Cognitive AppRoaches to coMbatting Suicidality

NCT ID: NCT03114917

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2022-01-27

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.

Conditions

Psychosis; Suicide Prevention; Suicidality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CARMS therapy + TAU

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.

Group Type: EXPERIMENTAL

Cognitive AppRoaches to coMbatting Suicidality (CARMS)

Intervention Type: 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.

TAU

Participants allocated to treatment as usual (TAU) will receive their usual care and treatment from mental health services.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive AppRoaches to coMbatting Suicidality (CARMS)

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Greater Manchester Mental Health NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Lancaster University

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Patricia Gooding

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Gooding

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Gillian Haddock

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Pennine Care NHS Foundation Trust

Ashton-under-Lyne, , United Kingdom

Lancashire Care NHS Foundation Trust

Chorley, , United Kingdom

Greater Manchester Mental Health NHS Trust

Manchester, , United Kingdom

Northwest Boroughs Healthcare NHS Foundation Trust

Warrington, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39827886 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38001403 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32546129 (View on PubMed)

Other Identifiers

220

Identifier Type: OTHER

Identifier Source: secondary_id

13/161/25

Identifier Type: -

Identifier Source: org_study_id