Cognitive AppRoaches to coMbatting Suicidality

Not Applicable

Completed

• Conditions: Suicide Prevention; Suicidality; Psychosis
• Interventions: Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS)

• Registration Number: NCT03114917
• Lead Sponsor: University of Manchester

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-05-12
• Primary Completion: 2022-01-27
• Study Completion: 2022-01-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CARMS therapy + TAU	Cognitive AppRoaches to coMbatting Suicidality (CARMS)	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months	Baseline, 6 month and 12 month follow up	Suicidal ideation valid measure

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Suicide Probability Scale score at 6 and 12 months	Baseline, 6 month and 12 month follow up	Suicide risk valid measure
Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months	Baseline, 6 month and 12 month follow up	Clinical interview to ascertain frequency of suicidal thoughts, plans and acts across six months
Change from Baseline Frequency of Suicide Attempts at 6 and 12 months	Baseline, 6 month and 12 month follow up	Frequency of suicide attempts will be collected from medical records
Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months	Baseline, 6 month and 12 month follow up	Assess an individual's thoughts, attitudes and intentions regarding suicide

Trial Locations

Locations (4)

Pennine Care NHS Foundation Trust; 🇬🇧 Ashton under Lyne, United Kingdom

Northwest Boroughs Healthcare NHS Foundation Trust; 🇬🇧 Warrington, United Kingdom

Greater Manchester Mental Health NHS Trust; 🇬🇧 Manchester, United Kingdom

Lancashire Care NHS Foundation Trust; 🇬🇧 Chorley, United Kingdom