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 signifi...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2017-02-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta21080 |
| _version_ | 1828401110917840896 |
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| author | Helen Lewis Joy Adamson Katie Atherton Della Bailey Jacqueline Birtwistle Katharine Bosanquet Emily Clare Jaime Delgadillo David Ekers Deborah Foster Rhian Gabe Samantha Gascoyne Lesley Haley Rebecca Hargate Catherine Hewitt John Holmes Ada Keding Amanda Lilley-Kelly Jahnese Maya Dean McMillan Shaista Meer Jodi Meredith Natasha Mitchell Sarah Nutbrown Karen Overend Madeline Pasterfield David Richards Karen Spilsbury David Torgerson Gemma Traviss-Turner Dominic Trépel Rebecca Woodhouse Friederike Ziegler Simon Gilbody |
| author_facet | Helen Lewis Joy Adamson Katie Atherton Della Bailey Jacqueline Birtwistle Katharine Bosanquet Emily Clare Jaime Delgadillo David Ekers Deborah Foster Rhian Gabe Samantha Gascoyne Lesley Haley Rebecca Hargate Catherine Hewitt John Holmes Ada Keding Amanda Lilley-Kelly Jahnese Maya Dean McMillan Shaista Meer Jodi Meredith Natasha Mitchell Sarah Nutbrown Karen Overend Madeline Pasterfield David Richards Karen Spilsbury David Torgerson Gemma Traviss-Turner Dominic Trépel Rebecca Woodhouse Friederike Ziegler Simon Gilbody |
| author_sort | Helen Lewis |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T09:42:29Z |
| format | Article |
| id | doaj.art-af0eb98ca23e4392b6a9b7c336c393ba |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-10T09:42:29Z |
| publishDate | 2017-02-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-af0eb98ca23e4392b6a9b7c336c393ba2022-12-22T01:53:58ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242017-02-0121810.3310/hta2108008/19/04CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectivenessHelen Lewis0Joy Adamson1Katie Atherton2Della Bailey3Jacqueline Birtwistle4Katharine Bosanquet5Emily Clare6Jaime Delgadillo7David Ekers8Deborah Foster9Rhian Gabe10Samantha Gascoyne11Lesley Haley12Rebecca Hargate13Catherine Hewitt14John Holmes15Ada Keding16Amanda Lilley-Kelly17Jahnese Maya18Dean McMillan19Shaista Meer20Jodi Meredith21Natasha Mitchell22Sarah Nutbrown23Karen Overend24Madeline Pasterfield25David Richards26Karen Spilsbury27David Torgerson28Gemma Traviss-Turner29Dominic Trépel30Rebecca Woodhouse31Friederike Ziegler32Simon Gilbody33Department of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKLeeds and York Partnership NHS Foundation Trust, Leeds, UKDepartment of Health Sciences, University of York, York, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, UKDepartment of Health Sciences, University of York, York, UKNorthumberland, Tyne and Wear NHS Foundation Trust, NIHR Clinical Research Network (Mental Health) North East and North Cumbria, Newcastle upon Tyne, UKPrimary Care Mental Health Service, Leeds Community Healthcare NHS Trust, Leeds, UKMental Health Research Group, University of Durham, Durham, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKTees, Esk and Wear Valleys NHS Foundation Trust, NIHR Clinical Research Network North East and North Cumbria, Research and Development Department, Middlesbrough, UKLeeds and York Partnership NHS Foundation Trust, Leeds, UKDepartment of Health Sciences, University of York, York, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, UKDepartment of Health Sciences, University of York, York, UKLeeds and York Partnership NHS Foundation Trust, Leeds, UKNorthumberland, Tyne and Wear NHS Foundation Trust, NIHR Clinical Research Network (Mental Health) North East and North Cumbria, Newcastle upon Tyne, UKDepartment of Health Sciences, University of York, York, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKLeeds and York Partnership NHS Foundation Trust, Leeds, UKDepartment of Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKDepartment of Health Sciences, University of York, York, UKBackground: 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.https://doi.org/10.3310/hta21080randomised controlled trialcollaborative caresubthreshold depressionolder adultsbehavioural activation |
| spellingShingle | Helen Lewis Joy Adamson Katie Atherton Della Bailey Jacqueline Birtwistle Katharine Bosanquet Emily Clare Jaime Delgadillo David Ekers Deborah Foster Rhian Gabe Samantha Gascoyne Lesley Haley Rebecca Hargate Catherine Hewitt John Holmes Ada Keding Amanda Lilley-Kelly Jahnese Maya Dean McMillan Shaista Meer Jodi Meredith Natasha Mitchell Sarah Nutbrown Karen Overend Madeline Pasterfield David Richards Karen Spilsbury David Torgerson Gemma Traviss-Turner Dominic Trépel Rebecca Woodhouse Friederike Ziegler Simon Gilbody CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness Health Technology Assessment randomised controlled trial collaborative care subthreshold depression older adults behavioural activation |
| 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 |
| title_full | CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness |
| title_fullStr | CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness |
| title_full_unstemmed | CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness |
| title_short | CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness |
| title_sort | collaborative care and active surveillance for screen positive elders with subthreshold depression casper a multicentred randomised controlled trial of clinical effectiveness and cost effectiveness |
| topic | randomised controlled trial collaborative care subthreshold depression older adults behavioural activation |
| url | https://doi.org/10.3310/hta21080 |
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