ISRCTN ISRCTN16572400
DOI https://doi.org/10.1186/ISRCTN16572400
IRAS number 327529
Secondary identifying numbers CPMS 58957, IRAS 327529
Submission date
17/11/2023
Registration date
28/11/2023
Last edited
28/10/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Self-harm, defined as intentional self-injury or poisoning regardless of intention, in young people is an international health concern. The number of young people presenting to general practitioners (GPs) after self-harm is increasing. Evidence shows that currently there are no effective treatments for GPs to use with young people who have harmed themselves and this impacts on GPs' confidence of managing these patients. To address this, researchers have developed the COPING (CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm) treatment in partnership with young people aged 16-25 with experience of self-harm and GPs. The COPING treatment is a new coproduced treatment for GPs to use with young people aged 16-25 years to help them avoid future self-harm. The COPING treatment is to be delivered by GPs across two 10-minute GP appointments and is a talking treatment targeting psychosocial factors in the young person. The aim of this study is to deliver COPING to all participants across GP practices, to find out whether a clinical trial of COPING is doable in the NHS and to help inform a future larger study.

Who can participate?
Young people aged 16-25 years with a history of self-harm in the last 12 months

What does the study involve?
The researchers will recruit up to 12 GP practices across England and train practice GPs to deliver the COPING intervention. Participants will receive the COPING intervention and be asked to complete three follow-up questionnaires. They and GPs will be invited for an interview to hear their thoughts on COPING.

What are the possible benefits and risks of participating?
It is hoped that participants will find the COPING intervention useful and acceptable. There is the potential that COPING leads to reduced participant distress, repeat self-harm, and suicide and death risk. There is risk that participants may describe self-harm or suicidal intent when returning self-report questionnaires or while partaking in an interview. Two risk protocols have been developed: should likely risk to participants be identified, the relevant risk protocol will be activated, and the participant's GP notified. All participants will receive a Staying Safe Sheet which lists free support services for use when needed.

Where is the study run from?
Keele University (UK)

When is the study starting and how long is it expected to run for?
December 2019 to December 2025

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

Who is the main contact?
Dr Faraz Mughal, f.mughal@keele.ac.uk

Study website

Contact information

Dr Faraz Mughal
Scientific

School of Medicine
Keele University
Newcastle-under-Lyme
ST5 5BG
United Kingdom

ORCiD logoORCID ID 0000-0002-5437-5962
Phone +44 (0)1782 733991
Email f.mughal@keele.ac.uk

Study information

Study designNon-randomized study design
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet https://www.keele.ac.uk/research/ourresearch/medicine/primarycareresearchthemes/mentalhealth/coping/
Scientific titleThe CO-produced Psychosocial INtervention delivered by GPs for young people who self-harm (COPING) feasibility study
Study objectivesThe main objective of this study is to examine aspects of the feasibility of a main randomised clinical trial of the COPING intervention within the areas of recruitment, delivery, and retention and follow-up.
Ethics approval(s)Approved 13/11/2023, East of England, Cambridge East Research Ethics Committee (2 Redman Place, London, EC20 1JQ, UK; +44 (0)2071048181; cambridgeeast.rec@hra.nhs.uk), ref: 23/EE/0238
Health condition(s) or problem(s) studiedSelf-harm
InterventionThe COPING intervention is GP-led and consists of eight behaviour change techniques (BCT) aimed at encouraging the young person to use new skills to avoid future self-harm and facilitate GPs to use COPING in daily NHS practice, across two COPING appointments. GPs will be instructed on how to use COPING with young people and will be offered a video demonstration of COPING in prior training. GPs will be recognised after the full delivery of COPING. COPING will be delivered across one face-to-face appointment and the format (face-to-face/remote) of the second appointment will be decided in the first COPING consult. The time (between 2 and 4 weeks) between both COPING appointments will be agreed upon between the GP and the young person.
Intervention typeOther
Primary outcome measure1. Participant consent and willingness of enrolled participants and GPs to be randomised in a future RCT, estimated using rates of consent, participant, and GP self-report from the start of recruitment to the end, including at the 2-month participant follow-up timepoint
2. GP fidelity to COPING delivery and participant adherence to COPING, assessed retrospectively using case report forms and examining the proportion of participants who attend for a second COPING appointment
3. Participant follow-up data collection examined by total completions of the suicidal behaviours questionnaire-revised questionnaire at 2, 4, and 6 months
4. Acceptability of COPING for both participants and GPs, and deliverability of COPING for GPs, assessed using semi-structured interviews and a GP online survey post COPING delivery to end recruitment date
Secondary outcome measuresMeasured from the recruitment start date to the study end date (unless otherwise specified):
1. The response rate of invited general practices to participate, measured throughout the recruitment window
2. Whether GPs can be recruited, trained, and retained to deliver COPING
3. Identification of patients at GP site
4. Proportion of identified patients deemed eligible for inclusion
5. Participant recruitment uptake and baseline characteristics through each recruitment strategy
6. Participant attrition, follow-up, and withdrawal rates
7. Data collection procedures
8. Exploratory effectiveness data via participant-reported patient health questionnaire and suicidal behaviours questionnaire-revised at baseline, 2, 4, and 6 months
Overall study start date01/12/2019
Completion date01/12/2025

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit16 Years
Upper age limit25 Years
SexBoth
Target number of participantsPlanned Sample Size: 39; UK Sample Size: 39
Key inclusion criteriaCurrent inclusion criteria as of 25/07/2024:

General practices who are research active will be invited into the study and those who agree will become a study site.

Participant inclusion criteria:
1. Young people aged 16-25 years
2. History of self-harm (defined by NICE) in the last 12 months
3. Able to give informed consent

_____

Previous inclusion criteria:

General practices who are research active within the NIHR Local CRN West Midlands primary care will be invited into the study and those who agree will become a study site.

Participant inclusion criteria:
1. Young people aged 16-25 years
2. History of self-harm (defined by NICE) in the last 12 months
3. Able to give informed consent
Key exclusion criteriaParticipant exclusion criteria:
1. Acute risk of suicide or harm to others needing urgent referral or admission
2. Moderate to severe learning disabilities
3. Current psychotic episode or organic mental illness
4. Receiving current psychological therapy including NHS talking therapies
5. Unable to provide informed consent
Date of first enrolment01/12/2023
Date of final enrolment01/12/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

NIHR CRN: West Midlands
James House
Newport Road
Albrighton
Wolverhampton
WV7 3FA
United Kingdom

Sponsor information

Keele University
Hospital/treatment centre

Keele
Newcastle-under-Lyme
ST5 5BG
England
United Kingdom

Phone +44 (0)1782 732980
Email research.governance@keele.ac.uk
Website https://www.keele.ac.uk/
ROR logo "ROR" https://ror.org/00340yn33

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/12/2026
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 15/10/2024 28/10/2024 Yes No

Editorial Notes

28/10/2024: Publication reference added.
25/07/2024: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The plain English summary was updated to reflect these changes.
28/12/2023: The target number of participants has been changed from "Planned Sample Size: 31; UK Sample Size: 31" to "Planned Sample Size: 39; UK Sample Size: 39" and the target enrolment updated accordingly.
17/11/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).