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 - NCBI Bookshelf An official website of the United States government Here's how you know The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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A service of the National Library of Medicine, National Institutes of Health. < Prev Next > 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, No. 13.03 Patricia Gooding , Yvonne Awenat , Richard Drake , Richard Emsley , Steven Jones , Navneet Kapur , Fiona Lobban , Sarah Peters , Daniel Pratt , Rachel Elliott , Bradley Boardman , Elizabeth Camacho , Danielle Edwards , Kamelia Harris , Charlotte Huggett , and Gillian Haddock . Author Information and Affiliations Authors Patricia Gooding , 1,2 ,* Yvonne Awenat , 1,2 Richard Drake , 1,2 Richard Emsley , 3 Steven Jones , 4,5 Navneet Kapur , 1,2 Fiona Lobban , 4,5 Sarah Peters , 1,2 Daniel Pratt , 1,2 Rachel Elliott , 1,2,6 Bradley Boardman , 1,2 Elizabeth Camacho , 1,2,6 Danielle Edwards , 3 Kamelia Harris , 1,2 Charlotte Huggett , 1,2 and Gillian Haddock 1,2 . Affiliations 1 Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK 2 Greater Manchester Mental Health NHS Foundation Trust (formerly Manchester Mental Health and Social Care Trust), Manchester, UK 3 Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK 4 Lancashire and South Cumbria NHS Foundation Trust, Preston, UK 5 Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK 6 Manchester Centre for Health Economics, School of Health Sciences, University of Manchester, Manchester, UK * Corresponding author ; Email: [email protected] Southampton (UK): National Institute for Health and Care Research ; 2026 Mar . Copyright and Permissions Copyright © 2026 Gooding et al. This work was produced by Gooding et al . under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/ . For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Search term 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. Plain language summary Suicidal experiences are strikingly common. They are even more common in people with severe mental health problems, such as non-affective psychosis (e.g. schizophrenia). People with psychosis experience persistent and distressing hallucinations, delusions and paranoid feelings and beliefs. In order to take action against suicide, we have to better understand the psychological mind-sets of people who have suicidal experiences. Based on that understanding, we then have to develop psychological therapies which directly target these suicidal experiences. We have developed and started to test a type of psychological talking therapy which is specifically focused on suicide. In the next stage of our research, we wanted to further our understanding of the psychological mind-sets underpinning suicide, and in addition, to determine how much our suicide-focused therapy would actually reduce the severity of suicidal thoughts in people with non-affective psychosis across 6 months. We randomly split people into two groups – treatment and control. One hundred and forty-nine participants were offered our suicide-focused therapy, together with any ongoing treatment (treatment group), and 143 carried on with their usual treatment (control group). Those in the treatment group were offered up to 24 sessions of suicide-focused therapy, with each session lasting around 50 minutes and usually occurring weekly. We asked people to complete assessments at baseline, at 6 months and at 12 months. The main analyses showed that reductions in suicidal ideation severity were not significantly greater in the treatment compared to the control group across 6 months. Analyses designed to examine compliance with the therapy also did not result in a significant treatment effect. However, we did find that the suicide-focused therapy improved social support appraisals, which in turn improved suicidal ideation severity at 6 months. This indirect pathway was significant. Our qualitative interviews expanded on the impact of social support and social connectedness. Our participants also told us in qualitative work that the suicide-focused therapy was needed, acceptable and implementable in National Health Service services. Contents Expand All Collapse All Scientific summary Chapter 1. Introduction Scientific background Chapter 2. Study aims Efficacy aims Mechanism aims Clinical aims Exploratory aim Chapter 3. Methods Climate, health and sustainability Patient and public involvement and engagement and equality, diversity, inclusion and antiracist approach Design Settings Study population Sample sizes Methods to examine and protect against sources of bias in the randomised controlled trial Measures Procedures: randomised controlled trial and mechanism workstreams Treatment as usual and the treatment suicide-focused therapy intervention Cognitive–Behavioural Suicide Prevention for psychosis Safety procedures Procedures specific to the qualitative and mixed-methods workstreams Procedural changes as a consequence of the COVID-19 pandemic and associated United kingdom lockdown restrictions Chapter 4. Analyses Statistical analyses plan Missing data Health economics analyses plan: exploratory Chapter 5. Quantitative results Participant flow Breaches of protocol Serious adverse events over the course of Cognitive AppRoaches to coMbatting Suicidality Modes of conducting patient information sheet and consent procedures and carrying out the assessments Therapy process measures Participant characteristics and baseline measures overall and across the two groups of the randomised controlled trial Outcome measures at baseline Efficacy for primary and secondary suicide outcomes Compliance-adjusted analyses of the primary suicide outcome measure Health economics outcomes: exploratory Chapter 6. Qualitative and mixed-methods results Qualitative efficacy workstream: acceptability and implementation Qualitative mechanistic workstream Qualitative and mixed-methods experiences of participating in a suicide randomised controlled trial workstream Chapter 7. Discussion Main efficacy finding Compliance modelling examining the effects of a ‘dose–response’ and systematic exclusion Psychological suicide mechanisms Acceptability and implementation findings Limitations Strengths Future research directions and recommendations Clinical implications and recommendations Chapter 8. Conclusions Additional information References Appendix 1. Cognitive AppRoaches to coMbatting Suicidality protocol: non-substantial and substantial amendments Appendix 2. Procedural elements of Cognitive AppRoaches to coMbatting Suicidality prior to and following lockdown due to COVID-19 List of abbreviations Expand All Collapse All About the Series Efficacy and Mechanism Evaluation ISSN (Electronic): 2050-4373 Article history The research reported in this issue of the journal was funded by the EME programme as project number 13/161/25. The contractual start date was in January 2017. The final report began editorial review in October 2024 and was accepted for publication in July 2025. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The EME editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report. Last reviewed: October 2024; Accepted: July 2025. Copyright © 2026 Gooding et al . This work was produced by Gooding et al . under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/ . For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Bookshelf ID: NBK621220 PMID: 41812003 DOI: 10.3310/GJPG0530 < Prev Next > Share Views PubReader Print View Cite this Page Gooding P, Awenat Y, Drake R, et al. 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. Southampton (UK): National Institute for Health and Care Research; 2026 Mar. 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