title: CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.
abstract: Efforts to reduce the burden of illness and personal suffering associated with depression in older adults have focused on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/subthreshold depression, but these patients also suffer significant impairments in their quality of life and level of functioning. There is currently no clear evidence-based guidance regarding treatment for this patient group.
  
  
  
  To establish the clinical effectiveness and cost-effectiveness of a low-intensity intervention of collaborative care for primary care older adults who screened positive for subthreshold depression.
  
  
  
  A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected.
  
  
  
  Thirty-two general practitioner (GP) practices in the north of England.
  
  
  
  A total of 705 participants aged ≥ 75 years during the pilot phase and ≥ 65 years during the main trial with subthreshold depression.
  
  
  
  Participants in the intervention group received a low-intensity intervention of collaborative care, which included behavioural activation delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual GP care. Control-arm participants received only usual GP care.
  
  
  
  The primary outcome measure was a self-reported measure of depression severity, the Patient Health Questionnaire-9 items PHQ-9 score at 4 months post randomisation. Secondary outcome measures included the European Quality of Life-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder seven-item scale, Connor-Davidson Resilience Scale two-item version, a medication questionnaire and objective data. Participants were followed up for 12 months.
  
  
  
  In total, 705 participants were randomised (collaborative caren= 344, usual caren= 361), with 586 participants (83%; collaborative care 76%, usual care 90%) followed up at 4 months and 519 participants (74%; collaborative care 68%, usual care 79%) followed up at 12 months. Attrition was markedly greater in the collaborative care arm. Model estimates at the primary end point of 4 months revealed a statistically significant effect in favour of collaborative care compared with usual care [mean difference 1.31 score points, 95% confidence interval (CI) 0.67 to 1.95 score points;p< 0.001]. The difference equates to a standard effect size of 0.30, for which the trial was powered. Treatment differences measured by the PHQ-9 were maintained at 12 months' follow-up (mean difference 1.33 score points, 95% CI 0.55 to 2.10 score points;p= 0.001). Base-case cost-effectiveness analysis found that the incremental cost-effectiveness ratio was £9633 per quality-adjusted life-year (QALY). On average, participants allocated to collaborative care displayed significantly higher QALYs than those allocated to the control group (annual difference in adjusted QALYs of 0.044, 95% bias-corrected CI 0.015 to 0.072;p= 0.003).
  
  
  
  Collaborative care has been shown to be clinically effective and cost-effective for older adults with subthreshold depression and to reduce the proportion of people who go on to develop case-level depression at 12 months. This intervention could feasibly be delivered in the NHS at an acceptable cost-benefit ratio. Important future work would include investigating the longer-term effect of collaborative care on the CASPER population, which could be conducted by introducing an extension to follow-up, and investigating the impact of collaborative care on managing multimorbidities in people with subthreshold depression.
  
  
  
  Current Controlled Trials ISRCTN02202951.
  
  
  
  This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 8. See the NIHR Journals Library website for further project information.
authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.lastname: Lewis
authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.lastname: Adamson
authors.affiliation: Leeds and York Partnership NHS Foundation Trust, Leeds, UK.
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authors.lastname: Atherton
authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Northumberland, Tyne and Wear NHS Foundation Trust, NIHR Clinical Research Network (Mental Health) North East and North Cumbria, Newcastle upon Tyne, UK.
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authors.affiliation: Primary Care Mental Health Service, Leeds Community Healthcare NHS Trust, Leeds, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.|Hull York Medical School, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Tees, Esk and Wear Valleys NHS Foundation Trust, NIHR Clinical Research Network North East and North Cumbria, Research and Development Department, Middlesbrough, UK.
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authors.affiliation: Leeds and York Partnership NHS Foundation Trust, Leeds, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Leeds and York Partnership NHS Foundation Trust, Leeds, UK.
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authors.affiliation: Northumberland, Tyne and Wear NHS Foundation Trust, NIHR Clinical Research Network (Mental Health) North East and North Cumbria, Newcastle upon Tyne, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.|Hull York Medical School, University of York, York, UK.
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authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Leeds and York Partnership NHS Foundation Trust, Leeds, UK.
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authors.lastname: Pasterfield
authors.affiliation: Department of Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.
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authors.lastname: Richards
authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Gemma
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authors.lastname: Traviss-Turner
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Dominic
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.
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authors.affiliation: Department of Health Sciences, University of York, York, UK.|Hull York Medical School, University of York, York, UK.
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mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019090:Case Management / Q000191:economics / Q000458:organization & administration*; D000071959:Case Managers / Q000458:organization & administration; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder; D005260:Female; D058006:General Practice / Q000458:organization & administration*; D006304:Health Status; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care; D011320:Primary Health Care / Q000458:organization & administration*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D012959:Socioeconomic Factors; D013222:State Medicine / Q000191:economics; D006113:United Kingdom