Condition category
Mental and Behavioural Disorders
Date applied
17/02/2014
Date assigned
21/02/2014
Last edited
07/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of a primary care based self-help workbook for older people with low level depression. Our study is part of a larger study called CASPER (http://www.casperstudy.org.uk) which is looking at ways to improve the care that older people receive for different levels of depression. The aim of the study is to see if a self-help workbook designed to help older people with lower level symptoms of depression will improve those symptoms and prevent them turning into more severe depression in the future.

Who can participate?
We are looking for people aged 65 years and over who have symptoms of depression or low mood. You may also be invited because you are in a high-risk group, such as suffering from a health complaint or you are a carer to a relative. We know many people suffer but do not seek help for their low mood.

What does the study involve?
We don't yet know if the new type of care is any better than the care already offered by your GP to treat depression and improve the feelings of people who are finding life difficult. We need to compare the two methods of giving care to see if there is a difference. If you agree to take part, you will be asked to fill in a questionnaire about yourself. Once you have sent back your questionnaire, we will look through your replies to see if you fit with our needs for the study. If you do, one of our team will call you to ask you some more questions. We will then randomly allocate you to one of two groups: either a usual GP care group or the self-help workbook group. Both groups will also be sent a questionnaire after 4 months and 12 months. If you are put into the usual care group, your GP care will continue as normal. We will still ask you to fill in and send back the questionnaires mentioned above. If you are put into the self-help workbook group, you will be sent a self-help workbook through the post to read and work through in your own time at a pace that suits you. You will receive up to three telephone calls from a researcher to offer help with the workbook if needed and answer any questions you may have. At the end of the study we will compare the two groups to see if the self-help workbook group show fewer symptoms of depression than the usual GP care group over time.

What are the possible benefits and risks of taking part in this study?
We cannot promise that taking part in this study will help you. Taking part could improve the treatment offered to people suffering from depression in the future. By taking part in this study you may receive help that isn't normally offered to people. The possible disadvantages are that it takes up some of your time. It takes time to complete questionnaires. For those in the self-help workbook group, time will be spent reading the booklet and working through the activities.

Where is the study run from?
The study is being organised by the University of York who is working with teams at different areas around York, Harrogate, Hull, Leeds, Durham and Newcastle and Northumberland, UK.

When is the study starting and how long is it expected to run for?
Recruitment is expected to start in early February 2014 and will continue until the end of July 2014; the follow-up questionnaires will continue until July 2015.

Who is funding the study?
National Institute of Health Research, UK.

Who is the main contacts?
Professor Simon Gilbody (Chief Investigator), sg519@york.ac.uk
Doctor Helen Lewis (Trial Manager), helen.lewis@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Simon Gilbody

ORCID ID

Contact details

Department of Health Sciences
University of York
Area 4
2nd Floor
Alcuin Research Resources Centre
Heslington Campus
Heslington
York
YO10 5DD
United Kingdom
-
simon.gilbody@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/19/04

Study information

Scientific title

A multi-centred randomised controlled trial to determine whether a specifically designed guided self-help workbook, using behavioural activation principles in addition to GP usual care is more effective than GP usual care alone for older people with sub-threshold depression symptoms

Acronym

SHARD

Study hypothesis

A low intensity self-help workbook based on behavioural activation principles alongside usual GP care will reduce depression amongst older people displaying sub-threshold symptoms of depression more effectively than usual care alone.

Ethics approval

NRES Committee Yorkshire & The Humber - Leeds, 23/12/2013, REC ref: 10/H1306/61

Study design

Pragmatic two-arm randomised controlled multi-site trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

Sub-threshold depression in people 65 years and older

Intervention

Eligible and consenting participants will be randomly allocated to one of two comparative arms.
This sub-study forms part of a larger funded project supported by the Department of Health's National Institute of Health Research Health Technology Assessment programme (NIHR HTA). Participants will be identified through the CASPER recruitment process and followed up alongside the main study (CASPER: ISRCTN02202951).

Intervention arm:
BA self-help workbook plus usual primary care
Participants will be sent a specially-designed self-help workbook produced for the purposes of the SHARD trial. This booklet is entitled ‘Helping you to maintain a positive mood in older age: a self-help workbook’ and is 20 pages long. The workbook is based on clear principles of an evidence-supported psychological treatment (behavioural activation – BA) for depression. The core purpose of the workbook is to introduce simple behavioural strategies for improving mood and the rationale is to enable patients to regain functionality lost or reduced as part of low mood. By using principles of BA, participants are encouraged to (1) re-establish their daily routine, (2) increase pleasurable external activities and (3) address necessary issues such as unpaid bills.

The self-help workbook has been tested for readability and designed after extensive consultation with older people with depression and their carers. After consenting to take part, participants to this arm of the trial will be sent a copy of the self-help workbook with an explanatory cover letter. Participants will also receive up to three telephone calls designed to check that the materials have arrived and to offer practical advice and encouragement to use the materials. In addition all participants will receive the usual care of their GP.

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient-reported depression severity (Patient Health Questionnaire 9 - PHQ-9) at 4 months and again at 12 months to examine any sustained impact of the intervention.

Secondary outcome measures

1. Health-related quality of life (physical and mental component of the SF-12) at 4 months and 12 months
2. Health-state utility (EQ-5D) at 4 months and 12 months

Overall trial start date

01/02/2014

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be identified in primary care. Our target population will be older people (aged 65 and above) who screen-positive for depression on a two question brief depression screen (sometimes referred to as the 'Whooley' questions after their initial validation study), but who on further assessment do not fulfil criteria for DSM-IV Major Depressive Disorder (MDD), and therefore have sub-threshold depression.

Inclusion criteria:
Aged 65+ years and with a read code for any one of the following:
1. Depression
2. Anti-depressant medication
3. Ischemic heart disease (IHD)
4. Diabetes
5. Chronic obstructive pulmonary disease (COPD)
6. Arthritis
7. Carer

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

412

Participant exclusion criteria

1. Not currently experiencing psychotic symptoms
2. No known alcohol dependency (as recorded on GP records)
3. No known significant cognitive impairment; unable to give informed consent (as recorded on GP records)
4. No known recent bereavement (as recorded on GP records)
5. No known terminal malignancy (as recorded on GP records)

Recruitment start date

01/02/2014

Recruitment end date

31/07/2014

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

c/o Sue Final
University Intellectual Property Manager
Enterprise and Innovation Office
Innovation Centre
York Science Park
Heslington
York
YO10 5DG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment programme (HTA) (UK) grant ref.: 08/19/04

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes