Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1522 participants
OBSERVATIONAL
2022-09-15
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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CASPER
A multi-centred, pragmatic, two-arm parallel open RCT. Participants with Subthreshold depression were individually randomised (1:1) to receive either collaborative care focusing on behavioural activation or usual GP care
Collaborative care
Participants in the intervention group were allocated a receive a low-intensity programme of behavioural activation specifically designed for adults ≥65 with subthreshold depression. An allocated case manager (primary care mental health worker/ Improving Access to Psychological Therapy) delivered collaborative care for an intended 8-10 weeks. This ran alongside general practitioner (GP) usual care. Collaborative care in both CASPER and CASPER+ trial included weakly telephone/ face-to-face support, active surveillance and symptom monitoring
Usual General Practitioner (GP) care
Participants allocated to the control group received usual GP care. Participants did not receive any additional care to their usual primary care management for subthreshold (CASPER) or Major (CASPER+) depression in line with National Institute for Health and Care Excellence (NICE) guidelines as implemented in their GP and local service provision.
CASPER+
A multi-centred, pragmatic, two-arm parallel open RCT. Participants with Major depression were individually randomised (1:1) to receive either collaborative care focusing on behavioural activation or usual GP care
Collaborative care
Participants in the intervention group were allocated a receive a low-intensity programme of behavioural activation specifically designed for adults ≥65 with subthreshold depression. An allocated case manager (primary care mental health worker/ Improving Access to Psychological Therapy) delivered collaborative care for an intended 8-10 weeks. This ran alongside general practitioner (GP) usual care. Collaborative care in both CASPER and CASPER+ trial included weakly telephone/ face-to-face support, active surveillance and symptom monitoring
Usual General Practitioner (GP) care
Participants allocated to the control group received usual GP care. Participants did not receive any additional care to their usual primary care management for subthreshold (CASPER) or Major (CASPER+) depression in line with National Institute for Health and Care Excellence (NICE) guidelines as implemented in their GP and local service provision.
SHARD
A multi-centred, pragmatic, two-arm parallel open RCT. Participants with Subthreshold depression were individually randomised (1:1) to receive the self-help booklet based on the principles of behavioural activation or usual GP care
Usual General Practitioner (GP) care
Participants allocated to the control group received usual GP care. Participants did not receive any additional care to their usual primary care management for subthreshold (CASPER) or Major (CASPER+) depression in line with National Institute for Health and Care Excellence (NICE) guidelines as implemented in their GP and local service provision.
Behavioral Activation Self-Help guide
Participants in the intervention arm were provided with a self-help booklet based on clear principles of BA for depression. The purpose of the booklet was to introduce simple behavioural strategies for improving mood. Participants were encouraged to (1) re-establish their daily routine, (2) increase meaningful activities and (3) reduce avoidance behaviours. Participants also received 3 phone calls at week 1, 3 and 6 designed to check the booklet had arrived and to encourage the use of the materials. All participants received their usual GP care
Interventions
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Collaborative care
Participants in the intervention group were allocated a receive a low-intensity programme of behavioural activation specifically designed for adults ≥65 with subthreshold depression. An allocated case manager (primary care mental health worker/ Improving Access to Psychological Therapy) delivered collaborative care for an intended 8-10 weeks. This ran alongside general practitioner (GP) usual care. Collaborative care in both CASPER and CASPER+ trial included weakly telephone/ face-to-face support, active surveillance and symptom monitoring
Usual General Practitioner (GP) care
Participants allocated to the control group received usual GP care. Participants did not receive any additional care to their usual primary care management for subthreshold (CASPER) or Major (CASPER+) depression in line with National Institute for Health and Care Excellence (NICE) guidelines as implemented in their GP and local service provision.
Behavioral Activation Self-Help guide
Participants in the intervention arm were provided with a self-help booklet based on clear principles of BA for depression. The purpose of the booklet was to introduce simple behavioural strategies for improving mood. Participants were encouraged to (1) re-establish their daily routine, (2) increase meaningful activities and (3) reduce avoidance behaviours. Participants also received 3 phone calls at week 1, 3 and 6 designed to check the booklet had arrived and to encourage the use of the materials. All participants received their usual GP care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
65 Years
ALL
No
Sponsors
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University of York
OTHER
Teesside University
OTHER
Responsible Party
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Alexandra Carne
Chief Investigator
Principal Investigators
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Alexandra S Carne, PhD Student
Role: PRINCIPAL_INVESTIGATOR
Teesside University/ Univeristy of York
Locations
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Teesside University
Middlesbrough, , United Kingdom
Countries
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References
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Bosanquet K, Adamson J, Atherton K, Bailey D, Baxter C, Beresford-Dent J, Birtwistle J, Chew-Graham C, Clare E, Delgadillo J, Ekers D, Foster D, Gabe R, Gascoyne S, Haley L, Hamilton J, Hargate R, Hewitt C, Holmes J, Keding A, Lewis H, McMillan D, Meer S, Mitchell N, Nutbrown S, Overend K, Parrott S, Pervin J, Richards DA, Spilsbury K, Torgerson D, Traviss-Turner G, Trepel D, Woodhouse R, Gilbody S. CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness. Health Technol Assess. 2017 Nov;21(67):1-252. doi: 10.3310/hta21670.
Gilbody S, Brabyn S, Mitchell A, Ekers D, McMillan D, Bailey D, Hems D, Chew Graham CA, Keding A, Bosanquet K; SHARD collaborative. Can We Prevent Depression in At-Risk Older Adults Using Self-Help? The UK SHARD Trial of Behavioral Activation. Am J Geriatr Psychiatry. 2022 Feb;30(2):197-207. doi: 10.1016/j.jagp.2021.06.006. Epub 2021 Jun 19.
Lewis H, Adamson J, Atherton K, Bailey D, Birtwistle J, Bosanquet K, Clare E, Delgadillo J, Ekers D, Foster D, Gabe R, Gascoyne S, Haley L, Hargate R, Hewitt C, Holmes J, Keding A, Lilley-Kelly A, Maya J, McMillan D, Meer S, Meredith J, Mitchell N, Nutbrown S, Overend K, Pasterfield M, Richards D, Spilsbury K, Torgerson D, Traviss-Turner G, Trepel D, Woodhouse R, Ziegler F, Gilbody S. 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 Technol Assess. 2017 Feb;21(8):1-196. doi: 10.3310/hta21080.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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ISRCTN02202951
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN45842879
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN95270332
Identifier Type: REGISTRY
Identifier Source: secondary_id
8838
Identifier Type: -
Identifier Source: org_study_id
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