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Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT.
Health Technol Assess. 2019 09; 23(47):1-176.HT

Abstract

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.

Authors+Show Affiliations

School of Medicine, University of Nottingham, Nottingham, UK.School of Health Sciences, University of Nottingham, Nottingham, UK.School of Medicine, University of Nottingham, Nottingham, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.School of Medicine, University of Nottingham, Nottingham, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.School of Medicine, University of Nottingham, Nottingham, UK.School of Health Sciences, University of Nottingham, Nottingham, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.School of Medicine, University of Nottingham, Nottingham, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31524133

Citation

Thomas, Shirley A., et al. "Behavioural Activation Therapy for Post-stroke Depression: the BEADS Feasibility RCT." Health Technology Assessment (Winchester, England), vol. 23, no. 47, 2019, pp. 1-176.
Thomas SA, Drummond AE, Lincoln NB, et al. Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT. Health Technol Assess. 2019;23(47):1-176.
Thomas, S. A., Drummond, A. E., Lincoln, N. B., Palmer, R. L., das Nair, R., Latimer, N. R., Hackney, G. L., Mandefield, L., Walters, S. J., Hatton, R. D., Cooper, C. L., Chater, T. F., England, T. J., Callaghan, P., Coates, E., Sutherland, K. E., Eshtan, S. J., & Topcu, G. (2019). Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT. Health Technology Assessment (Winchester, England), 23(47), 1-176. https://doi.org/10.3310/hta23470
Thomas SA, et al. Behavioural Activation Therapy for Post-stroke Depression: the BEADS Feasibility RCT. Health Technol Assess. 2019;23(47):1-176. PubMed PMID: 31524133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT. AU - Thomas,Shirley A, AU - Drummond,Avril Er, AU - Lincoln,Nadina B, AU - Palmer,Rebecca L, AU - das Nair,Roshan, AU - Latimer,Nicholas R, AU - Hackney,Gemma L, AU - Mandefield,Laura, AU - Walters,Stephen J, AU - Hatton,Rachael D, AU - Cooper,Cindy L, AU - Chater,Timothy F, AU - England,Timothy J, AU - Callaghan,Patrick, AU - Coates,Elizabeth, AU - Sutherland,Katie E, AU - Eshtan,Sarah Jacob, AU - Topcu,Gogem, PY - 2019/9/17/entrez PY - 2019/9/17/pubmed PY - 2020/10/3/medline KW - COST–BENEFIT ANALYSIS KW - DEPRESSION KW - PSYCHOTHERAPY KW - RESEARCH DESIGN KW - STROKE SP - 1 EP - 176 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 23 IS - 47 N2 - 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. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/31524133/Behavioural_activation_therapy_for_post_stroke_depression:_the_BEADS_feasibility_RCT_ L2 - https://doi.org/10.3310/hta23470 DB - PRIME DP - Unbound Medicine ER -