Title: Assessing psychological support for people with emotional distress and difficulties in relationships: The SPS study.
Funder: Department of Health and Social Care

Abstract: People with personality disorder experience high levels of emotional distress, which can lead to problems in relationships, suicidal behaviour and social exclusion. People with these difficulties have high levels of contact with health services but the care they receive is often poor. They may be prescribed large amounts of psychiatric medication, even though none are licensed for this condition. National guidelines recommend that people are offered evidence-based psychological treatments. These last between one and two years and require people to attend therapy groups on a regular basis. Some people with personality disorder are considered unsuitable for these intensive treatments, and many who are offered them decide not to attend or drop out of treatment before it is completed. _x000D_ _x000D_ In an effort to provide services that are more inclusive and to increase the number of people with personality disorder that receive effect treatment, clinicians have begun to develop lower intensity treatments. However, we do not have good quality evidence about whether they help patients in the long term or provide value for money. _x000D_ _x000D_ Structured Psychological Support (SPS) is an individual low intensity intervention, which was developed in collaboration with people with lived experience of personality disorder. It consists of six to ten sessions of person-centred psychological support and aims to help people develop a better understanding of their difficulties and techniques that they can use to improve their mental health and functioning. A recent study showed that it is possible to conduct a clinical trial of this intervention. Feedback from patients who received the intervention was positive and we found that patients had improved functioning and greater satisfaction with care. _x000D_ _x000D_ We are a group of researchers, clinicians and an Expert by Experience who have designed a study to see if SPS works and find out if it provides value for money for the NHS. Patients will be recruited from primary and secondary care mental health services in the North West, South West and South East of England, and randomised to either SPS or to recommended treatment as usual. We will compare the effects that SPS and treatment usual treatment have on people’s relationships, work and other activities, mental health, self harm and quality of life as well as the cost of care they receive. We will also interview patients and clinical staff to find out more about if and how SPS helps people, and how best to deliver it. _x000D_ _x000D_ We will continue to work with people with lived experience of personality disorder to ensure that the study is acceptable and that patient experience guides the way we conduct the study and tell people about the study findings. We will present the results of this research through papers in journals, presentations at conferences and through social media. We will work with colleagues in NHS England to ensure that the results of the study change service provision._x000D_ _x000D_ This study has the potential to greatly improve the health and quality of life of people with this common and life-limiting condition. _x000D_ _x000D_ If shown to be effective, SPS could substantially increase the number of people with personality disorder who receive evidence-based care. If the results are negative, they will bring into question the increasing use of untested low intensity interventions and focus attention on improving the availability and acceptability of higher intensity treatments.

Lay abstract: RESEARCH QUESTION_x000D_ Among people with probable personality disorder, does Structured Psychological Support (SPS) compared to enhanced treatment as usual lead to improved health and social functioning over the following year?_x000D_ _x000D_ BACKGROUND _x000D_ The only treatments that are currently recommended by NICE for people with personality disorder are lengthy and highly intensive, which many people are unable or unwilling to use. Low intensity interventions may be more acceptable and inclusive, but evidence on their effectiveness is missing. _x000D_ _x000D_ AIMS AND OBJECTIVES _x000D_ To conduct a fully-powered, pragmatic, randomised controlled trial, to investigate the clinical effectiveness and cost-effectiveness of SPS for people with personality disorder and generate a contextualised analysis of intervention delivery and outcome generation. _x000D_ _x000D_ METHODS _x000D_ Multicentre, researcher-masked, RCT, including an integrated pilot phase, a parallel process evaluation and an economic evaluation. We will recruit people aged 18 or over with probable personality disorder from primary and secondary care mental health services in five NHS Trusts in England. We will exclude those who are unable or unwilling to provide written informed consent, have a co-existing organic or psychotic mental disorder, are already receiving psychological treatment for personality disorder, or are on a waiting list for it. _x000D_ Health technologies: SPS is an individual intervention delivered over six to 10 sessions, which uses techniques drawn from evidence-based high-intensity treatments. All those in the control arm of the trial will receive enhanced treatment as usual from mental health services, that ensures they have a current care plan and crisis plan. _x000D_ Study outcomes: Our primary outcome is social functioning measured over 12 months using the Work and Social Adjustment Scale (WSAS). Secondary outcomes are mental health, suicidal behaviour, health-related quality of life, patient-rated global improvement and satisfaction with care, six and 12 months after randomisation. We will concurrently assess resource use and costs from an NHS/PSS perspective using a modified version of the Adult Service Use Schedule. _x000D_ Sample size: Data from 215 participants (115 receiving SPS and 100 receiving enhanced TAU) are needed to have 90% power to detect a 3.8 point (SD = 9.5) minimum clinically important difference in WSAS at 12 months, using a 0.05 level of statistical significance. To take account of 30% loss to follow-up we will recruit 308 subjects._x000D_ Process evaluation: Analysis of quantitative data on uptake of interventions and qualitative data from 40 clinicians and managers, 24 participants in the full trial and 20 participants and non-participants during the pilot phase of the trial. _x000D_ Analysis: ITT analysis using a general linear mixed model adjusted for baseline score, allocation group and study centre. _x000D_ _x000D_ TIMELINES FOR DELIVERY_x000D_ 32 months in total. Start date 01.04.22. Start of recruitment (pilot phase) - month 10. Recruitment in the full trial - month 14 to 17. Anticipated rate of recruitment = 38.5 participants per month. Follow up until month 29. Final report submitted month 32._x000D_ _x000D_ DISSEMINATION_x000D_ Papers, reports, presentations, messaging though social media and a webinar aimed at users, providers and commissioners of mental health services._x000D_ _x000D_ IMPACT_x000D_ Substantial increase in the number of people with personality disorder who receive effective evidence-based treatment.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH