SafePIT
Research type
Research Study
Full title
The Self-harm, Assessment, Formulation, Engagement Trial of Psychodynamic Interpersonal Therapy (SAFE-PIT)
IRAS ID
301794
Contact name
Else Guthrie
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
Research Summary
We want to find out whether a type of brief therapy, psychodynamic interpersonal therapy (PIT), helps people who attend an emergency department (ED) after an episode of self-harm (SH). We are interested in whether PIT helps people reduce future SH, ED attendance and improve their mental health and quality of life. We will also measure costs and potential cost-savings as this is important for the NHS.
PIT therapy involves 4 weekly sessions and is intended for people who have 3 or fewer SH episodes. People who SH more frequently require more intensive treatment and we have a separate study which will assess a more intensive treatment for this group. Standard care involves a full psychosocial assessment and a care plan.
Mental health nurses who work in EDs will approach people who have attended hospital following SH to see if they are interested in taking part, assuming the study is suitable for them. Those who agree to take part will be allocated by chance to one of 2 groups; PIT as well as standard care or standard care only.We have involved users with experience of SH in designing this study and have a co-applicant who has personal experience of SH and considerable experience of raising awareness and advocating for better mental health care.
The research team has experience of conducting trials of psychological therapies for SH and of running psychological treatment services for people who SH in the NHS.
We will publish the results via academic journals, meetings, and social media. We will target user organisations and will work with our PPI co-applicant to present information in a clear format. Several of us have national roles which will enable the results (if favourable) to be fast-tracked into national policy, one of the best ways of making the treatment available on the NHS.
Summary of Results
We set up this research trial to find out whether a brief type of therapy, psychodynamic-interpersonal therapy (PIT) helps people who attend an emergency department (ED) after an episode of self-harm, over and above NHS standard care. We were interested in finding out whether PIT helps people reduce future self-harm, attendance at hospital and improves mental health and quality of life.
Intentional non-fatal self-harm usually involves taking an overdose of tablets, cutting or burning. People who self-harm are emotionally distressed and have a high risk of ending their lives. Nearly 9 out of 10 episodes of self-harm are triggered by relationship problems. Most people who attend hospital following self-harm are not offered any psychological therapy. SafePIT involves 4 weekly sessions of one-to-one therapy and is intended for people who have three or fewer prior episodes of self-harm. People who self-harm more frequently require a more intensive treatment. Standard care involves a full psychosocial assessment and a care plan.We planned that mental health nurses who work in EDs and assess people who self-harm would approach people to see if they would be interested in taking part in the trial. A local researcher would then discuss the trial in more detail, with the interested person, and if they were suitable for the study, consent them to the study. We planned to involve 12 different EDs around England in the full trial and recruit 770 people.
We started the trial in February 2022 just after the height of the OMICROM wave of the COVID-19 pandemic. We found it extremely difficult to recruit people to the study due to a variety of factors, but the most important one was the impact of the COVID-19 pandemic on clinical services and also research support services. It took us a long time to set up hospital sites. We had planned to open 6 in the first 12 months and although we achieved this, there were many delays. At the hospital sites, the mental health teams suffered from high rates of staff turnover and sickness absence. There was low morale and staff (both clinical and research) at times did not have the capacity to recruit people to the study.
Despite our best efforts to overcome these problems, it became clear that we would not be able to complete the study and we agreed with the funders to close the trial after 12 months. In total we recruited 22 participants. It is not possible from the small number of people we recruited to make any judgements about the helpfulness of PIT for people who self-harm. We hope that future research in this area will be able to learn from the difficulties that we encountered.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0204
Date of REC Opinion
13 Oct 2021
REC opinion
Further Information Favourable Opinion