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

Thomas, Shirley; Coates, Elizabeth; Nair, Roshan das; Lincoln, Nadina B.; Cooper, Cindy; Palmer, Rebecca; Walters, Stephen J.; Latimer, Nicholas; England, Timothy J.; Mandefield, Laura; Chater, Tim; Callaghan, Patrick; Drummond, Avril

doi:10.1186/s40814-016-0072-0

Cited by 19 publications

(10 citation statements)

References 56 publications

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“…Participants who did not have moderate or severe language problems were asked to complete the standard version of the EQ-5D-5L as well as an amended (and as yet unvalidated) accessible version (based on pictures). 57 Participants who had moderate to severe language problems were asked to complete the accessible version of the EQ-5D-5L. In addition, for participants who had carers, the carer was asked to complete a standard EQ-5D-5L by proxy.…”

Section: Discussionmentioning

confidence: 99%

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

Thomas

Drummond

Lincoln

et al. 2019

Health Technol Assess

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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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Section: Discussionmentioning

confidence: 99%

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

Thomas

Drummond

Lincoln

et al. 2019

Health Technol Assess

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“…However, these trials involved people early after stroke and excluded those with severe communication or cognitive problems. The CALM (Communication and Low Mood) trial27 of behavioural therapy demonstrated improved mood in patients with stroke with aphasia, and a feasibility study of behavioural activation is now under way using a broader sample of people with depression 3–60 months poststroke 28. A study of cognitive behavioural therapy (CBT) for poststroke depression demonstrated no benefits over usual care or an attention control; however, the sample size was small 29…”

Section: Introductionmentioning

confidence: 99%

HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care compared with usual care to increase psychological well-being in people following a stroke

et al. 2019

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IntroductionPeople often experience distress following stroke due to fundamental challenges to their identity.ObjectivesTo evaluate (1) the acceptability of ‘HeART of Stroke’ (HoS), a community-based arts and health group intervention, to increase psychological well-being; and (2) the feasibility of a definitive randomised controlled trial (RCT).DesignTwo-centre, 24-month, parallel-arm RCT with qualitative and economic components. Randomisation was stratified by centre and stroke severity. Participant blinding was not possible. Outcome assessment blinding was attempted.SettingCommunity.ParticipantsCommunity-dwelling adults ≤2 years poststroke recruited via hospital clinical teams/databases or community stroke/rehabilitation teams.InterventionsArtist-facilitated arts and health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC.OutcomesThe outcomes were self-reported measures of well-being, mood, capability, health-related quality of life, self-esteem and self-concept (baseline and 5 months postrandomisation). Key feasibility parameters were gathered, data collection methods were piloted, and participant interviews (n=24) explored the acceptability of the intervention and study processes.ResultsDespite a low recruitment rate (14%; 95% CI 11% to 18%), 88% of the recruitment target was met, with 29 participants randomised to HoS and 27 to UC (57% male; mean (SD) age=70 (12.1) years; time since stroke=9 (6.1) months). Follow-up data were available for 47 of 56 (84%; 95% CI 72% to 91%). Completion rates for a study-specific resource use questionnaire were 79% and 68% (National Health Service and societal perspectives). Five people declined HoS postrandomisation; of the remaining 24 who attended, 83% attended ≥6 sessions. Preliminary effect sizes for candidate primary outcomes were in the direction of benefit for the HoS arm. Participants found study processes acceptable. The intervention cost an estimated £456 per person and was well-received (no intervention-related serious adverse events were reported).ConclusionsFindings from this first community-based study of an arts and health intervention for people poststroke suggest a definitive RCT is feasible. Recruitment methods will be revised.Trial registration numberISRCTN99728983.

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“…BA has shown strong effects both individually (d = 0.78) and in group (d = 0.74) settings in the non-ABI population [25,37,38] as well as preliminary support (d = 0.27 to 0.71) in one-to-one therapy in stroke [34] but this is the rst group BA evaluation, of which we are aware, in ABI. There are clear economic advantages to groups compared with individual therapy [39].…”

Section: Introductionmentioning

confidence: 81%

“…Reduced activity engagement is an important factor contributing to the elevated rates of depression and low mood in ABI [28][29][30][31][32] and thus interventions aimed at improving activity engagement are well-suited toward this population. Promising work examining BA in the speci c context of stroke is already underway [33,34]. In a re-analysis of randomised controlled trial data, Bombardier and colleagues [35] concluded that environmental rewards from daily activities correlated with decreased depression, suggesting the BA-style interventions may be appropriate in TBI as well.…”

Section: Introductionmentioning

confidence: 99%

Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A randomised controlled pilot feasibility trial for low mood in acquired brain injury

Kusec

Murphy

Peers

et al. 2020

Preprint

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Abstract Background: Acquired brain injury (ABI) affects approximately 79.3 million individuals annually and is linked with elevated rates of depression and low mood. Existing methods for treating depression in ABI have shown mixed efficacy. Behavioural Activation (BA) is a potentially promising intervention. Its premise is that individuals with low mood avoid planning and engaging in activities due to low expectations of a positive outcome. Consequently, their exposure to positive reinforcement is reduced, exacerbating low mood. BA aims to break this cycle by encouraging activity planning and engagement. It is unknown whether cognitive demands of traditional BA may undermine efficacy in ABI. Here we assess the feasibility and acceptability of two groups designed to increase activity engagement. In the Activity Planning Group (traditional BA) the importance of meaningful and positive activity will be discussed and participants encouraged to plan/engage in activities in everyday life. The Activity Engagement Group (experiential BA) instead focuses on engagement in positive experiences (crafts, games, discussion) within the group. The primary aims are to evaluate the feasibility and acceptability of the two groups in ABI. A secondary aim is to explore relative efficacy of the groups compared to an equivalent period of waitlist controls. Method: This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs. waitlist controls. Adults (≥18 years) will be recruited from local ABI services and randomised to condition. Feasibility and acceptability will be assessed via recruitment, retention, attendance, and participant feedback. Groups will be compared (pre- and post-intervention and 1 month follow-up) by assessing self-reported activity engagement. Secondary outcomes include self-report measures of depression, anxiety, post-traumatic distress related to the ABI, motivation, participation, and sense of control over one’s life. Ethics and Dissemination: The trial has been approved by the Health Research Authority of the NHS in the UK (East of England – Cambridge Central, REF: 18/EE/0305). Results will inform future research on interventions for mood in ABI and be disseminated broadly via peer-reviewed journals, conference presentations, and social media.

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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

Cited by 19 publications

References 56 publications

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

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

HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care compared with usual care to increase psychological well-being in people following a stroke

Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): A randomised controlled pilot feasibility trial for low mood in acquired brain injury

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