Data category | Information |
---|---|
Primary registry and trial identifying number | ISRCTN 45842879 |
Date of registration in primary registry | 24 July 2012 |
Secondary identifying numbers | HTA - Project: 10/57/43 CASPER Plus |
Source of monetary of material support | National Institute of Health Research Health Technology Assessment (NIHR HTA) |
Primary sponsor | University of York |
Contact for scientific and/or public queries | Professor Simon Gilbody 01904 430000 (simon.gilbody@york.ac.uk) |
Public title | The CASPER Plus study |
Scientific title | Collaborative Care for Screen-Positive Elders with major depressive disorder |
Countries of recruitment | UK |
Health condition(s) or problem(s) studied | Depression in older people |
Intervention(s) | Behavioural activation (BA) and medication management delivered in a collaborative care framework by a case manager liaising with general practitioners/health professionals/third sector, with supervision from a mental health specialist |
Key inclusion and exclusion criteria | Inclusion criteria: Aged 65Â years and over; screen positive to at least one of the Whooley questions and who, on further assessment with the MINI diagnostic tool and PHQ-9 questionnaire, have DSM-IV Major Depressive Disorder (MDD). See protocol paper |
Exclusion criteria: Known alcohol dependency (as recorded on GP records); any known co-morbidity that would in the GP’s opinion make entry to the trial inadvisable (for example, recent evidence of self-harm, known current thoughts of self-harm, significant cognitive impairment); other factors that would make an invitation to participate in the trial inappropriate (for example, recent bereavement, terminal illness); known to be experiencing psychotic symptoms (as recorded on GP records) | |
Study type | Randomised controlled trial |
Interventional | |
Allocation: randomised | |
Masking: none | |
Primary purpose: prevention and/or improvement of symptoms | |
Date of first recruitment | 15 September 2012 |
Target sample size | 450 |
Recruitment status | Recruiting |
Primary outcome(s) | Depression severity at 4Â months (following intervention) by self-report using the Patient Health Questionnaire 9 (PHQ-9) on a continuous scale. We will also measure outcome at 12 and 18Â months using the PHQ-9 to examine any sustained impact of the intervention |
Secondary outcome(s) | Secondary outcomes include the SF-12 and GAD-7 at 4, 12 and 18Â months. We will also collect data on somatic symptom severity using the PHQ-15, participant resilience using the CD-RISC2 and cost effectiveness including the EQ-5D, prescribed medication and health and social care use. See protocol paper for references |