Title: A psychological intervention for suicide applied to patents with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)
Funder: Department of Health and Social Care

Abstract: Efficacy aim: To investigate the efficacy of a purposely designed psychological CARMS therapy in reducing suicidality when delivered to patients with psychosis, upon therapy cessation and at 12 months follow-up (FU). We predict that suicidal thoughts will be less severe and less frequent in the treatment compared to the control condition, and that these effects will endure. Mechanism aims: To investigate i) psychological suicide mechanisms focusing on negative appraisals, and ii) whether our therapy changes these mechanisms. We predict that negative appraisals of emotion coping, social support and problem solving will lead to feeling defeated, trapped and hopeless, which will in turn lead to suicidality. Implementation aim: to explore patients', health care professionals', and service providers' views of implementing our therapy. Design and assessments: This is a 2 armed parallel RCT with 2 conditions of treatment (our CARMS therapy plus Treatment As Usual [TAU]) versus control (TAU only). All participants will be screened for psychosis and current suicidality. Assessments will be at baseline, on therapy cessation (6 months) and at 12 months follow-up (FU). Population: Community patients using NHS mental health services for psychosis (e.g., schizophrenia spectrum disorders). Intervention: Our therapy aims to improve negative appraisals. It is formulation based but guided by 5 components, the first of which is engagement and the last concerns "keeping-well". Practical techniques addressing negative appraisals of problem solving, emotional regulation, and social support are targeted by the intervening components. Outcomes: The primary outcome is suicidal thoughts which are the first stage in the suicide continuum. Secondary outcomes assess suicide intent and acts. Mechanistic variables test negative appraisals and perceptions of defeat, entrapment and hopelessness. Sample size and statistics: We require 125 people per group to have 80% power to detect an effect size of 0.36. To account for 25% attrition at the final FU, we will recruit 333 patients at baseline. Our calculations account for clustering, therapist numbers, and a 1:1 random allocation, at p=.05. We expect that 50% of patients will decline to take part. Hence, 666 patients will be screened. This means screening 133 patients in each of 5 NHS sites. We estimate that 12,465 patients will meet our inclusion criteria based on the current standing case-load, confirmed by the CRN. We will recruit 3 groups of up to 25 people for the qualitative work: 2 groups of patients from each arm of the trial; and 1 group of health professionals and service providers. Stages and recruitment rate over 48 months: Stage 1:0-6 months – hiring of staff, finalising ethical approval, finalising standard operating procedures and protocols. Stage 2:Screening, recruitment, and on-going FU 7-36 months.

Lay abstract: What is the proposed research? Around 6% of people with psychosis die by suicide. Many more think about it and harm themselves. Talking therapies for people with psychosis focus on psychosis symptoms and do not stop people having ideas about suicide or carrying them out. Our team designed a talking therapy (called CARMS) to reduce suicidal thoughts in people with psychosis. Studies show that many people with psychosis feel isolated, unable to cope with their emotions, or fix their problems. This makes them feel hopeless, trapped and defeated. CARMS aims to help people find practical ways to deal with their problems and change how they view themselves. Our past research showed that therapists can use CARMS to help people with psychosis, and those people said that they found CARMS worthwhile. Now we must answer two important questions: Does CARMS help people change their thinking to reduce suicidality? How well does CARMS work in practice in the NHS? How does this research answer these questions? We propose a study comparing two groups of people with psychosis who use NHS mental health services. One group will carry on with their usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus their usual treatment. A computer will decide randomly which group someone goes into. We will see whether suicidal ideas, plans, and acts are less common in the people offered CARMS compared to the other group. We will also ask both groups whether they still feel alone, unable to cope with their emotions, unable to fix their problems, trapped, defeated and hopeless. We will check after 12 months to see if our CARMS therapy still makes a difference. How and where will the research be carried out? The Universities of Manchester and Lancaster will work with 5 NHS trusts in the Northwest to find people who could take part. The study will take 4 years, and will employ 5 therapists, 6 research assistants and 2 more senior researchers. We would like 250 people to take part. What are the ethical problems? People who take part may be at a very difficult time in their lives and it is important that we do not make things any worse. Our team has worked for many years with clinical teams to find people who could take part and we will ensure that the right support is in place for people who participate. All researchers and therapists will have intensive support and training to ensure they can do this. Also, all participants will be contacted by phone 24 hours after completing any assessments to check how they are feeling. Past research shows that neither CARMS therapy nor asking about suicidal thoughts causes people to think about suicide more often or harm themselves. We also realise how important it is that people know exactly what the research involves and that they can change their mind about doing it at any time. We will not recruit people whom clinical teams judge too unwell to take part in our study nor will we involve those who do not have capacity to consent. Why is the team well placed to do this research? The team’s psychologists, statisticians and psychiatrists have years of experience of running clinical trials involving psychosis, of developing therapies, and of research into suicide.

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