CASPER-PLUS Trial - collaborative Care in Screen-Positive Elders with major depressive disorder

Chief Investigator:

Prof Simon Gilbody

Principal Investigator:

Prof Carolyn Chew-Graham (National Primary Care Research & Development (Manchester University)), and others from Department of Health Sciences. (University of York), Leeds Institute of Health Sciences (University of Leeds), Care for Mental Health Research (University of Durham) School of Psychology) University of Exeter))

Study Co-ordinator:

Dr Helen Lewis, Dr June Wainwright (Department for Health Sciences (York University))

Funder name / reference number:National Institute for Health Research (UK), Health Technology Assessment Programme (HTA) ref:10/57/43, HTA:10/57/43, Protocol number: R12237
Year2012-2015

Summary:

Study design

Qualitative Study. : CollAborative care in Screen Positive EldeRs with major depressive disorder.

Depression is the most common of all mental health problems. Around 1 in 7 older people (aged over 75) suffer from depression. Depression in older people is associated with poor quality of life and increased health and social care use. As the ageing population grows, solutions are needed to meet the specific needs of older people.

CASPER PLUS is a study of a primary care-based psychological treatment, called 'collaborative care', for older people with depression. The aim of the study is to establish the clinical effectiveness and cost effectiveness of collaborative care for older people with depression.

Primary objective

CASPER-PLUS is a sub study of the wider CASPER study (ISRCTN02202951), a cohort study and randomised controlled trial (RCT) looking at the effectiveness of collaborative care in older patients with sub-threshold depression, using a database screening approach in recruiting patients.

CASPER-PLUS aims to establish the clinical and cost effectiveness of a collaborative care intervention for older people with screen-positive above-threshold depression ('major depressive episode') within a definitive RCT.

More information on CASPER PLUS Research Collaborative TRIALS 

Interventions

Eligible participants who have consented to be in the trial will be randomised into one of two intervention groups: (1) Collaborative Care (including Behavioural Activation) intervention with medication monitoring and management, or (2) usual care. 

This psychological intervention is a bespoke collaborative care designed and delivered specifically for those aged 65 or over with above threshold, case-level depression over 8-10 weekly sessions. Collaborative care will be delivered by a case manager (a primary care mental health worker) within a 'stepped care framework', such that those whose depression deteriorates are 'stepped up' from low intensity care to a more intensive form of management including medication monitoring. 

The five core components of the intervention are described below:

1. Patient - centred assessment and engagement: Patients are first assessed in their own residential setting. The severity of depression and associated behavioural and social deficits are assessed and patient information materials are given.
2. Symptom measurement and monitoring: A standardised assessment of symptom severity is made. Symptom tracking (to judge response, failure to respond or deterioration) is then made at all subsequent patient contacts.
3. Medication management: The prescription of anti-depressant medication is entirely at the discretion of the General Practitioner. We will encourage GPs to consider NICE guidance in their prescribing decisions. The concordant use of medication by patients will be encouraged by the case manager if a prescription has been initiated by the GP. Patient concerns (such as addiction) and non-compliance will be addressed during sessions. There will be active liaison with GPs to encourage follow up patient appointments with the GP if poor concordance is noted.
4. Active follow-up: All patients are followed up by the CM for eight weeks using face to face meetings or telephone contacts. 
5. Delivery of behavioural activation (BA): Patients are offered the option of behavioural activation delivered over eight sessions by their case manager. BA consists of a structured programme of reducing the frequency of negatively reinforced avoidant behaviours in parallel with increasing the frequency of positively reinforcing behaviours to improve functioning and raise mood. During this time patients will remain under the medical care of their GP. 

The additional elements of collaborative care include: telephone support; symptom monitoring and active surveillance (facilitated by computerised case management systems - PC-MIS); medication monitoring; low intensity psychosocial intervention (behavioural activation). The work of case managers is supervised by an older persons' mental health specialist (old age psychiatrist or psychologist).

Control intervention 
Participants allocated to the control condition will receive usual primary care management of case level depression offered by their GP, in line with NICE depression guidance and local service provision