ORCID Profile
0000-0003-0704-9387
Current Organisation
University of Nottingham
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Publisher: SAGE Publications
Date: 23-07-2013
Abstract: To assess the treatment integrity of behavioural therapy for low mood in stroke patients with aphasia. Participants were recruited to a multicentre randomized controlled trial (Communication and Low Mood CALM trial) comparing behavioural therapy with a usual care control group. Of the 51 participants randomly allocated to receive behavioural therapy, 44 participants completed treatment. Participants were assessed on measures of disability, language and mood. The number and length of therapy sessions, and therapist was recorded. Allocation of time to therapy components was compared across three phases of therapy. Associations between levels of disability, aphasia, mood and the therapy patients received were determined. Therapy content was compared between centres and at the beginning and end of the trial. The mean number of therapy sessions was 9.1 (range 3–18, SD 2.6) and the mean duration of sessions was 58 minutes (range 30–89 minutes, SD 10.7). Allocation of time to each therapy component significantly differed across the three phases of therapy ( P 0.05). There were no significant associations ( P 0.05) between the length and number of sessions and patients’ aphasia, mood or disability, suggesting similar levels of therapy were provided regardless of patients’ characteristics. The content of therapy showed some differences between centres ( P 0.01) and there was programme drift in some components of therapy. The results support the ability of the therapists to deliver behavioural therapy according to the treatment manual. However there were differences between centres and over time in some components of therapy.
Publisher: SAGE Publications
Date: 24-10-2011
Abstract: Objective: To assess the psychometric properties of an observational screening measure of depressive symptoms (SADQH-10 10-item Hospital version of the Stroke Aphasic Depression Questionnaire) for use in stroke patients with aphasia and to determine the convergent and ergent validity of the SADQH-10. Design: Cross-sectional cohort. Setting: Hospital and community. Participants: Stroke patients with aphasia ( n = 165) were recruited through hospital wards and community services as part of a randomised controlled trial. Participants were aged 29 to 94 years (68.6 ± 12.1) and 65% were men. Results: The SADQH-10 demonstrated good internal consistency (α = 0.77). Factor analysis revealed the SADQH-10 to be measuring three constructs (social interaction and physical pain, tearfulness, loss of interest and motivation). Significant correlations were found between scores on the SADQH-10 and VAMS ‘sad’ item ( r s = 0.297, P 0.01) but not with the VASES ‘depression’ item ( r s = 0.064, P = 0.590) or measures of physical and language abilities. Conclusions: The SADQH-10 is both a valid and reliable observational screening measure of depressive symptoms for stroke patients with aphasia.
Publisher: Informa UK Limited
Date: 13-03-2022
Publisher: Informa UK Limited
Date: 06-06-2019
Publisher: SAGE Publications
Date: 02-2009
Abstract: Background and purpose: We describe our attempts to evaluate the effectiveness of a virtual environment developed to rehabilitate stroke patients in the task of making a hot drink. Methods: Single case studies were performed in 13/138 (9%) stroke patients undergoing rehabilitation in a UK stroke unit. Participants in AB/BA (n = 5) and ABA (n = 2) design studies received 5 one-hour sessions of attention control training (A phase) and 5 one-hour sessions of virtual environment training (B phase). An AB design with random duration of A and B phases (minimum duration of A and B phases 3 and 5 days respectively, with total duration of 3 weeks) was used in 6 participants. Results: Visual inspection of scores across all cases showed a trend towards improvement over time in both real and virtual hot drink making ability in both control and intervention phases. There was no significant difference (Wilcoxon, p 0.05) in the improvements in real and virtual hot drink making ability during all control and intervention phases in the 13 cases. Ceiling effects limited the evaluation of effectiveness in 5 of the 8 cases in which daily performance measures were used. Conclusions: Few people in this setting were suitable for this intervention. The case studies showed no evidence of a strong effect of this intervention, but we had great difficulty in performing single case studies. We conclude that more testing and development of this system is required before it is subjected to rigorous testing of clinical effectiveness.
Publisher: BMJ
Date: 05-2019
DOI: 10.1136/BMJOPEN-2018-023560
Abstract: 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). 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. 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. ACTRN12614000979651.
Publisher: National Institute for Health and Care Research
Date: 09-2022
DOI: 10.3310/RTLH7522
Abstract: People with language problems following stroke (aphasia) benefit from speech and language therapy. Optimising speech and language therapy for aphasia recovery is a research priority. The objectives were to explore patterns and predictors of language and communication recovery, optimum speech and language therapy intervention provision, and whether or not effectiveness varies by participant subgroup or language domain. This research comprised a systematic review, a meta-analysis and a network meta-analysis of in idual participant data. Participant data were collected in research and clinical settings. The intervention under investigation was speech and language therapy for aphasia after stroke. The main outcome measures were absolute changes in language scores from baseline on overall language ability, auditory comprehension, spoken language, reading comprehension, writing and functional communication. Electronic databases were systematically searched, including MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Linguistic and Language Behavior Abstracts and SpeechBITE (searched from inception to 2015). The results were screened for eligibility, and published and unpublished data sets (randomised controlled trials, non-randomised controlled trials, cohort studies, case series, registries) with at least 10 in idual participant data reporting aphasia duration and severity were identified. Existing collaborators and primary researchers named in identified records were invited to contribute electronic data sets. In idual participant data in the public domain were extracted. Data on demographics, speech and language therapy interventions, outcomes and quality criteria were independently extracted by two reviewers, or available as in idual participant data data sets. Meta-analysis and network meta-analysis were used to generate hypotheses. We retrieved 5928 in idual participant data from 174 data sets across 28 countries, comprising 75 electronic (3940 in idual participant data), 47 randomised controlled trial (1778 in idual participant data) and 91 speech and language therapy intervention (2746 in idual participant data) data sets. The median participant age was 63 years (interquartile range 53–72 years). We identified 53 unavailable, but potentially eligible, randomised controlled trials (46 of these appeared to include speech and language therapy). Relevant in idual participant data were filtered into each analysis. Statistically significant predictors of recovery included age (functional communication, in idual participant data: 532, n = 14 randomised controlled trials) and sex (overall language ability, in idual participant data: 482, n = 11 randomised controlled trials functional communication, in idual participant data: 532, n = 14 randomised controlled trials). Older age and being a longer time since aphasia onset predicted poorer recovery. A negative relationship between baseline severity score and change from baseline ( p 0.0001) may reflect the reduced improvement possible from high baseline scores. The frequency, duration, intensity and dosage of speech and language therapy were variously associated with auditory comprehension, naming and functional communication recovery. There were insufficient data to examine spontaneous recovery. The greatest overall gains in language ability [14.95 points (95% confidence interval 8.7 to 21.2 points) on the Western Aphasia Battery-Aphasia Quotient] and functional communication [0.78 points (95% confidence interval 0.48 to 1.1 points) on the Aachen Aphasia Test-Spontaneous Communication] were associated with receiving speech and language therapy 4 to 5 days weekly for auditory comprehension [5.86 points (95% confidence interval 1.6 to 10.0 points) on the Aachen Aphasia Test-Token Test], the greatest gains were associated with receiving speech and language therapy 3 to 4 days weekly. The greatest overall gains in language ability [15.9 points (95% confidence interval 8.0 to 23.6 points) on the Western Aphasia Battery-Aphasia Quotient] and functional communication [0.77 points (95% confidence interval 0.36 to 1.2 points) on the Aachen Aphasia Test-Spontaneous Communication] were associated with speech and language therapy participation from 2 to 4 (and more than 9) hours weekly, whereas the highest auditory comprehension gains [7.3 points (95% confidence interval 4.1 to 10.5 points) on the Aachen Aphasia Test-Token Test] were associated with speech and language therapy participation in excess of 9 hours weekly (with similar gains notes for 4 hours weekly). While clinically similar gains were made alongside different speech and language therapy intensities, the greatest overall gains in language ability [18.37 points (95% confidence interval 10.58 to 26.16 points) on the Western Aphasia Battery-Aphasia Quotient] and auditory comprehension [5.23 points (95% confidence interval 1.51 to 8.95 points) on the Aachen Aphasia Test-Token Test] were associated with 20–50 hours of speech and language therapy. Network meta-analyses on naming and the duration of speech and language therapy interventions across language outcomes were unstable. Relative variance was acceptable ( 30%). Subgroups may benefit from specific interventions. Data sets were graded as being at a low risk of bias but were predominantly based on highly selected research participants, assessments and interventions, thereby limiting generalisability. Frequency, intensity and dosage were associated with language gains from baseline, but varied by domain and subgroup. These exploratory findings require confirmatory study designs to test the hypotheses generated and to develop more tailored speech and language therapy interventions. This study is registered as PROSPERO CRD42018110947. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research Vol. 10, No. 28. See the NIHR Journals Library website for further project information. Funding was also provided by The Tavistock Trust for Aphasia.
Publisher: SAGE Publications
Date: 11-10-2012
Abstract: The aim was to evaluate behavioural therapy as a treatment for low mood in people with aphasia. A randomized controlled trial comparing behavioural therapy plus usual care with a usual care control. Potential participants with aphasia after stroke were screened for the presence of low mood. Those who met the criteria and gave consent were randomly allocated. Participants were recruited from hospital wards, community rehabilitation, speech and language therapy services and stroke groups. Of 511 people with aphasia identified, 105 had low mood and were recruited. Behavioural therapy was offered for up to three months. Outcomes were assessed three and six months after random allocation. Stroke Aphasic Depression Questionnaire, Visual Analog Mood Scales ‘sad’ item, and Visual Analogue Self-Esteem Scale. Participants were aged 29 to 94 years (mean 67.0, SD 13.5) and 66 (63%) were men. Regression analysis showed that at three months, when baseline values and communication impairment were controlled for, group allocation was a significant predictor of the Stroke Aphasic Depression Questionnaire ( P 0.05), visual analogue ‘sad’ ( P = 0.03), and Visual Analogue Self-Esteem Scale ( P 0.01). At six months, group alone was a significant predictor of the Stroke Aphasic Depression Questionnaire ( P 0.05), and remained significant when baseline values were controlled for ( P = 0.02). Mean Stroke Aphasic Depression Questionnaire 10-item hospital version scores decreased from baseline to six months by six points in the intervention group as compared with an increase of 1.9 points in the control group. Behavioural therapy seemed to improve the mood of people with aphasia.
Publisher: Informa UK Limited
Date: 10-08-2023
Publisher: F1000 Research Ltd
Date: 29-06-2020
DOI: 10.12688/AMRCOPENRES.12911.1
Abstract: Background: A transient ischaemic attack (TIA) and minor stroke are medical emergencies and often a warning sign of future strokes if remain untreated. Few studies have investigated the long-term psychosocial effects of TIA and minor stroke. Secondary prevention and medical management are often the primary focus with limited access offered for further psychosocial support. Psychoeducational interventions can provide education and advice to people with physical health conditions and, with suitable tailoring, could be appropriate for people after TIA and minor stroke. This study aims to develop a group psychoeducational intervention for people after TIA and minor stroke and to test whether it is acceptable and feasible. Methods: This mixed-methodology study involves two phases: Phase 1) A qualitative study to determine the content of a suitable intervention Phase 2) A single-centre feasibility randomised controlled trial to evaluate the acceptability of this intervention. The overall study has ethical approval. Stroke survivors have been involved in designing and monitoring the trial. The aim is to recruit 30-40 participants from a Stroke/TIA Service, within 6 months following their diagnosis. Participants will be randomly allocated to either the usual care control group or the intervention group (psychoeducational programme). The programme will consist of six group sessions based on providing education, psychological and social support. The primary outcomes will relate to the feasibility aims of the study. Outcomes will be collected at 3 and 6 months to assess mood, quality of life, knowledge and satisfaction, and resource use. Discussion: There is a need to develop and evaluate effective interventions that enhance the education provided to people after TIA and minor stroke and to promote their psychosocial wellbeing. Findings will indicate the acceptability of the intervention and parameters needed to conduct a definitive trial. Registration: ClinicalTrials.gov ID NCT02550392 registered on 15 September 2015 status: completed.
Publisher: Wiley
Date: 23-01-2023
DOI: 10.1111/HEX.13711
Abstract: 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. 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. 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. 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 in idually tailored, yet provided within a standardized system to ensure accessibility. 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. 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.
Publisher: SAGE Publications
Date: 18-05-2022
DOI: 10.1177/17474930221097477
Abstract: Stroke rehabilitation interventions are routinely personalized to address in iduals’ needs, goals, and challenges based on evidence from aggregated randomized controlled trials (RCT) data and meta-syntheses. In idual participant data (IPD) meta-analyses may better inform the development of precision rehabilitation approaches, quantifying treatment responses while adjusting for confounders and reducing ecological bias. We explored associations between speech and language therapy (SLT) interventions frequency (days/week), intensity (h/week), and dosage (total SLT-hours) and language outcomes for different age, sex, aphasia severity, and chronicity subgroups by undertaking prespecified subgroup network meta-analyses of the RELEASE database. MEDLINE, EMBASE, and trial registrations were systematically searched (inception-Sept2015) for RCTs, including ⩾ 10 IPD on stroke-related aphasia. We extracted demographic, stroke, aphasia, SLT, and risk of bias data. Overall-language ability, auditory comprehension, and functional communication outcomes were standardized. A one-stage, random effects, network meta-analysis approach filtered IPD into a single optimal model, examining SLT regimen and language recovery from baseline to first post-intervention follow-up, adjusting for covariates identified a-priori. Data were dichotomized by age (⩽/ 65 years), aphasia severity (mild–moderate/ moderate–severe based on language outcomes’ median value), chronicity (⩽/ 3 months), and sex subgroups. We reported estimates of means and 95% confidence intervals. Where relative variance was high ( 50%), results were reported for completeness. 959 IPD (25 RCTs) were analyzed. For working-age participants, greatest language gains from baseline occurred alongside moderate to high-intensity SLT (functional communication 3-to-4 h/week overall-language and comprehension 9 h/week) older participants’ greatest gains occurred alongside low-intensity SLT (⩽ 2 h/week) except for auditory comprehension ( 9 h/week). For both age-groups, SLT-frequency and dosage associated with best language gains were similar. Participants ⩽ 3 months post-onset demonstrated greatest overall-language gains for SLT at low intensity/moderate dosage (⩽ 2 SLT-h/week 20-to-50 h) for those 3 months, post-stroke greatest gains were associated with moderate-intensity/high-dosage SLT (3–4 SLT-h/week ⩾ 50 hours). For moderate–severe participants, 4 SLT-days/week conferred the greatest language gains across outcomes, with auditory comprehension gains only observed for ⩾ 4 SLT-days/week mild–moderate participants’ greatest functional communication gains were associated with similar frequency (⩾ 4 SLT-days/week) and greatest overall-language gains with higher frequency SLT (⩾ 6 days/weekly). Males’ greatest gains were associated with SLT of moderate (functional communication 3-to-4 h/weekly) or high intensity (overall-language and auditory comprehension ( 9 h/weekly) compared to females for whom the greatest gains were associated with lower-intensity SLT ( 2 SLT-h/weekly). Consistencies across subgroups were also evident greatest overall-language gains were associated with 20-to-50 SLT-h in total auditory comprehension gains were generally observed when SLT 9 h over ⩾ 4 days/week. We observed a treatment response in most subgroups’ overall-language, auditory comprehension, and functional communication language gains. For some, the maximum treatment response varied in association with different SLT-frequency, intensity, and dosage. Where differences were observed, working-aged, chronic, mild–moderate, and male subgroups experienced their greatest language gains alongside high-frequency/intensity SLT. In contrast, older, moderate–severely impaired, and female subgroups within 3 months of aphasia onset made their greatest gains for lower-intensity SLT. The acceptability, clinical, and cost effectiveness of precision aphasia rehabilitation approaches based on age, sex, aphasia severity, and chronicity should be evaluated in future clinical RCTs.
Publisher: BMJ
Date: 10-2017
DOI: 10.1136/BMJOPEN-2017-018309
Abstract: Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers’ needs are considered and addressed despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT). Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life. Favourable ethical opinion was provided by East Midlands – Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences. ISRCTN15643456 Pre-results.
Publisher: Informa UK Limited
Date: 11-05-2022
DOI: 10.1080/09602011.2022.2070506
Abstract: 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
Publisher: Wiley
Date: 05-11-2014
DOI: 10.1111/BJHP.12123
Abstract: Motivation is identified as a key antecedent of self-regulated behaviour, such as eating fruit and vegetables. However, inaccurate measurement of this construct may lead to poor prediction of behaviour and inflate the impact of post-motivational factors, such as planning, in models of health behaviour. This study explored the properties of a newly identified measure of motivation, termed behavioural resolve (Rhodes & Horne, 2013, Psychol. Sport Exerc., 14, 455-460), in relation to intention, planning, and fruit and vegetable intake (FVI). Prospective self-report survey. University students living in the United Kingdom completed two online surveys. The first assessed demographic and predictor variables (intention, behavioural resolve, action planning, and coping planning). The second, completed approximately 2 weeks later, measured average daily FVI and perceived experience of obstacles to FVI. At Time 1, there were 195 respondents, with 139 providing follow-up data. All predictor variables were significantly correlated with FVI. Two independent multiple hierarchical regression analyses revealed that both intention and behavioural resolve were significant predictors of FVI, but behavioural resolve explained greater FVI variance (40.1%) than intention (36.4%). Furthermore, action planning showed incremental predictive utility over intention, but not behavioural resolve, in predicting FVI. The results indicated that motivation is an important determinant of FVI for students, with behavioural resolve demonstrating advantages over intention as a measure of this domain and a predictor of FVI behaviour.
Publisher: Informa UK Limited
Date: 02-01-2022
Publisher: Informa UK Limited
Date: 08-10-2021
Publisher: Informa UK Limited
Date: 30-09-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2022
DOI: 10.1161/STROKEAHA.121.035216
Abstract: Optimizing speech and language therapy (SLT) regimens for maximal aphasia recovery is a clinical research priority. We examined associations between SLT intensity (hours/week), dosage (total hours), frequency (days/week), duration (weeks), delivery (face to face, computer supported, in idual tailoring, and home practice), content, and language outcomes for people with aphasia. Databases including MEDLINE and Embase were searched (inception to September 2015). Published, unpublished, and emerging trials including SLT and ≥10 in idual participant data on aphasia, language outcomes, and time post-onset were selected. Patient-level data on stroke, language, SLT, and trial risk of bias were independently extracted. Outcome measurement scores were standardized. A statistical inferencing, one-stage, random effects, network meta-analysis approach filtered in idual participant data into an optimal model examining SLT regimen for overall language, auditory comprehension, naming, and functional communication pre-post intervention gains, adjusting for a priori–defined covariates (age, sex, time poststroke, and baseline aphasia severity), reporting estimates of mean change scores (95% CI). Data from 959 in idual participant data (25 trials) were included. Greatest gains in overall language and comprehension were associated with to 50 hours SLT dosage (18.37 [10.58–26.16] Western Aphasia Battery–Aphasia Quotient 5.23 [1.51–8.95] Aachen Aphasia Test–Token Test). Greatest clinical overall language, functional communication, and comprehension gains were associated with 2 to 4 and 9+ SLT hours/week. Greatest clinical gains were associated with frequent SLT for overall language, functional communication (3–5+ days/week), and comprehension (4–5 days/week). Evidence of comprehension gains was absent for SLT ≤20 hours, hours/week, and ≤3 days/week. Mixed receptive-expressive therapy, functionally tailored, with prescribed home practice was associated with the greatest overall gains. Relative variance was %. Risk of trial bias was low to moderate low for meta-biases. Greatest language recovery was associated with frequent, functionally tailored, receptive-expressive SLT, with prescribed home practice at a greater intensity and duration than reports of usual clinical services internationally. These exploratory findings suggest critical therapeutic ranges, informing hypothesis-testing trials and tailoring of clinical services. URL: www.crd.york.ac.uk/PROSPERO/ Unique identifier: CRD42018110947.
Publisher: National Institute for Health and Care Research
Date: 09-2019
DOI: 10.3310/HTA23470
Abstract: There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. 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. Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. Acute and community stroke services in three sites in England. 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. 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. 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. 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. 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 s le size of between 580 and 623 participants would be needed for a definitive trial. Target recruitment was not achieved, although we identified methods to improve recruitment. 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. Current Controlled Trials ISRCTN12715175. 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.
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Shirley Thomas.