Cognitive AppRoaches to coMbatting Suicidality

NCT03114917 | Completed DMC

• 2 other identifiers: 13/161/25220
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 4

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.

Conditions

Psychosis; Suicide Prevention; Suicidality

Keywords

Suicide; Self-harm; Psychosis; Community; Suicide Prevention; CBT; CARMS; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from Baseline Suicide Probability Scale score 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

• 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

Other Outcomes (18)

• Change from Baseline Difficulties in Emotional Regulation Scale score at 6 and 12 months

  Baseline, 6 month and 12 month follow up

• Change from Baseline Social Problem-Solving Inventory score at 6 and 12 months

  Baseline, 6 month and 12 month follow up

• Change from Baseline Social Support Appraisals Scale score at 6 and 12 months

  Baseline, 6 month and 12 month follow up

Study Arms (2)

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.

Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS)

TAU

NO INTERVENTION

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

Interventions

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.

CARMS therapy + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Manchester: lead
• Greater Manchester Mental Health NHS Foundation Trust: collaborator
• Lancaster University: collaborator

Study Sites (4)

Pennine Care NHS Foundation Trust

Ashton-under-Lyne, United Kingdom

Location

Lancashire Care NHS Foundation Trust

Chorley, United Kingdom

Location

Greater Manchester Mental Health NHS Trust

Manchester, M13 9WL, United Kingdom

Location

Northwest Boroughs Healthcare NHS Foundation Trust

Warrington, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 39827886 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.

  PMID: 38001403 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.

  PMID: 33884617 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.

  PMID: 32546129 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Suicide Prevention; Suicidal Ideation; Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Patricia Gooding

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Gillian Haddock

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Randomised-controlled trial with a qualitative component.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 14, 2017
• Study Start: May 12, 2017
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

GB (4)