Cognitive AppRoaches to coMbatting Suicidality

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)

Conditions
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Psychosis, Suicide Prevention, Suicidality

Intervention / Treatment
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* Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD-10 diagnosis of psychosis (i.e. F20 - F29) suicidal thoughts and/or acts in the past three months in contact with mental health services and under the care of a mental health services clinical team (i.e., community or inpatient mental health care teams) with a care coordinator aged 18 or over English-speaking (hence, not needing an interpreter) able to give informed consent as assessed by either a responsible clinician or by trial RAs following the British Psychological Society's guidelines on gaining informed consent (http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf) Exclusion Criteria: dementia, or an organic brain disorder unable to complete assessments due to language barriers currently taking part in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised-controlled trial with a qualitative component.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARMS therapy + TAU<br>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. | Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS)<br>* 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.<br>|
| No Intervention: TAU<br>Participants allocated to treatment as usual (TAU) will receive their usual care and treatment from mental health services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, Self-harm, Psychosis, Community, Suicide Prevention, CBT, CARMS, Randomised controlled trial