Can a brief relational talking therapy help adults who self-harm?
| ISRCTN | ISRCTN75661422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75661422 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 318068 |
| Protocol serial number | CPMS 54183, IRAS 318068 |
| Sponsor | Greater Manchester Mental Health NHS Foundation Trust |
| Funder | National Institute for Health and Care Research Central Commissioning Facility (CCF); Grant Codes: NIHR203515 |
- Submission date
- 18/10/2022
- Registration date
- 21/10/2022
- Last edited
- 11/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Self-harm refers to when a person intentionally harms themselves, for example by cutting themselves or taking an overdose. Self-harm can occur both with and without suicidal intent. Research suggests that in the UK rates of self-harm have increased. It is a major health concern because self-harm is associated with a greater risk of suicide and emotional distress. Evidence of which therapies are most helpful for people who self-harm is limited. Some therapies that are currently used are also very intensive (e.g. Dialectical Behaviour Therapy), can be difficult to access, and do not suit everybody. Cognitive Analytic Therapy (CAT) is a talking therapy that has the potential to help people who self-harm. It may provide a helpful alternative for people struggling with self-harm that may not be eligible for or able to access other therapies. Before a large-scale clinical trial of CAT for self-harm can be undertaken, it is helpful to conduct a smaller-scale feasibility trial. The aim of the current study is therefore to undertake a feasibility study of CAT for adults who self-harm. Data will be collected to help answer important feasibility uncertainties (e.g. can we recruit an adequate sample).
Who can participate?
Adults with experiences of self-harm from NHS mental health services, including IAPT (Improving Access to Psychological Therapy) services and other community-based mental health services
What does the study involve?
Participants will first be asked to complete a baseline assessment with a researcher, answering questions about their thoughts, feelings, and recent difficulties. Participants will then be randomly put into one of two groups. One group will receive the therapy, CAT, plus the usual treatment. The other group will just have access to their usual treatment. There will be further meetings with the researcher to do more assessments at 12 and 18 weeks after being put into the group. Some participants will also be invited to take part in a more in-depth interview or complete additional questionnaires online, but these parts of the study are optional. We are hoping to recruit 60 people to take part overall.
What are the possible benefits and risks of participating?
We do not yet know how helpful CAT will be for people who self-harm, which is why we are doing this research. Taking part in research can be an interesting and rewarding experience though. Taking part in this study will help us better understand which treatments might help people who self-harm. Taking part may therefore feel like a positive experience for some people and a way to help others. The study will involve being asked questions about difficult experiences like self-harm, and this may be uncomfortable to distressing for some people. Participants will not have to answer any questions they do not wish to and will be able to leave the study at any time. The researchers will be trained to respond to distress and will be able to offer breaks during meetings and provide advice on further sources of support.
Where is the study run from?
The lead site is the study is Greater Manchester Mental Health and Social Care NHS Foundation Trust. The second site is at Rotherham, Doncaster, and South Humber NHS Foundation Trust
When is the study starting and how long is it expected to run for?
December 2022 to December 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Peter Taylor (Project lead), peter.taylor-2@manchester.ac.uk
Dr Stephen Kellett, Stephen.kellett@nhs.net
Contact information
Scientific
University of Manchester
Division of Psychology & Mental Health
Zochonis building
Room 2.28
Brunswick Park
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0003-1407-0985 |
|---|---|
| Phone | +44 (0)1613060425 |
| Peter.taylor-2@manchester.ac.uk |
Scientific
Grounded Research
2 St Catherine’s Close
Tickhill Road Hospital site
Balby
Doncaster
DN4 8QN
United Kingdom
| Stephen.kellett@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized interventional study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Relational Approach to Treating Self-Harm (RelATe): a feasibility study of cognitive analytic therapy for people who self-harm |
| Study acronym | RelATe |
| Study objectives | As this is a feasibility trial we have progression criteria rather than hypotheses. These are outlined below. A traffic light system (Green = progress to definitive trial; Amber = modification needed; Red = do not progress) has been adopted to guide the decision to progress: 1. Recruitment rates: Data on the ability to randomise 60 participants within 12 months (5 participants per month). Green: ≥80%. Amber: 60-79%. Red: ≤59%. 2. Retention rate (completion of end-of-treatment follow-up assessments). Green: ≥80%. Amber 60-79%. Red ≤59%. 3. Missing data on primary outcomes at assessment. Green: <15%. Amber: 16-25%. Red >25%. 4. Adherence to treatment: Percentage of participants receiving the minimum dose of therapy (≥4 sessions) within a 10-week treatment window. Green: ≥80%. Amber: 60-79%. Red: ≤59%. |
| Ethics approval(s) | Approved 07/11/2022, Greater Manchester West Research Ethics Committee (Barlow House, 3rd Floor, HRA NRES Centre Manchester, M1 3DZ, UK; +44 (0)207 104 8379; gmwest.rec@hra.nhs.uk), ref: 22/NW/0317 |
| Health condition(s) or problem(s) studied | Mental health |
| Intervention | Cognitive Analytic Therapy (CAT) will be delivered by a qualified band 7 or 8 practitioner with appropriate core professional training (e.g., clinical psychologist) who has undertaken additional training in CAT (completing at least the first year of post-qualification CAT practitioner training). Therapists will be supervised by an accredited CAT therapist on a fortnightly basis. The therapy will follow a standard eight-session CAT model, with a specific focus on self-harm as the presenting problem. Sessions 1-3 would typically focus on developing a shared understanding of difficulties and identifying unhelpful patterns that maintain problems, using visual (drawn) mapping of experiences and therapeutic letters to assist in this process. Sessions 4-8 would typically focus on the recognition of unhelpful patterns identified so far, and the use of alternative, more helpful ways of responding to experiences and challenges, referred to as “exits”. A further follow-up session will take place up to 8 weeks after the end of therapy, based on recommendations from Patient and Public Involvement (PPI) meetings. Therapy sessions will last 50 to 60 minutes and typically occur weekly. Based on recommendations from PPI contributors, sessions could be undertaken either in person or remotely via a video call. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured using patient records: |
| Key secondary outcome measure(s) |
1. Self-harm measured with the Self-Injurious Thoughts and Behaviours Interview-Short Form (SITBI) at baseline, 12 weeks, and 18 weeks |
| Completion date | 11/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Three or more episodes of self-harm in the past year, confirmed via the Self-Injurious Thoughts and Behaviours Interview 3. Can be safely seen in an outpatient clinical context in which treatment is being provided as judged by their clinical team or referrer |
| Key exclusion criteria | 1. Participants will be excluded if they have a moderate-to-severe intellectual disability (IQ:< 70) affecting their eligibility for community mental health services as judged by their clinical team or referrer 2. Organic cerebral disease/injury affecting receptive and expressive language comprehension as judged by their clinical team 3. Non-English speaking to the degree that the participant is unable to answer questions and give written informed consent 4. Imminent and immediate risk to self or others, operationalised as the presence of active suicidal intent or planning to end one's life in the near future (e.g. next week). Where individuals are excluded on this basis, with the person’s consent, the researcher will aim to recontact them and the referrer in approximately one month’s time (or a time period agreed upon in collaboration with the individual) to determine if the risk has subsided to a point where they are now eligible. 5. Currently an inpatient 6. Experiencing a current, active episode of psychosis or mania 7. Currently receiving another active one-to-one psychological therapy |
| Date of first enrolment | 13/02/2023 |
| Date of final enrolment | 29/02/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Prestwich
Manchester
M25 3BL
United Kingdom
Tickhill Road
Doncaster
DN4 8QN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. The decision on which repository to use has not yet been made but will be reviewed as the trial progresses. Qualitative data will not be shared due to the greater challenges in fully anonymising such data. Data will be made available to other researchers to access once the main trial results have been published. Participants will be informed that data may be shared in this way. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 18/07/2024 | 19/07/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 11/12/2024 | 11/12/2024 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN75661422_Summary Results.pdf
- Other unpublished results
Editorial Notes
11/12/2024: Summary results added.
04/12/2024: The contact confirmed the record is up to date.
19/07/2024: Publication reference added.
10/04/2024: Total final enrolment added.
12/02/2024: The recruitment end date was changed from 01/02/2024 to 29/02/2024.
10/02/2023: The recruitment start date was changed from 01/02/2023 to 13/02/2023.
08/11/2022: The following changes were made to the trial record:
1. The ethics approval was added.
2. A contact was added.
18/10/2022: Trial's existence confirmed by NIHR.
