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临床试验/NCT03114917
NCT03114917已完成不适用

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

University of Manchester5 个研究点 分布在 1 个国家目标入组 329 人开始时间: 2017年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
329
试验地点
5
主要终点
Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • dementia, or an organic brain disorder
  • unable to complete assessments due to language barriers
  • currently taking part in a clinical trial.

结局指标

主要结局

Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months

时间窗: Baseline, 6 month and 12 month follow up

Suicidal ideation valid measure

次要结局

  • Change from Baseline Suicide Probability Scale score at 6 and 12 months(Baseline, 6 month and 12 month follow up)
  • Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months(Baseline, 6 month and 12 month follow up)
  • Change from Baseline Frequency of Suicide Attempts at 6 and 12 months(Baseline, 6 month and 12 month follow up)
  • Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months(Baseline, 6 month and 12 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Gooding

Senior Lecturer

University of Manchester

研究点 (5)

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