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| ID | Type | Description | Link |
|---|---|---|---|
| 220 | Other Identifier | Greater Manchester Mental Health NHS Foundation Trust |
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| Name | Class |
|---|---|
| Greater Manchester Mental Health NHS Foundation Trust | OTHER |
| Lancaster University | OTHER |
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This is a randomised controlled trial which investigates the effectiveness of CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and how well CARMS works in practice within the NHS. The trial will compare two groups of people with psychosis who are using 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.
Estimates show that around 6% of people with experiences of psychosis die by suicide. Many more think about it and attempt suicide. A meta-analysis by the investigators illustrated that psychological therapies are effective in reducing suicidal thoughts and acts in people with psychosis as long as those therapies target suicidal thoughts, intentions and plans, and not the reduction of symptoms of mental illnesses. Based on this work, we have designed a psychological cognitive "talking" therapy (called CARMS) to reduce suicidal thoughts in people with experiences of psychosis which targets the psychological processes thought to underpin the pathways to suicidal thoughts and behaviours. An increasing body of work shows that many people with psychosis experience social isolation, emotional dysregulation, and poor interpersonal problem-solving. These appraisals can then induce and intensify perceptions of being hopeless, trapped and defeated, which in turn leads to suicidal thoughts and acts. CARMS aims to help people find practical ways to change these sorts of perceptions. Two of the investigators' pilot randomised trials have demonstrated that CARMS is feasible and acceptable to people experiencing psychosis and may have the potential to be effective at reducing key suicide outcomes.
Hence, the investigators' next step is to test the efficacy of CARMS in the context of NHS mental health services and also to test whether the underlying psychological mechanisms on which CARMS is based are correct. The investigators will test CARMS using a medium sized randomised controlled trial (RCT), with two arms of CARMS plus treatment as usual versus just treatment as usual. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. The investigators will use both quantitative and qualitative methods and analyses to assess CARMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARMS therapy + TAU | Experimental | Participants allocated to the CARMS therapy + TAU arm will receive their usual care and treatment from mental health services along with CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy. The CARMS therapy comprises of 24 sessions, each up to 50 minutes long over a 6 month period. |
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| TAU | No Intervention | Participants allocated to treatment as usual (TAU) will receive their usual care and treatment from mental health services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive AppRoaches to coMbatting Suicidality (CARMS) | Other | The investigators' psychological therapy is a recovery-focused, structured, time-limited, socio-cognitive intervention. It is based upon the investigators' recently developed treatment manual (Tarrier et al., 2013) and pilot RCTs in the community (Tarrier et al., 2014) and in prison (Tarrier et al., accepted). The intervention modifies negative appraisals of emotional regulation, social support, and interpersonal problem-solving. As a consequence, perceptions of defeat, entrapment, and hopelessness will be improved indirectly. In addition, perceptions of defeat, entrapment, and hopelessness will be worked on directly during the therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months | Suicidal ideation valid measure | Baseline, 6 month and 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Suicide Probability Scale score at 6 and 12 months | Suicide risk valid measure | Baseline, 6 month and 12 month follow up |
| Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Difficulties in Emotional Regulation Scale score at 6 and 12 months | The questionnaire measures emotional dysregulation | Baseline, 6 month and 12 month follow up |
| Change from Baseline Social Problem-Solving Inventory score at 6 and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Gooding | University of Manchester | Principal Investigator |
| Gillian Haddock | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennine Care NHS Foundation Trust | Ashton-under-Lyne | United Kingdom | ||||
| Lancashire Care NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41257613 | Derived | Gooding P, Harris K, Peters S, Haddock G. The dynamic interplay between anxiety-related, psychotic, and suicidal experiences: a qualitative study. BMC Psychiatry. 2025 Nov 19;25(1):1105. doi: 10.1186/s12888-025-07547-z. | |
| 39827886 | Derived | Gooding P, Pratt D, Edwards D, Awenat Y, Drake RJ, Emsley R, Jones S, Kapur N, Lobban F, Peters S, Boardman B, Harris K, Huggett C, Haddock G. Underlying mechanisms and efficacy of a suicide-focused psychological intervention for psychosis, the Cognitive Approaches to Combatting Suicidality (CARMS): a multicentre, assessor-masked, randomised controlled trial in the UK. Lancet Psychiatry. 2025 Mar;12(3):177-188. doi: 10.1016/S2215-0366(24)00399-7. Epub 2025 Jan 16. |
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The investigators are undecided at present.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D000092864 | Suicide Prevention |
| D059020 | Suicidal Ideation |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Randomised-controlled trial with a qualitative component.
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All Research Assistants will be blinded to treatment allocation. The Research Assistants will be carrying out outcomes assessments at baseline, 6 month and 12 month.
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Assess an individual's thoughts, attitudes and intentions regarding suicide
| Baseline, 6 month and 12 month follow up |
| Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months | Clinical interview to ascertain frequency of suicidal thoughts, plans and acts across six months | Baseline, 6 month and 12 month follow up |
| Change from Baseline Frequency of Suicide Attempts at 6 and 12 months | Frequency of suicide attempts will be collected from medical records | Baseline, 6 month and 12 month follow up |
The questionnaire measures individual's social problem-solving skills |
| Baseline, 6 month and 12 month follow up |
| Change from Baseline Social Support Appraisals Scale score at 6 and 12 months | The questionnaire measures individual's appraisals of social support | Baseline, 6 month and 12 month follow up |
| Change from Baseline Beck Hopelessness Scale score at 6 and 12 months | The questionnaire measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations | Baseline, 6 month and 12 month follow up |
| Change from Baseline Defeat and Entrapment scale scores at 6 and 12 months | The questionnaire measures how defeated and trapped individuals feel respectively | Baseline, 6 month and 12 month follow up |
| Change from Baseline Positive and Negative Syndrome Scale score at 6 and 12 months | Clinical interview to assess symptom severity of individual's experiencing Schizophrenia | Baseline, 6 month and 12 month follow up |
| Change from Baseline Psychotic Symptoms Ratings Scale (PSYRATS) score at 6 and 12 months | Clinical interview to assess symptoms of psychosis | Baseline, 6 month and 12 month follow up |
| Change from Baseline Personal and Social Performance Scale score at 6 and 12 months | Clinical interview to assess personal and social functioning in individual's experiencing Schizophrenia | Baseline, 6 month and 12 month follow up |
| Change from Baseline Calgary Depression Scale score at 6 and 12 months | Clinical interview to assess symptoms of depression in individual's experiencing Schizophrenia | Baseline, 6 month and 12 month follow up |
| Change from Baseline Frequency and Type of Substance Misuse as measured by the Timeline Follow Back at 6 and 12 months | Clinical interview to ascertain frequency and type of substance misuse over 3 months | Baseline, 6 month and 12 month follow up |
| Change from Baseline Drug use (self-reported) DAST score at 6 and 12 months | Measure which identifies drug 'abuse' | Baseline, 6 month and 12 month follow up |
| Change from Baseline Alcohol use (self-reported) AUDIT score at 6 and 12 months | Gold standard measure which identifies alcohol use | Baseline, 6 month and 12 month follow up |
| Change from Baseline Reasons for substance Use Scale - Alcohol and Drugs scores at 6 and 12 months | Questionnaire measure which identifies individual's reasons for using alcohol and drugs respectively | Baseline, 6 month and 12 month follow up |
| Change from Baseline Sleep Condition Indicator score at 6 and 12 months | The questionnaire measures insomnia | Baseline, 6 month and 12 month follow up |
| Current medication for mental health problems as prescribed at baseline assessment time point | Information regarding which anti-psychotic medication, if the medication is atypical, and the dosage will be collected from medical records | Baseline |
| Change from Baseline Working Alliance Inventory - short form score at 6 and 12 months | The questionnaire measure the client-therapist therapeutic alliance from the participant's and the therapist's perspective | Baseline, 6 month and 12 month follow up |
| Change from Baseline EQ-5D score at 12 months | The questionnaire measures health outcomes | Baseline and 12 month follow up |
| Change from Baseline Client Service Use Receipt Inventory at 12 months | The questionnaire measures use of services | Baseline and 12 month follow up |
| Chorley |
| United Kingdom |
| Greater Manchester Mental Health NHS Trust | Manchester | M13 9WL | United Kingdom |
| Northwest Boroughs Healthcare NHS Foundation Trust | Warrington | United Kingdom |
| 38001403 | Derived | Gooding P, Haddock G, Harris K, Asriah M, Awenat Y, Cook L, Drake RJ, Emsley R, Huggett C, Jones S, Lobban F, Marshall P, Pratt D, Peters S. The interplay between suicidal experiences, psychotic experiences and interpersonal relationships: a qualitative study. BMC Psychiatry. 2023 Nov 24;23(1):873. doi: 10.1186/s12888-023-05164-2. |
| 33884617 | Derived | Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. |
| 32546129 | Derived | Gooding PA, Pratt D, Awenat Y, Drake R, Elliott R, Emsley R, Huggett C, Jones S, Kapur N, Lobban F, Peters S, Haddock G. A psychological intervention for suicide applied to non-affective psychosis: the CARMS (Cognitive AppRoaches to coMbatting Suicidality) randomised controlled trial protocol. BMC Psychiatry. 2020 Jun 16;20(1):306. doi: 10.1186/s12888-020-02697-8. |