Title: The CASPER-PLUS Trial: Collaborative care for screen-positive elders with Major Depressive Disorder
Funder: Department of Health and Social Care

Abstract: CASPER-PLUS is a trial of a complex intervention for severe depression, for which we have completed initial MRC framework steps (review, modelling, manualisation, demonstration of feasibility in a pilot trial). DESIGN: Randomised controlled trial with concurrent economic & qualitative evaluation (we use a cohort multiple RCT – cmRCT, and incorporate a fully randomised patient preference design). SETTING: UK Primary care (established trials network of research-active practices in Yorkshire) TARGET POPULATION: older people (aged 65 and older) in primary care with screen-positive depression and who meet the threshold for DSM-IV Major Depressive Disorder (MDD). TECHNOLOGY BEING ASSESSED: active intervention Collaborative Care delivered by a trained case manager of 8-10 weekly sessions. The defining features of collaborative care include a supervised case manager, working with the patient, with access to the GP and a mental health specialist (psychiatrist/psychologist). A core feature will be ‘medication management’, whereby guideline-complaint antidepressant prescriptions will be delivered by the GP and monitored by the case manager. The additional elements of collaborative care include: telephone support; symptom monitoring and active surveillance; manualised brief psycho-social intervention (behavioural activation). The comparator technology will be general primary care management of case-level depression, in line with NICE depression guidance and with due reference to local service provision (‘usual NHS care’). The CASPER treatment manual is already written and has been shown to be acceptable in older people. PRIMARY OUTCOME: DSM-IV Major Depressive Disorder (MDD) at 4 months according to a gold standard interviewer-based diagnosis SECONDARY OUTCOMES: self reported depression severity (PHQ9); HRQoL (SF-12); utility (EQ5D); anxiety (GAD7); somatoform symptoms (PHQ15) and disability (Sheehan Disability scale); each at 4, 12 and 18 months. ECONOMIC EVALUATION: the incremental cost per (EQ5D) QALY will be calculated from both the NHS and societal perspective. PROCESS EVALUATION: we will examine the acceptability (to patients and healthcare staff) and barriers and facilitators to the use screening and the uptake of collaborative care using qualitative methods. SAMPLE SIZE: N=400 (accounting for therapist clustering ICC 0.02; effect size 0.35; alpha 0.05; beta 0.80). PROJECT TIMETABLE: CASPER-PLUS will last for 45 months (including 18 mo follow-up). Research governance and ethics (mo -3 to 0); internal pilot trial of recruitment (mo. 0-12); full trial recruitment (mo- 12-24) final follow-up (mo. 24 - 42 and study analysis (mo. 42-45).

Lay abstract: Depression is very common amongst older people. Older people often experience long standing physical health problems and the presence of poor physical heath makes older people more susceptible to depression. When older people become depressed, they experience very poor quality of life, and are at increased risk of hospitalisation, and even death. This study is about older people with severe depression, who might benefit from both anti-depressants and psychological therapy. Currently there is little that is done for the majority of these people in the NHS, other than the routine prescription of anti-depressants by GPs. Older people with depression often have a poor understanding of the role of medication and compliance is poor. Research into severe forms of depression shows that treatments can be delivered over brief periods of time with the patient at the centre of care. The need for a trial of collaborative care was recently highlighted in a set of guidelines on depression issued by NICE. The CASPER programme of research will address this gap in the evidence outlined above. We will judge whether collaborative care improves peoples’ mental health using an internationally recognised diagnosis of depression to establish what proportion of patients move from having depression (before treatment) to not being depressed (after treatment). We will also measure depression using a scale used by general practitioners (the PHQ9). We will conduct a fair test of collaborative care by comparing it with a group of people who receive usual care from their GP. People with depression will be given either collaborative care or their usual care according to the play of chance, and nobody will be denied care by taking part in this trial. Few alterations will be made to usual care in order to make a valid comparison that is applicable to patients across the NHS. We have checked with older people and their carers, and they agree that this is a fair test and that this is important research. We have an existing trial of collaborative care for people with less severe forms of depression (subthreshold depression). In the process of conducting this already-funded trial we will identify a large number of people with more severe forms of depression (Major Depressive Disorder). At present we offer no additional care for this important group, despite the above clinical need and treatment uncertainties. CASPER-plus will test treatment for these patients, and the significant costs of conducting a trial (recruiting GPs; screening records; visiting patients) will already be met. This means our new trial will cost much less than would be the case if we starting the CASPER-plus trial from scratch. Because we are already conducting a trial, we can deliver the answer to this question much more quickly. This is an example of a research method that makes trials more efficient and feasible and we will learn about how this method can be used more readily in the NHS.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH