A study to help identify depression in patients aged 65 years and older who are registered with a GP in the North of England
| ISRCTN | ISRCTN11841241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11841241 |
| IRAS number | 305842 |
| Secondary identifying numbers | CPMS 53084, IRAS 305842 |
- Submission date
- 14/10/2022
- Registration date
- 27/10/2022
- Last edited
- 04/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
One in four people aged 65 years plus are depressed. Many people do not receive support or help for symptoms of depression. One reason for this is that it can be difficult for healthcare professionals to identify when a patient is depressed. The Geriatric Depression Scale (GDS) is a short questionnaire or 'screening tool' that can be used to identify when someone who is older than 65 years has symptoms of depression. A healthcare professional can use this and then talk to the patient about how they are feeling and decide on a course of action.
Currently there is little evidence about whether screening people who are over 65 years with the GDS is a good way of identifying whether someone has symptoms of depression. The researchers have previously shown that when they used the GDS with older participants and told their GPs when they identified symptoms of depression, when they checked again after 6 months the severity of their depression had reduced. This study aims to find out whether screening participants with the GDS followed by alerting the GP of participants who could have symptoms of depression, improves the GDS score 6 months later.
Who can participate?
People who are over the age of 65 years, do not have a diagnosis of depression or are waiting to receive treatment for depression, are living at home (not in a residential care home), are registered with a GP practice in the North of England, and who are happy for the study team to contact their GP about their mental and physical health.
What does the study involve?
Potentially eligible patients who live in the North of England and are registered with a participating GP practice will receive an invitation in the post to take part in the study. They will be asked to complete a consent form and questionnaire and send it back to the York Trials Unit, University of York. Researchers will check that the patient is eligible for the study. If eligible, researchers will calculate the participants' GDS score and will write to both the participant and their GP to tell them their score. The participant's GP will review the GDS score and contact the participant where necessary. After 6 months the participants will be sent another questionnaire to complete and send back to York Trials Unit. Some participants will be asked to take part in an interview about their experiences of being in the study.
What are the possible benefits and risks of participating?
If the GDS identifies that a participant has symptoms of depression and proposes a course of action, these symptoms may be reduced. There may not be many other direct benefits of participating in this study. However, if enough people take part in the study, the results will provide valuable information about screening for depression in patients who are 65 years or more.
The researchers do not think that taking part in the study poses any additional risks for participants. For participants, taking part in the study will involve some time to complete questionnaires and possibly discussions with their GP.
Where is the study run from?
University of York (UK)
When is the study starting and how long is it expected to run for?
September 2021 to January 2024
Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
1. Caroline Fairhurst, caroline.fairhurst@york.ac.uk
2. Sarah Cockayne, sarah.cockayne@york.ac.uk
3. Laura Clark, laura.clark@york.ac.uk
4. Ailish Bryne, ailish.byrne@york.ac.uk
Contact information
Scientific
York Trials Unit
Department of Health Sciences
Faculty of Sciences
Ground Floor ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0003-0547-462X |
|---|---|
| Phone | +44 (0)1904 321513 |
| caroline.fairhurst@york.ac.uk |
Study information
| Study design | Non-randomized; Interventional; Design type: Treatment, Screening, Diagnosis, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Case finding for depression in primary care: a regression discontinuity design CASCADE study |
| Study acronym | CASCADE |
| Study objectives | Screening for depression in patients aged 65 years and older, who are living in the community and registered with a GP in the North of England, using the Geriatric Depression Scale (GDS) and informing the patient and their GP if the GDS score indicates symptoms of low mood or depression will reduce symptom severity six months later. |
| Ethics approval(s) | Approved 12/08/2022, Yorkshire and The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 972 2504, +44 (0)207 104 8134; leedswest.rec@hra.nhs.uk), ref: 22/YH/0119 |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Participants will complete the GDS at baseline and post the questionnaire back to the York Trials Unit (YTU), University of York. Members of the research team at YTU will score the GDS and if the score is suggestive of mild to moderate depression (score of 5 or more), then YTU will write to the participant and their GP to inform them. The GP will read the letter and decide on an appropriate course of action/treatment for the participant. For participants whose score does not indicate mild or moderate depression, a letter will be sent to their GP to inform them that their patient is taking part in the study and that the GDS score did not indicate that the patient was experiencing depressive symptoms. At 6 months, YTU will only notify GPs about new scores of 5 and over (i.e if the participant previous reported a GDS of 0-4 inclusive at baseline). |
| Intervention type | Other |
| Primary outcome measure | Symptoms of low mood and depression measured using the Geriatric Depression Scale (GDS) at baseline and 6 months |
| Secondary outcome measures | 1. Health-related quality of life measured by the EQ-5D-5L at baseline and 6 months 2. Health service resource use with a specific focus on mental health services, including NHS and private care, use of medications, and self-care at 6 months 3. Acceptability of the intervention to patients and care providers, and if and how screening could be incorporated in practice, assessed using interviews during the recruitment and follow-up stages of the study |
| Overall study start date | 01/09/2021 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2089; UK Sample Size: 2089 |
| Total final enrolment | 1020 |
| Key inclusion criteria | 1. Aged 65 years and over 2. Community-dwelling 3. Based in the North of England 4. Willing and able to provide consent |
| Key exclusion criteria | 1. Currently have a diagnosis of depression 2. Currently receiving or waiting for treatment for depression 3. Do not consent to their GP being contracted by the research team about physical or mental health concerns |
| Date of first enrolment | 22/09/2022 |
| Date of final enrolment | 31/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Faculty of Sciences
Ground Floor ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom
Bridlington
YO15 2AT
United Kingdom
DH7 0BD
United Kingdom
Ashton-under-Lyne
OL6 6HD
United Kingdom
Swinton
Manchester
M27 0EW
United Kingdom
Balby
Doncaster
DN4 OTH
United Kingdom
Rotherham
S65 1DA
United Kingdom
Heeley
Sheffield
S2 3AJ
United Kingdom
Northallerton
DL7 8AW
United Kingdom
Selby
YO8 4QH
United Kingdom
49 Goodhart Road
Hull
HU7 4DW
United Kingdom
Huddersfield
HD8 0SJ
United Kingdom
Bearpark
Durham
DH7 7DG
United Kingdom
S35 9XQ
United Kingdom
Cottingham
HU16 5QJ
United Kingdom
York
YO43 3FF
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
Flatts Lane
Middlesbrough
TS6 0SZ
England
United Kingdom
| Phone | +44 (0)7469 376206 |
|---|---|
| tewv.researchanddevelopment@nhs.net | |
| Website | https://www.tewv.nhs.uk/ |
"ROR" |
https://ror.org/04s03zf45 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 28/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. The researchers intend to publish the protocol in a high-impact peer-reviewed journal; this submission is planned by 01/04/2023 2. The researchers intend to publish the main results paper in a high-impact peer-reviewed journal, this submission is planned for 31/08/2024 Updated 05/06/2023: The researchers intend to publish the protocol in a high-impact peer-reviewed journal; this submission is planned by 31/07/2023 |
| IPD sharing plan | The datasets analysed during the current study will be available upon request from the Chief Investigator, Caroline Fairhurst (caroline.fairhurst@york.ac.uk), in an anonymised format following the publication of the main study results. Reasonable requests by researchers for data to conduct secondary analyses will be considered by the Study Management Group. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 04/02/2025 | Yes | No |
Additional files
Editorial Notes
04/02/2025: Plain English results added.
14/08/2024: The intention to publish date was changed from 31/08/2024 to 28/02/2025.
18/12/2023: The following changes have been made:
1. The overall study end date was changed from 31/12/2023 to 31/01/2024.
2. The total final enrolment number was changed from 1019 to 1020.
14/09/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2023 to 31/12/2023.
2. The plain English summary was updated to reflect these changes.
3. The total final enrolment was added.
05/06/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/05/2023 to 31/07/2023.
2. Kirkburton Health Centre, Dunelm Medical Practice, Ecclesfield Group Practice, King Street Medical Centre,
and Market Weighton Group Practice were added to the study participating centres.
3. The publication and dissemination plan was updated.
04/04/2023: St Johns Group Practice, Clifton Medical Centre, Heeley Green Surgery, Mayford House Surgery, Posterngate Surgery and James Alexander Family Practice were added as trial participating centres.
15/03/2023: The recruitment end date was changed from 31/03/2023 to 31/05/2023.
31/01/2023: The recruitment end date was changed from 01/01/2023 to 31/03/2023.
14/10/2022: Trial's existence confirmed by the NIHR.
