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Table 1 The SPIRIT checklist

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

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 65 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 4 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 18 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 18 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