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.

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

Pilot and Feasibility Studies ◽

10.1186/s40814-016-0072-0 ◽

2016 ◽

Vol 2 (1) ◽

Cited By ~ 7

Author(s):

Shirley A. Thomas ◽

Elizabeth Coates ◽

Roshan das Nair ◽

Nadina B. Lincoln ◽

Cindy Cooper ◽

...

Keyword(s):

Study Protocol ◽

Psychological Intervention ◽

Pilot Trial ◽

Behavioural Activation ◽

Post Stroke ◽

Post Stroke Depression ◽

Activation Therapy ◽

Randomised Controlled

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A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

Health Technology Assessment ◽

10.3310/hta23270 ◽

2019 ◽

Vol 23 (27) ◽

pp. 1-166 ◽

Cited By ~ 3

Author(s):

Hilary Gunn ◽

Jackie Andrade ◽

Lorna Paul ◽

Linda Miller ◽

Siobhan Creanor ◽

...

Keyword(s):

Usual Care ◽

Intervention Group ◽

Health Technology ◽

Feasibility Trial ◽

Completion Rates ◽

Economic Data ◽

Definitive Trial ◽

Secondary Progressive ◽

Edss Score ◽

Randomised Controlled

Background Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility. Objective This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial. Design Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework. Setting Four sites across the UK. Participants Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months. Interventions Intervention – manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator – usual care alone. Main outcome measures Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data. Results A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0–6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason (n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 –7.7 [95% confidence interval (CI) –17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI –7.8 to 9) and MSIS-29vs2 psychological –0.4 (95% CI –9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0–93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted. Conclusions The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries. Future work Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted. Trial registration Current Controlled Trials ISRCTN13587999. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.

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Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

Health Technology Assessment ◽

10.3310/hta23570 ◽

2019 ◽

Vol 23 (57) ◽

pp. 1-130

Author(s):

Sarah Hewlett ◽

Celia Almeida ◽

Nicholas Ambler ◽

Peter S Blair ◽

Ernest Choy ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Usual Care ◽

Self Efficacy ◽

Clinical Effectiveness ◽

Cost Effective ◽

Health Technology ◽

Mean Difference ◽

Cognitive Behavioural ◽

Fatigue Severity ◽

Group Cbt

Background Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive–behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. Objectives To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive–behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors’ experiences of the RAFT programme. Design A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. Setting Seven hospital rheumatology units in England and Wales. Participants Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. Interventions RAFT – group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care – brief discussion of a RA fatigue self-management booklet with the research nurse. Main outcome measures Primary – fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary – fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. Results A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (–1.36 units; p < 0.001) and the control interventions (–0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference –0.59 units, 95% confidence interval (CI) –1.11 to –0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (–0.49 units, 95% CI –0.83 to –0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference –3.42 units, 95% CI –6.44 to – 0.39 units, p = 0.03; living with fatigue: adjusted mean difference –1.19 units, 95% CI –2.17 to –0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference –0.91 units, 95% CI –1.58 to –0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI –£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI –0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28–35% at the National Institute for Health and Care Excellence’s thresholds of £20,000–30,000 per QALY. Tutors felt that the RAFT programme’s CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors’ wider clinical practice. Limitations Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. Conclusions The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. Future work Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. Trial registration Current Controlled Trials ISRCTN52709998. 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. 57. See the NIHR Journals Library website for further project information.

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TASC (Telehealth After Stroke Care): A Study Protocol for a Randomized Controlled Feasibility Trial of Telehealth-enabled Multidisciplinary Stroke Care in an Underserved Urban Setting

10.21203/rs.3.rs-325391/v1 ◽

2021 ◽

Author(s):

Imama A. Naqvi ◽

Ying Kuen Cheung ◽

Kevin H Strobino ◽

Hanlin Li ◽

Sarah E Tom ◽

...

Keyword(s):

Acute Stroke ◽

Usual Care ◽

Multidisciplinary Team ◽

Stroke Care ◽

Urban Setting ◽

Feasibility Trial ◽

Additional Patient ◽

Team Approach ◽

Post Stroke ◽

Multidisciplinary Team Approach

Abstract BackgroundHypertension is the most important modifiable risk factor for recurrent stroke, and blood pressure (BP) reduction is associated with decreased risk of stroke recurrence. However, hypertension remains poorly controlled in many stroke survivors. Black and Hispanic patients have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access to care contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) is a telehealth intervention that integrates Remote BP Monitoring (RBPM) including nursing telephone support, tailored BP infographics and telehealth video visits with a multidisciplinary team approach including pharmacy to improve post-stroke care and reduce stroke disparities.MethodsIn this pilot trial, 50 acute stroke patients with hypertension will be screened for inclusion prior to hospital discharge and randomized to usual care or TASC. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. In addition to these usual care visits, TASC intervention patients will see a pharmacist at 4 and 8 weeks and will be enrolled in RBPM consisting of home BP monitoring with interval calls by a centralized team of telehealth nurses. As part of RBPM, TASC patients will be provided with a home BP monitoring device and electronic tablet that wirelessly transmits home BP data to the electronic health record. They will also receive tailored BP infographics that help explain their BP readings. The primary outcome will be within-patient change in BP from baseline to 3 months after discharge. Secondary outcomes will be medication adherence self-efficacy and satisfaction with post-stroke telehealth, both measured at 3-months. Additional patient reported outcomes will include depression, cognitive function, and socioeconomic determinants. Multidisciplinary team competency and fidelity measures will also be assessed.ConclusionsIntegrated team-based interventions may improve BP control and reduce racial/ethnic disparities in post-stroke care. TASC is a post-acute stroke care model that is novel in providing RBPM with tailored infographics, and a multidisciplinary team approach including pharmacy. Our pilot will determine if such an approach is feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.Trial Registration: ClinicalTrials.gov NCT04640519

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Early Symptom Measurement of Post‐Stroke Depression

PsycTESTS Dataset ◽

10.1037/t72564-000 ◽

2016 ◽

Author(s):

Jufang Li ◽

Linda Denise Oakley ◽

Roger L. Brown ◽

Yun Li ◽

Maiyun Ye ◽

...

Keyword(s):

Early Symptom ◽

Post Stroke ◽

Post Stroke Depression ◽

Symptom Measurement

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Early Symptom Measurement of Post‐Stroke Depression--Short Version

PsycTESTS Dataset ◽

10.1037/t72531-000 ◽

2019 ◽

Author(s):

Jufang Li ◽

Yun Li ◽

Ping Li ◽

Maiyun Ye

Keyword(s):

Short Version ◽

Early Symptom ◽

Post Stroke ◽

Post Stroke Depression ◽

Symptom Measurement

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Therapy of post-stroke depression – a systematic review

Die Psychiatrie ◽

10.1055/s-0038-1670863 ◽

2013 ◽

Vol 10 (02) ◽

pp. 108-129 ◽

Cited By ~ 1

Author(s):

W. Gaebel ◽

W. Wannagat ◽

J. Zielasek

Keyword(s):

Systematic Review ◽

Large Scale ◽

Repetitive Transcranial Magnetic Stimulation ◽

Placebo Control ◽

Post Stroke ◽

Pharmacological Studies ◽

Post Stroke Depression ◽

Control Procedures ◽

Antidepressant Pharmacotherapy

SummaryWe performed a systematic review of randomized placebo-controlled pharmacological and non-pharmacological trials for the therapy and prevention of post-stroke depression that have been published between 1980 and 2011. We initially identified 2 260 records of which 28 studies were finally included into this review. A meta-analytic approach was hampered by considerable differences regarding the kinds of therapeutic regimens and the study durations. Modest effects favoring treatment of post-stroke depression could be found for pharmacological treatment as well as repetitive transcranial magnetic stimulation. For the prevention of post-stroke depression, antidepressant pharmacotherapy showed promising results. However, large-scale studies with better standardized study populations, optimized placebo control procedures in non-pharmacological studies, and replication in larger follow-up studies are still necessary to find the optimal therapeutic regimens to prevent and treat post-stroke depression.

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