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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