Gooding, Patricia and Awenat, Yvonne and Drake, Richard and Emsley, Richard and Jones, Steven and Kapur, Navneet and Lobban, Fiona and Peters, Sarah and Pratt, Daniel and Elliott, Rachel and Boardman, Bradley and Camacho, Elizabeth and Edwards, Danielle and Harris, Kamelia and Huggett, Charlotte and Haddock, Gillian (2026) A psychological talking therapy for suicidality in people experiencing non-affective psychosis : Mechanism and efficacy outcomes of the CARMS (Cognitive AppRoaches to coMbatting Suicidality) randomised controlled trial. Efficacy and Mechanism Evaluation, 13 (3). pp. 1-71. ISSN 2050-4373 (In Press)
Full text not available from this repository.Abstract
Background Suicide is a leading cause of death worldwide, particularly in people with severe mental health problems, including schizophrenia. The development, and testing, of suicide-focused psychological interventions which can combat suicidal experiences is an unrealised necessity. However, it is vital that suicide-focused therapies are derived from robust, evidence-based mechanistic suicide theories. The Schematic Appraisals Model of Suicide is one such theory. Objective(s) The Cognitive AppRoaches to coMbatting Suicidality project had two objectives. First, based on the Schematic Appraisals Model of Suicide, to test psychological pathways underlying suicidal thoughts, plans and attempts. Second, to test the efficacy of Cognitive–Behavioural Suicide Prevention for psychosis, a suicide-focused intervention developed by our team. Design The randomised controlled trial had two groups: our suicide-focused therapy, Cognitive–Behavioural Suicide Prevention adapted Cognitive–Behavioural Suicide Prevention for psychosis, plus treatment as usual (treatment) versus treatment as usual only (control). There were three assessment time points of baseline, 6 and 12 months, with the 6-month time point being the critical point for the main primary outcome. Four qualitative methods workstreams were nested within the randomised controlled trial design. Settings Four National Health Service Trust sites in the North West of England, United Kingdom: Greater Manchester Mental Health NHS Foundation Trust, Pennine Care NHS Foundation Trust, Lancashire and South Cumbria NHS Foundation Trust, and the former North West Boroughs Healthcare NHS Foundation Trust. Participants Main inclusion criteria: (1) non-affective psychosis (e.g. schizophrenia), (2) suicidal experiences in the 3 months prior to recruitment; (3) under the care of an National Health Service mental health services team and (iv) aged 18 or over. Main outcome measures The primary outcome measure was the Adult Suicidal Ideation Questionnaire, which measures suicidal ideation severity over the past month using 25 self-report items. The 6-month follow-up assessment point was the critical time point. There were two secondary suicide measures. Mechanism measures captured six appraisals of emotional difficulties, lack of social support, interpersonal problem-solving difficulties, defeat, entrapment and hopelessness. Results Recruitment ensued from on 21 June 2017 and lasted until 25 November 2020. The last 12-month follow-up assessment was completed on 10 January 2022. Two hundred and ninety-two participants were randomly allocated to the treatment ( N = 149) and control ( N = 143) groups. Reductions in suicidal ideation severity were not significantly greater in the treatment compared to the control group ( p = 0.07; 95% confidence interval −15.41 to 0.68) at month 6. There were, similarly, no significant treatment effects for the secondary suicide outcomes. A therapy ‘dose–response’ showed that each therapy session reduced the suicidal ideation severity score by 0.46, but this effect was also not significant ( p = 0.056; 95% confidence interval −0.94 to 0.01), nor was a compliance-adjusted analysis in which only participants who attended at least one session of therapy were included ( p = 0.052; 95% confidence interval −0.39 to 0.00). However, a predicted mediation pathway was statistically significant for one of the six mechanism measures, in which the therapy group relative to the control group improved social support appraisals, which, in turn, reduced suicidal ideation severity at month 6 (effect = −2.85, 95% confidence interval −7.00 to −0.23). Qualitative and mixed-methods findings showed that (1) feelings of not mattering, disconnection and irrelevance were central to suicidal thoughts, (2) it is vital to develop better ways of communicating about suicide, (3) our suicide-focused therapy was acceptable and feasible and (4) that being part of suicide work in a trial was largely a positive experience. Limitations The sample was predominantly White/Caucasian and conducted in one geographical United Kingdom location, the primary outcome measure captured only suicidal thought severity, and there were only two follow-up time points. Conclusions This suicide-focused psychological intervention did not demonstrate a treatment effect in the primary suicide outcome measure at month 6 at the 5% significance threshold. There was also no significant treatment effect for secondary suicide outcomes. Future work Research programmes founded on convergent methods, and evidenced-based psychological suicide models are needed to examine how to bolster appraisals of poor social support, disconnection, and not mattering in the context of suicidal mind-sets, and in tandem with the development of creative and inclusive communication tools to relay suicidal experiences. In addition, exploration of the role of ‘dose’ of therapy is crucial for further treatment development. Trial registration This trial is registered as ClinicalTrials.gov NCT03114917 and ISRCTN17776666. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 13/161/25) and is published in full in Efficacy and Mechanism Evaluation ; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information.