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

BackgroundEfforts 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.ObjectivesTo 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.DesignA 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.SettingThirty-two general practitioner (GP) practices in the north of England.ParticipantsA total of 705 participants aged ≥ 75 years during the pilot phase and ≥ 65 years during the main trial with subthreshold depression.InterventionsParticipants 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 measuresThe 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.ResultsIn 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).ConclusionsCollaborative 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 registrationCurrent Controlled Trials ISRCTN02202951.FundingThis 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.

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

“…50 The effect size is consistent with findings from systematic reviews of collaborative care, as summarised in a recent Cochrane review, 22 and is also of the same order of magnitude as that seen in UK trials of collaborative care for working-age adults, such as those observed in the recently published CADET 69 and also in the recently completed CASPER trial for older people with lower-severity depression. 29,30 The CASPER plus trial also showed benefits across a range of secondary outcomes, and it was notable that there were improvements in anxiety symptoms, somatoform symptoms and quality of life (mental domain as measured by the SF-12). These benefits were seen in the short term (4 months) and were also sustained at 12 months for secondary outcomes (but not for the outcome of depression severity).…”

“…To detect a minimum standard effect size of 0.35 (aligning with the US IMPACT study 16 and our previous CASPER trial 29,30 ) with 80% power and a two-sided 5% significance level, 260 patients (130 per arm) would be required. Although this is an individually randomised trial, there may be potential clustering at the level of each collaborative care case manager, and hence the sample size was inflated to account for this.…”

Economic Evaluations of Public Health Interventions to Improve Mental Health and Prevent Suicidal Thoughts and Behaviours: A Systematic Literature Review

“…Seven studies (Buntrock et al 2017;Fernandez et al 2018;Ophuis et al 2018;Ride et al 2016;Uegaki et al 2011;van den Berg et al 2011;van Oostrom et al 2010) evaluated interventions delivered to the general population, mainly adults over 18 years old. Four interventions were delivered at primary and maternity care centers (Fernandez et al 2018;Ophuis et al 2018;Ride et al 2016;van den Berg et al 2011), two were delivered in the workplace (Uegaki et al 2011; van Oostrom et al (Coulton et al 2015;Lewis et al 2017). Six studies (Anderson et al 2014;Lee et al 2017;Lynch et al 2005;Mihalopoulos et al 2012;Philipsson et al 2013;Stallard et al 2015) evaluated seven interventions targeting children and adolescents under 18 years.…”

“…Four studies (Anderson et al 2014;Buntrock et al 2017;Lewis et al 2017;van Oostrom et al 2010) aimed to promote mental health were considered to be of high quality, but none of the studies that evaluated suicide preventive interventions were considered high quality. Of the highquality studies, all evaluated interventions were indicated.…”

“…The interventions were mainly CBT based and delivered in the community and workplace for sick employees to return to work. Two studies adopted a societal perspective (Buntrock et al 2017;van Oostrom et al 2010), the other used a health and social care sector perspective (Anderson et al 2014;Lewis et al 2017). Two interventions (Buntrock et al 2017;Lewis et al 2017) were cost-effective.…”