Condition category
Mental and Behavioural Disorders
Date applied
01/06/2009
Date assigned
03/06/2009
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression is one of the most common mental disorders worldwide. The symptoms of depression can vary greatly from person to person, but generally include low mood, problems with sleeping and/or eating, and a general loss of interest in life. Around 1 in 7 older people suffer from depression. Depression in this age group is associated with poor quality of life along with increased health and social care use. The CASPER trial is a study of a primary care based psychological treatment called collaborative care for older adults with sub-threshold depression. Sub-threshold depression is when patients suffer from a few depressive symptoms but insufficient to meet formal diagnostic criteria for major depression. The aim of the study is to test whether or not collaborative care is effective at preventing symptoms of depression from getting worse, and to see if it would be value for money for the National Health Service (NHS).

Who can participate?
Adults showing signs of low mood, who are aged 75 and over for the first phase of the study and 65 and over for the main part of the study.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive six to eight weekly sessions of low intensity collaborative care, delivered by a specialist health worker (case manager). Collaborative care may also involve medication management, in cases where the participant has been prescribed medication. Participants in this group also receive telephone support, symptom monitoring (so that action can be taken if symptoms of depression appear or get worse) and behavioural activation (a type of therapy which focuses on changing behaviour to improve symptoms). Those in the second group receive standard care, delivered by their GP. At the start of the study and then again after 4 and 12 months, participants in both groups complete a number of questionnaires in order to assess their general and mental well-being.

What are the possible benefits and risks of participating?
Being offered collaborative care is a possible benefit for participants as it may not be currently available in their GP practice. There are no notable risks involved with taking part in the study.

Where is the study run from?
University of York (UK)

When is the study starting and how long is it expected to run for?
October 2009 to November 2014

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Simon Gilbody
sg519@york.ac.uk

Trial website

http://www.york.ac.uk/healthsciences/research/mental-health/projects/casper/

Contact information

Type

Scientific

Primary contact

Prof Simon Gilbody

ORCID ID

Contact details

Area 4
Seebohm Rowntree Building
Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 321370
sg519@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/19/04

Study information

Scientific title

Collaborative care and active surveillance for screen-positive elders with sub-clinical depression: a pilot study and definitive and randomised evaluation

Acronym

CASPER

Study hypothesis

1. To develop a low intensity collaborative care intervention based upon evidence-supported models of care for older adults with screen-positive sub-threshold depression
2. To establish the acceptability and uptake of this service by older adults with screen-positive sub-threshold depression in primary and residential care settings
3. To test the feasibility of conducting a successful trial of low intensity collaborative care intervention for older adults with screen-positive sub-threshold depression
4. To establish the clinical effectiveness of low intensity collaborative care intervention for older adults with screen-positive sub-threshold depression
5. To examine the cost effectiveness of a low intensity collaborative care intervention for older adults with screen-positive sub-threshold depression across a range of health and social care costs

Ethics approval

NHS Leeds East Research Ethics Committee, 28/09/2010, 10/H1306/61

Study design

Randomised controlled trial, including a prospective economic and qualitative evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

http://www.york.ac.uk/healthsciences/research/mental-health/projects/casper/participants/

Condition

Sub-clinical depression

Intervention

Active intervention:
Low intensity form of collaborative care delivered by a case manager of 6 - 8 weekly sessions. Collaborative care is the most effective and efficient way of organising and delivering depression care in primary care settings. The defining features of collaborative care include a case manager, working with the patient, with access to the GP and a mental health specialist (old age psychiatrist or psychologist). 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 (moving from sub-threshold to threshold) are 'stepped up' from low intensity care to a more intensive form of management (including anti-depressant medication). The additional elements of collaborative care include:
1. Telephone support
2. Symptom monitoring and active surveillance
3. Brief psycho-social intervention (behavioural activation)

Control intervention:
The comparator technology will be general primary care management of sub-threshold depression, in line with National Institute for Health and Clinical Excellence (NICE) depression guidance and with due reference to local service provision.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Self reported depression severity (as measured by the 9-item Patient Health Questionnaire [PHQ-9]) at 4 months as a continuous measure.

Secondary outcome measures

Updated secondary outcome measures:
Note: The secondary outcome measures were updated to the following prior to recruitment of the first participant into the study.
1. Depression severity and symptomatology is measured using the 9-item Patient Health Questionnaire (PHQ-9) at baseline and 12 months
2. Binary depression severity at 4 and 12 months is measured using the 9-item Patient Health Questionnaire (PHQ-9) using scores ≥ 10 to designate moderate depression caseness at 4 and 12 months
3. Health state utility is measured using European Quality of Life-5 Dimensions (EQ-5D) at 4 and 12 months
4. Physical health and somatic complaints is measured using a 15-item scale using Patient Health Questionnaire-15 items (PHQ-15) at baseline, 4 and 12 months
5. Quality of life is measured using Short Form questionnaire-12 items (SF-12) and EQ-5D at baseline, 4 and 12 months
6. Psychological anxiety is measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale at baseline, 4 and 12 months
7. Resilience and the ability to bounce back is measured using the Connor–Davidson Resilience Scale two-item version (CD-RISC 2) at baseline, 4 and 12 months
8. Self-report medication data at baseline, 4 and 12 months (Not applicable to participants who fully withdraw from the study)
9. Healthcare resource use data obtained from GP practices measures:
9.1. Participants’ contacts with GPs (appointments, home visits or telephone consultations)
9.2. Participants’ contacts with practice nurses (appointments or telephone consultations)
9.3. Prescriptions across each participant's follow up period of 12 months (or up until they leave the practice/die)
10. Mortality across the follow up period is measured using a data linkage service established with the Health and Social Care Information Centre to provide regular updates from the Office for National Statistics mortality data on any trial participants who had died while in the study

Original secondary outcome measures:
1. ICD depression status at 4 and 12 months
2. Health related quality of life is measured using the 36-item Short Form Health Survey (SF-36) at 4 and 12 months
3. Health-state utility is measured using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at 4 and 12 months

Overall trial start date

01/10/2009

Overall trial end date

14/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 10/03/2016:
1. Age ≥ 75 years during the pilot phase or ≥ 65 years during the main trial
2. Identified by a GP practice as being able to take part in collaborative care

Original inclusion criteria:
Elderly people (aged 75 years and older, either sex) with screen-positive depression on the Quality Outcomes Framework Depression 1 (QOF DEP1) - compliant 'two depression screening questions', but do not reach the threshold for International Classification of Disease, version 10 (ICD 10) moderate depressive disorder

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

486 patients (243 in each group). Allowing for a potential loss to follow-up of 10% the final sample size needed is 540 patients (270 in each group). The target sample size was revised upwards in view of higher than anticipated loss to follow- up and to enable us to retain the original statistical power estimate. The total sample size required was 658 patients (329 in each arm).

Participant exclusion criteria

Exclusion criteria as of 10/03/2016:
Those identified by a primary care clinician as:
1. Having a known alcohol dependency (as recorded on GP records)
2. Experiencing psychotic symptoms (as recorded on GP records)
3. Having any known comorbidity that would, in the GP’s opinion, make entry to the trial inadvisable (e.g. recent evidence of suicidal risk/self-harm, significant cognitive impairment)
4. Being affected by other factors that would make an invitation to participate in the trial inappropriate (e.g. recent bereavement, terminal malignancy)

Original exclusion criteria:
1. Reached threshold for ICD 10 moderate depressive disorder
2. Patients with alcohol dependence
3. Patients with dementia

Recruitment start date

24/05/2011

Recruitment end date

09/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 430000
nm513@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21988800
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26766034

Publication citations

  1. Protocol

    Mitchell N, Hewitt C, Adamson J, Parrott S, Torgerson D, Ekers D, Holmes J, Lester H, McMillan D, Richards D, Spilsbury K, Godfrey C, Gilbody S, A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial., Trials, 2011, 12, 225, doi: 10.1186/1745-6215-12-225.

Additional files

Editorial Notes

30/09/2016: Publication reference added. 15/03/2016: Plain English summary added. 11/03/2016: The overall trial end date has been updated from 30/06/2013 to 14/11/2014, and the recruitment dates have been updated from 01/10/2009 - 30/06/2013 to 24/05/2011 - 09/07/2013. The target number of participants has been increased from 500 to 658, and the ethics approval information has been added. In addition, secondary outcome measures and the inclusion and exclusion criteria have been updated.