the key components of a biopsychosocial support intervention to improve mental wellbeing for informal stroke carers within the first year post-stroke based on the combined perspectives of experts in the field of psychological care after stroke and informal stroke carers themselves. Methods: After reviewing the existing literature a cross-sectional mixed-methods design was adopted comprising 1) focus groups with informal stroke carers about their psychological support needs, and 2) nominal group technique with academic and clinical stroke care experts to reach consensus on intervention priorities. Transcripts were thematically analyzed and combined with the ranked priorities from the nominal group to identify key components for intervention content. Results: Key themes for informal stroke carers were associated with: 1) changes in relationships, roles, and dynamics; 2) emotional impact and acceptance; 3) drawing on inner resources; 4) looking for information, solutions, and explanations; 5) support from others. The expert nominal group placed priority on eight ranked areas: 1) acknowledging "normal" emotions; 2) education about the effects of a stroke; 3) reactions to loss and adjustment; 4) recognizing signs and symptoms of not coping; 5) knowing how and when to access practical and emotional support; 6) strategies for taking care of own health; 7) dealing with difficult emotions; and 8) problem solving skills. Conclusions: Themes from the informal carer focus groups, and ranked priority areas will inform the development of a biopsychosocial support intervention for stroke carers to be tested in a feasibility randomized controlled trial.

Fidelity protocol for the Action Success Knowledge (ASK) trial: a psychosocial intervention administered by speech and language therapists to prevent depression in people with post-stroke aphasia.

INTRODUCTION: Treatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke). METHODS AND ANALYSIS: A novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework. ETHICS AND DISSEMINATION: The study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12614000979651.