A brief psychological intervention for self-harm in Emergency Departments
| ISRCTN | ISRCTN16003313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16003313 |
| IRAS number | 257373 |
| Secondary identifying numbers | 3.0, IRAS 257373 |
- Submission date
- 27/01/2020
- Registration date
- 04/02/2020
- Last edited
- 18/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
In the UK, around 6000 people take their own life each year, causing suffering to those they leave behind. The risk of suicide is 100s of times greater among people who self-harm than among the general population, with 15-43% of people attending the Emergency Department (ED) with self-harm in the year before death. For this reason, the Government’s Suicide Prevention Strategy has identified those presenting with self-harm as a priority group. Each year, around 220,000 episodes of self-harm by 150,000 people are managed by EDs in England. Most EDs have a psychiatric liaison team of specialist mental health practitioners who conduct psychosocial assessments to engage patients, assess their current and future health and social care needs and make onward referrals. However, assessments are often inadequate due to limited capacity in these services and patients often not attending or dropping out, emphasising the need for effective intervention. An appropriate brief intervention which changes routine meetings with patients in the ED could reach around 220,000 patient contacts each year in England. Evidence from recent international trials indicates that such interventions delivered by specialist mental health practitioners in EDs are effective in reducing self-harm and suicide. Training existing mental health teams to deliver the intervention would be relatively cheap, making wider rollout in the NHS attractive. Based on existing international evidence and feedback from all stakeholders, this study aims to pilot the intervention across four Emergency Departments in England. This pilot study forms part of a National Institute for Health Research (NIHR) funded research programme. In this pilot study, the intervention will be tested at four EDs around London, with 16 practitioners and 96 patients. Feedback will be collected on the intervention from patients, carers and practitioners, so that we can learn about potential barriers to implementation and this will lead to further development of the intervention. Assuming the pilot study is successful and acceptable to participants, the next phase will be a large scale cluster randomized controlled trial across 26 Emergency Departments in England.
Who can participate?
Patients aged 16 and over who present to the recruiting Emergency Departments having self-harmed.
What does the study involve?
Participants who are identified as eligible for the study will be offered an adapted therapeutic assessment and enhanced safety planning with the practitioner they see in the Emergency Department. They will then be offered three follow up appointments with the same practitioner over a three-month period. A six-month outcome assessment will then be carried out. Interviews will be carried out with patients, carers and practitioners, to inform the ongoing development of the intervention, in preparation for a future cluster randomized controlled trial.
What are the possible benefits and risks of participating?
Participating in a study whilst people are in distress may present a risk of further distress to people who are emotionally vulnerable. If the practitioners or the researchers feel that the research is too overwhelming, they will stop the process immediately. Our Lived Experience Advisory Panel (LEAP), confirmed that while there is the possibility of causing additional distress, participating in the study may also be beneficial to patients as it may help people feel that they are contributing and are able to help improve services. There are also benefits in terms of being able to talk and being listened to.
Where is the study run from?
1. Newham University Hospital (UK)
2. St Helier Hospital (UK)
3. East Surrey Hospital (UK)
4. Royal London Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2020 to July 2025
Who is funding the study?
Programme Grants for Applied Research, National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Sally O'Keeffe (public)
Sally.OKeeffe@city.ac.uk
Prof Rose McCabe (scientific)
Rose.McCabe@city.ac.uk
Contact information
Public
Myddelton Street Building
1 Myddelton Street
London
EC1R 1UW
United Kingdom
 ORCID ID |
0000-0002-6713-2898 |
|---|---|
| Phone | +44 (0)2070405323 |
| Sally.OKeeffe@city.ac.uk |
Scientific
Myddelton Street Building
1 Myddelton Street
London
EC1R 1UW
United Kingdom
| Phone | +44 (0)20 7040 4333 |
|---|---|
| Rose.McCabe@city.ac.uk |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | ASsuRED pilot: Improving outcomes in patients who self-harm - Adapting and evaluating a brief pSychological inteRvention in Emergency Departments |
| Study acronym | ASsuRED pilot |
| Study hypothesis | This study aims to address four research questions: 1. Can practitioners implement a brief psychological intervention to patients presenting in the Emergency Department to improve care in routine practice in the NHS? 2. What barriers and facilitators to implementing the intervention are experienced by practitioners, patients and carers? 3. Is it feasible for patients to rate outcome measures in the Emergency Department setting for a randomized controlled trial? 4. What are the main resources involved in implementing the intervention? |
| Ethics approval(s) | Approved 27/07/2019, London - Surrey Borders Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)207 104 8134; NRESCommittee.London-SurreyBorders@nhs.net), ref: 19/LO/0778 |
| Condition | Self-harm |
| Intervention | The ASsuRED pilot study is a single-arm trial taking place across four sites. Participants who present to Emergency Departments having self-harmed will be recruited and will be offered a brief psychological intervention. The intervention will be delivered by practitioners in liaison psychiatry teams, who currently offer a risk assessment to patients. The practitioners will be trained to deliver a therapeutic risk assessment with enhanced safety planning, with follow up care after the patient leaves the Emergency Department. The patient will receive a phone call within 72-hours of leaving the Emergency Department, and three follow-up meetings at 1, 4 and 8 weeks, which will be based on a solution-focused approach to supporting the patient. Follow up contact will be offered by the same practitioner that the patient met in the Emergency Department. Longer-term contact over 9-months will be offered through regular letters from the practitioner. Sixteen practitioners will implement the intervention with up to 6 patients each providing 96 practitioner-patient dyads. Practitioners will be trained in delivering the intervention. Identified barriers to implementation and feedback on outcomes will be collected and synthesised to guide refinement of the intervention, and this data will be collected using interviews with patients, carers and practitioners. Updated 28/05/2021: Sixteen practitioners will implement the intervention with patients and we will recruit 60 practitioner-patient dyads. Practitioners will be trained in delivering the intervention. Identified barriers to implementation and feedback on outcomes will be collected and synthesised to guide refinement of the intervention, and this data will be collected using interviews with patients, carers and practitioners. |
| Intervention type | Behavioural |
| Primary outcome measure | Repeat self-harm identified by searching Emergency Department electronic records at the end of the study |
| Secondary outcome measures | Current secondary outcome measures as of 28/05/2021: At baseline and 6 months follow up: 1. Therapeutic relationship, self-rated by patients on the Helping Alliance Scale 2. Self-reported self-harm 3. Suicide severity from the Columbia–Suicide Severity Rating scale 4. Social outcomes from the Social Outcomes Index (SIX) 5. Quality of Life measured with the Manchester Short Assessment of Quality of Life (MANSA) 6. Psychological distress measured with Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) 7. Experiences of attending accident & emergency measured using the experiences of attending accident & emergency questionnaire 8. Death by suicide, i.e. cause of death is intentional self-harm or undetermined intent, derived from NHS/local authority/coroner records Previous secondary outcome measures: At baseline and 6 months follow up: 1. Therapeutic relationship, self-rated by patients on the Helping Alliance Scale 2. Self-reported self-harm 3. Suicide severity from the Columbia–Suicide Severity Rating scale 4. Beck Depression Inventory 5. Beck Hopelessness Scale 6. Quality of life measured with CORE-OM 7. Death by suicide, i.e., cause of death is intentional self-harm or undetermined intent derived from NHS/ local authority/coroner records |
| Overall study start date | 01/05/2019 |
| Overall study end date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 62 |
| Participant inclusion criteria | 1. >16 years of age 2. Presenting in the ED 3. Presenting with self-harm, i.e., an intentional act of self-poisoning or self-injury, irrespective of the motivation or apparent purpose of the act 4. On presenting to the ED, can be admitted for a brief admission to the acute hospital |
| Participant exclusion criteria | 1. Admitted to a psychiatric hospital 2. Cognitive (e.g. dementia) or other psychiatric difficulties interfering with ability to participate 3. Experiencing a psychotic episode 4. No capacity to provide written informed consent 5. Needing an interpreter 6. Ministry of Justice patients subject to a restriction order |
| Recruitment start date | 04/02/2020 |
| Recruitment end date | 31/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Plaistow
London
E13 8SL
United Kingdom
Carshalton
SM5 1AA
United Kingdom
Redhill
RH1 5RH
United Kingdom
David Hughes Building
Stepney Way
London
E1 1FR
United Kingdom
Sponsor information
Hospital/treatment centre
Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
England
United Kingdom
| Phone | +44 (0)1392 674114 |
|---|---|
| tobit.emmens@nhs.net | |
"ROR" |
https://ror.org/04fkxrb51 |
University/education
Myddelton Street Building
1 Myddelton Street
Clerkenwell
EC1R 1UW
England
United Kingdom
| Phone | +44 (0)20 7040 5704 |
|---|---|
| a.welton@city.ac.uk | |
| Website | http://www.city.ac.uk |
|
"ROR" |
https://ror.org/04489at23 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 8.0 | 13/08/2021 | 16/09/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
18/09/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 05/11/2021 to 31/01/2023.
2. The overall study end date was changed from 01/06/2022 to 31/07/2025.
3. The intention to publish date was changed from 30/09/2023 to 31/07/2026.
18/07/2023: The intention to publish date was changed from 30/11/2022 to 30/09/2023.
16/09/2022: Protocol file uploaded.
16/11/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/11/2021 to 05/11/2021.
2. The overall trial end date was changed from 01/05/2022 to 01/06/2022.
3. Total final enrolment number added.
4. The scientific title was changed from "ASsuRED: Improving outcomes in patients who self-harm - Adapting and evaluating a brief pSychological inteRvention in Emergency Departments" to "ASsuRED pilot: Improving outcomes in patients who self-harm - Adapting and evaluating a brief pSychological inteRvention in Emergency Departments"
5. The acronym was changed from ASsuRED to ASsuRED pilot.
06/10/2021: The recruitment end date has been changed from 30/09/2021 to 03/11/2021.
28/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2020 to 30/09/2021.
2. The overall trial end date was changed from 01/05/2021 to 01/05/2022.
3. The target number of participants was changed from 96 to 60.
4. The interventions, secondary outcome measures and trial website were updated.
5. The trial participating centres were updated to remove St Peter Hospital and add Royal London Hospital.
6. The intention to publish date was changed from 30/11/2021 to 30/11/2022.
29/01/2021: The recruitment resumed.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
03/02/2020: Trial’s existence confirmed by London - Surrey Borders Research Ethics Committee.
