A new psychological therapy called CARMS is being tested in a clinical trial with 333 NHS patients who have psychosis and are currently experiencing suicidal thoughts, to see if it can reduce those thoughts and prevent suicide attempts. Suicide is a leading cause of premature death in people with psychosis, yet no psychological therapy has been specifically designed to target suicidality in this group. Existing treatments focus on psychotic symptoms like delusions, not on the feelings of defeat, entrapment, and hopelessness that drive suicidal thinking. The CARMS therapy directly addresses these underlying psychological mechanisms by teaching patients practical techniques for emotional regulation, problem-solving, and using social support. If the trial shows CARMS therapy reduces suicidal thoughts and intent, it would provide the first evidence-based psychological intervention for suicide prevention in psychosis. The therapy is designed to be deliverable within NHS mental health services, and the trial includes a qualitative component exploring how patients and clinicians view its implementation. Success could change clinical guidelines and give community mental health teams a concrete tool to reduce suicide risk in a vulnerable population.
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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.
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