CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

BACKGROUND: Depression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management. OBJECTIVES: To establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care. DESIGN: A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1 : 1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible. SETTING: Sixty-nine general practices in the north of England. PARTICIPANTS: A total of 485 participants aged ≥ 65 years with major depressive disorder. INTERVENTIONS: A low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care. MAIN OUTCOME MEASURES: The primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor-Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months. RESULTS: In total, 485 participants were randomised (collaborative care, n = 249; usual care, n = 236), with 390 participants (80%: collaborative care, 75%; usual care, 86%) followed up at 4 months, 358 participants (74%: collaborative care, 70%; usual care, 78%) followed up at 12 months and 344 participants (71%: collaborative care, 67%; usual care, 75%) followed up at 18 months. A total of 415 participants were included in primary analysis (collaborative care, n = 198; usual care, n = 217), which revealed a statistically significant effect in favour of collaborative care at the primary end point at 4 months [8.98 vs. 10.90 score points, mean difference 1.92 score points, 95% confidence interval (CI) 0.85 to 2.99 score points; p < 0.001], equivalent to a standard effect size of 0.34. However, treatment differences were not maintained in the longer term (at 12 months: 0.19 score points, 95% CI -0.92 to 1.29 score points; p = 0.741; at 18 months: < 0.01 score points, 95% CI -1.12 to 1.12 score points; p = 0.997). The study recorded details of all serious adverse events (SAEs), which consisted of 'unscheduled hospitalisation', 'other medically important condition' and 'death'. No SAEs were related to the intervention. Collaborative care showed a small but non-significant increase in quality-adjusted life-years (QALYs) over the 18-month period, with a higher cost. Overall, the mean cost per incremental QALY for collaborative care compared with usual care was £26,016; however, for participants attending six or more sessions, collaborative care appears to represent better value for money (£9876/QALY). LIMITATIONS: Study limitations are identified at different stages: design (blinding unfeasible, potential contamination), process (relatively low overall consent rate, differential attrition/retention rates) and analysis (no baseline health-care resource cost or secondary/social care data). CONCLUSION: Collaborative care was effective for older people with case-level depression across a range of outcomes in the short term though the reduction in depression severity was not maintained over the longer term of 12 or 18 months. Participants who received six or more sessions of collaborative care did benefit substantially more than those who received fewer treatment sessions but this difference was not statistically significant. FUTURE WORK RECOMMENDATIONS: Recommendations for future research include investigating the longer-term effect of the intervention. Depression is a recurrent disorder and it would be useful to assess its impact on relapse and the prevention of future case-level depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45842879. 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. 21, No. 67. See the NIHR Journals Library website for further project information.

CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

BACKGROUND: 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. OBJECTIVES: 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. DESIGN: 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. SETTING: Thirty-two general practitioner (GP) practices in the north of England. PARTICIPANTS: A total of 705 participants aged ≥ 75 years during the pilot phase and ≥ 65 years during the main trial with subthreshold depression. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: In total, 705 participants were randomised (collaborative care n = 344, usual care n = 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). CONCLUSIONS: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02202951. 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. 21, No. 8. See the NIHR Journals Library website for further project information.

Diagnostic accuracy of the Whooley questions for the identification of depression: a diagnostic meta-analysis.

OBJECTIVES: To determine the diagnostic accuracy of the Whooley questions in the identification of depression; and, to examine the effect of an additional 'help' question. DESIGN: Systematic review with random effects bivariate diagnostic meta-analysis. Search strategies included electronic databases, examination of reference lists, and forward citation searches. INCLUSION CRITERIA: Studies were included that provided sufficient data to calculate the diagnostic accuracy of the Whooley questions against a gold standard diagnosis of major depression. DATA EXTRACTION: Descriptive information, methodological quality criteria, and 2 × 2 contingency tables were extracted. RESULTS: Ten studies met inclusion criteria. Pooled sensitivity was 0.95 (95% CI 0.88 to 0.97) and pooled specificity was 0.65 (95% CI 0.56 to 0.74). Heterogeneity was low (I(2)=24.1%). Primary care subgroup analysis gave broadly similar results. Four of the ten studies provided information on the effect of an additional help question. The addition of this question did not consistently improve specificity while retaining high sensitivity as reported in the original validation study. CONCLUSIONS: The two-item Whooley questions have high sensitivity and modest specificity in the detection of depression. The current evidence for the use of an additional help question is not consistent and there is, as yet, insufficient data to recommend its use for screening or case finding. TRIAL REGISTRATION NUMBER: CRD42014009695.

Revealing hidden depression in older people: a qualitative study within a randomised controlled trial.

BACKGROUND: The prevalence of depressive symptoms in older people may be as high as 20 %. Depression in older people is associated with loss, loneliness and physical co-morbidities; it is known to be under-diagnosed and under-treated. Older people may find it difficult to speak to their GPs about low mood, and GPs may avoid identifying depression due to limited consultation time and referral options for older patients. METHODS: A nested qualitative study in a randomised controlled trial for older people with moderate to severe depression: the CASPER Plus Trial (Collaborative Care for Screen Positive Elders). We interviewed GPs, case managers (CM) and patient participants to explore perspectives and experiences of delivering and receiving a psychosocial intervention, developed specifically for older adults in primary care, within a collaborative care framework. Transcripts were analysed thematically using principles of constant comparison. RESULTS: Thirty three interviews were conducted and, across the three data-sets, four main themes were identified: revealing hidden depression, reducing the 'blind spots', opportunity to talk outside the primary care consultation and 'moving on' from depression. CONCLUSIONS: Depression in older people is commonly hidden, and may coexist with physical conditions that are prioritised by both patients and GPs. Being invited to participate in a trial about depression may allow older people to disclose their feelings, name the problem, and seek help. Offering older people an opportunity to talk outside the primary care consultation is valued by patients and GPs. A psychosocial intervention delivered by a case manager in the primary care setting may fill the gap in the care of older people with depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45842879 .

CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial.

BACKGROUND: Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option. METHODS/DESIGN: CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health-related quality of life using the SF-12 and EQ-5D and will examine cost-consequences of collaborative care. A qualitative process evaluation will be undertaken to explore acceptability, gauge the extent to which the intervention is implemented and to explore sustainability beyond the clinical trial. DISCUSSION: Results will add to existing evidence and a positive outcome may lead to the commissioning of this model of service in primary care. TRIAL REGISTRATION: ISRCTN45842879 (24 July 2012).