A brief intervention for patients in emergency departments who self-harm
| ISRCTN | ISRCTN13472559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13472559 |
| IRAS number | 279991 |
| Secondary identifying numbers | IRAS 279991, CPMS 50572 |
- Submission date
- 16/11/2021
- Registration date
- 18/11/2021
- Last edited
- 30/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In the UK, around 6000 people take their own lives each year, causing suffering to those they leave behind. The risk of suicide is hundreds 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 that 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, an intervention called the ASsuRED approach has been developed to provide support for patients presenting to EDs in the NHS context. This trial will test the clinical and cost-effectiveness of the ASsuRED approach. This trial forms part of a National Institute for Health Research (NIHR) funded research programme. In this trial, the ASsuRED approach will be compared to treatment as usual in approximately 10 EDs and 620 patients.
Who can participate?
Patients aged 18 and over who present to the recruiting Emergency Departments having self-harmed and/or having thoughts of wanting to end their lives.
What does the study involve?
Participants who are identified as eligible for the study will be asked for consent to take part in the study. Participants allocated to the ASsuRED arm will be offered a therapeutic assessment and enhanced safety planning and three follow-up appointments with the same practitioner over 8 weeks, in addition to an optional ‘bank’ session to be taken over the following 9 months and three personalised letters sent over 9 months. Participants in the treatment as usual arm will receive a standard psychosocial assessment. All participants will be asked to complete a research interview at baseline, and then at approximately 3, 9, and 18 months.
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. People also report that talking to researchers can be beneficial.
Where is the study run from?
Devon Partnership NHS Trust (UK) and City, University of London (UK)
When is the study starting and how long is it expected to run for?
November 2021 to January 2027
Who is funding the study?
Programme Grants for Applied Research, National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Alexandra E. Bakou
alexandra.bakou@city.ac.uk
Prof Rose McCabe (scientific)
Rose.McCabe@city.ac.uk
Contact information
Public, Scientific
ASSURED Trial Manager
School of Health Sciences
City University of London
Myddelton Street Building
1 Myddelton Street
London
EC1R 1UW
United Kingdom
 ORCID ID |
0000-0002-4813-7212 |
|---|---|
| Phone | +44 (0)2070405323 |
| alexandra.bakou@city.ac.uk |
Scientific
Myddelton Street Building
1 Myddelton Street
London
EC1R 1UW
United Kingdom
| ORCID ID |
0000-0003-2041-7383 |
|---|---|
| Phone | +44 (0)20 7040 4333 |
| Rose.McCabe@city.ac.uk |
Study information
| Study design | Individual randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | ASsuRED Trial RCT: Improving outcomes in patients who self-harm - Adapting and evaluating a brief pSychological inteRvention in Emergency Departments |
| Study acronym | ASsuRED RCT |
| Study objectives | Current study hypothesis as of 07/02/2024: The ASSURED brief intervention for people attending the emergency department with self-harm will reduce subsequent reattendance to the emergency department for self-harm over 18 months compared with treatment as usual. Previous study hypothesis: A brief intervention compared with treatment as usual for people attending the emergency department with self-harm will reduce subsequent reattendance to the emergency department for self-harm over 18 months. |
| Ethics approval(s) |
Approved 12/11/2021, London - City & East Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, United Kingdom; +44 (0)20 7972 2545; cityandeast.rec@hra.nhs.uk), ref: 21/LO/0683 |
| Health condition(s) or problem(s) studied | Self-harm |
| Intervention | Current interventions as of 07/02/2024: Participants allocated to the ASsuRED arm will be offered a therapeutic assessment, enhanced safety planning and three follow-up appointments with the same practitioner over 8 weeks. In addition, there is an optional fifth bank session that can be taken within 9 months of randomisation and three personalised letters over 9 months. All participants will be asked to complete a research interview at baseline, and then at 3-, 9- and 18-months. The intervention consists of: 1. A narrative interview 2. A safety plan focusing on warning signs of an impending crisis, internal coping strategies, how to change the environment to stay safe, who to contact to resolve a crisis and professional agencies to contact if required 3. Rapid follow-up support: consisting of three follow-up sessions over 8-weeks based on a solution-focused model. The ASsuRED pilot study is registered at https://www.isrctn.com/ISRCTN16003313 Previous interventions: Allocation to the ASsuRED approach or treatment as usual, will depend on the practitioner that patients are allocated to. Participants allocated to the ASsuRED arm will be offered a 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 an 8-week period. Participants in the treatment as usual arm will receive a standard psychosocial assessment. All participants will be asked to complete a research interview after their ED assessment, and then at 3- and 18-months. The intervention consists of: 1. A therapeutic psychosocial assessment using narrative interviewing. The assessment will take approximately 60-minutes, which is the typical duration of assessment delivered in usual care 2. A safety plan focusing on warning signs of an impending crisis, internal coping strategies, how to change the environment to stay safe, who to contact to resolve a crisis and professional agencies to contact if required 3. Rapid follow up support: consisting of a 72-hour phone call and three follow-up sessions over 8-weeks based on a solution focused model. The ASsuRED pilot study is registered at https://www.isrctn.com/ISRCTN16003313 |
| 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 07/02/2024: 1. Self-reported self-harm using online surveys at 1, 2, 3, 9, and 18 months 2. Suicidal ideation measured with the Beck Scale for Suicide Ideation (Beck & Steer, 1993) at baseline, 3, 9 and 18 months 3. Psychological wellbeing measured with CORE-OM (Barkham et al., 2001; Mavranezouli et al., 2011) at baseline, 3, 9 and 18 months 4. Social outcomes measured with the Social Outcomes Index (SIX) (Priebe et al., 2008) at baseline, 3, 9 and 18 months 5. Quality of life measured with the EQ-5D-5L (Herdman et al. 2011) at baseline and 3-, 9-, and 18-months. 6. Psychological wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS, short version) (Tennant et al., 2007) at baseline, 3, 9 and 18 months 7. Experiences of care in Accidents & Emergency Questionnaire, devised for this study, and measured at baseline 8. All cause mortality (including suicide) derived from NHS/local authority/coroner records at 18 months 9. All patient attendances to the Emergency Department at 18 months following the index episode extracted from Trust records 10. Total healthcare use measured using the Client Service Resource Inventory at baseline, 3-, 9, and 18-months and NHS Digital data Previous secondary outcome measures as of 01/02/2022 to 07/02/2024: 1. Self-reported self-harm using online surveys at 1, 2, 3, and 18 months 2. Suicidal ideation measured with Beck's Scale for Suicide Ideation (Beck & Steer, 1993) at baseline, 3, 9 and 18 months 3. Psychological wellbeing measured with CORE-OM (Barkham et al., 2001; Mavranezouli et al., 2011) at baseline, 3, 9 and 18 months 4. Social outcomes measured with the Social Outcomes Index (SIX) (S. Priebe et al., 2008) post-baseline and at 3, 9 and 18 months 5. Quality of life measured with the Warwick-Edinburgh Mental Wellbeing Scales (short version) post-baseline and at 3, 9 and 18 months 6. Experiences of attending the Emergency Department Questionnaire, devised for this study post-baseline 7. Death by suicide, i.e., cause of death is intentional self-harm or undetermined intent derived from NHS/local authority/coroner records at 18 months Previous secondary outcome measures: 1. Self-reported self-harm, using online surveys at 1-, 2-, 3-, and 18-months. 2. Suicide severity, administered by researchers on the Columbia–Suicide Severity Rating scale (Posner et al., 2011) post-baseline and 18-months. 3. Psychological wellbeing measured with CORE-OM (Barkham et al., 2001; Mavranezouli et al., 2011) at baseline, 3- and 18-months. 4. Social outcomes, measured with the Social Outcomes Index (SIX) (S. Priebe et al., 2008) post-baseline and at 3- and 18-months. 5. Quality of Life, measured with the Warwick-Edinburgh Mental Wellbeing Scales (short version) post-baseline and at 3- and 18-months. 6. Experiences of attending the Emergency Department Questionnaire, devised for this study post-baseline. 7. Death by suicide, i.e., cause of death is intentional self-harm or undetermined intent derived from NHS/ local authority/coroner records at 18-months. |
| Overall study start date | 12/11/2021 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 620 |
| Key inclusion criteria | Current key inclusion criteria as of 30/07/2025: 1. ≥18 years of age 2. Presenting to 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 and/or presenting with suicidal ideation, i.e., thoughts of not wanting to live on presenting to the ED with self-harm and/or suicidal ideation, can be admitted for a brief admission to the acute hospital or a brief crisis admission 4. Provide informed consent to take part Previous key inclusion criteria as of 07/02/2024 to 30/07/2025: 1. 16 years of age or older 2. Presenting to 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 and/or presenting with suicidal ideation, i.e., thoughts of not wanting to live 4. On presenting to the ED, can be admitted for a brief admission to the acute hospital Previous key 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 |
| Key exclusion criteria | Current participant exclusion criteria as of 30/07/2025: 1. A current or previous participant of the ASSURED study 2. Patients admitted to a psychiatric hospital 3. Patients receiving input from Child and Adolescent Mental Health Services (CAMHS). Patients receiving service input from CAMHS will be excluded from the date of implementation of Substantial Amendment 5. 4. Patients with cognitive (e.g. dementia) or other psychiatric difficulties interfering with the ability to participate 5. Experiencing a psychotic episode 6. No capacity to provide written informed consent 7. Needing an interpreter 8. Ministry of Justice patients subject to a restriction order 9. Patients receiving intensive psychological input that explicitly precludes them from engaging in other psychological interventions/psychological treatment, e.g. DBT 10. Concerns about safety to practitioner or researcher * 11. Not being registered with a GP 12. Living out of Trust** * Given that the intervention and the researcher meetings are conducted remotely most of the time, please liaise with the local PI about excluding patients for safety-related concerns. **Neighbouring Trusts may be included if agreed with the local PI and documented in the TMF. Planning to move out of the Trust area within ~2 months of enrolling in the study is a reason for exclusion. Previous participant exclusion criteria as of 07/02/2024 to 30/07/2025: 1. Patients admitted to a psychiatric hospital 2. Patients with 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 7. Receiving intensive psychological input e.g. DBT 8. Out of the hospital borough and Trust 9. Concerns about safety to practitioner or researcher 10. Not registered with a GP Previous participant exclusion criteria: 1. Patients admitted to a psychiatric hospital 2. Patients with 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 7. Receiving intensive psychological input e.g. DBT 8. Out of the hospital borough and Trust |
| Date of first enrolment | 21/03/2022 |
| Date of final enrolment | 05/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
E9 6SR
United Kingdom
E11 1NR
United Kingdom
RH1 5RH
United Kingdom
E1 1FR
United Kingdom
CV2 2DX
United Kingdom
CV34 5BW
United Kingdom
CV10 7DJ
United Kingdom
EX2 5DW
United Kingdom
TQ2 7AA
United Kingdom
London
E13 8SL
United Kingdom
Taunton
TA1 5DA
United Kingdom
Yeovil
BA21 4AT
United Kingdom
London
NW1 2BU
United Kingdom
London
N18 1QX
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 | |
| Website | https://www.dpt.nhs.uk/ |
"ROR" |
https://ror.org/04fkxrb51 |
University/education
Myddelton Street Building, 1 Myddelton Street
London
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 | 31/01/2027 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/07/2025: The following changes were made:
1. The completion date was changed from 30/04/2026 to 31/01/2027.
2. The key inclusion and exclusion criteria were updated.
3. The lower age limit was changed from 16.0 to 18.0, and the age group was changed from mixed to adult.
4. The date of final enrolment was changed from 31/10/2024 to 05/12/2024.
5. The recruiting mental health teams were added to the study participating centres.
6. North Devon District Hospital was removed from the study participating centres, and the following were added: Newham University Hospital, Musgrove Park Hospital, Yeovil District Hospital, University College London Hospital & MHCAS, and North Middlesex University Hospital.
7. The intention to publish date was changed from 01/01/2026 to 31/01/2027.
01/05/2024: Contact details updated.
07/02/2024: The following changes were made:
1. The study hypothesis was changed.
2. The study design was changed from "Multicenter cluster randomized trial" to "Individual randomized controlled trial".
3. The secondary study design was changed from "Cluster randomised trial" to "Randomised controlled trial".
4. The overall study end date was changed from 30/04/2025 to 30/04/2026.
5. The interventions were changed.
6. The secondary outcome measures were changed.
7. The participant inclusion criteria were changed.
8. The lower age limit number and unit were added.
9. The age group was changed from adult to mixed.
10. The target number of participants was changed from 1088 to 620.
11. The participant exclusion criteria were changed.
12. The recruitment end date was changed from 31/03/2023 to 31/10/2024.
13. The public contact was changed.
14. The plain English summary was updated to reflect these changes.
03/02/2022: Contact details updated.
01/02/2022: The following changes were made to the trial record:
1. The secondary outcome measures were updated.
2. The recruitment start date was changed from 01/02/2022 to 21/03/2022.
17/11/2021: Trial's existence confirmed by London - City & East Research Ethics Committee
