CARMS v1: Cognitive approaches to combatting suicidality

ISRCTN	ISRCTN17776666
DOI	https://doi.org/10.1186/ISRCTN17776666
ClinicalTrials.gov (NCT)	NCT03114917
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	201644
Protocol serial number	CPMS 33661, IRAS 201644
Sponsor	The University of Manchester
Funder	Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership

Submission date: 05/06/2017
Registration date: 05/06/2017
Last edited: 27/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Around 6% of people with psychosis die by suicide. Many more think about suicide. Talking therapies, for people with psychosis, focus mainly on treating symptoms and this does not stop people from having suicidal thoughts or making suicide attempts. A new psychological therapy called CARMS, Cognitive AppRoaches to coMbatting Suicidality, which specifically targets suicidal thoughts and behaviours has been developed. Many people with psychosis feel isolated, unable to cope emotionally, nor able to deal with their problems. Feelings of being hopeless, being trapped and/or feeling defeated often can occur, and all of these feelings can be precursors to suicide. CARMS aims to help people find ways of dealing with these sorts of negative perceptions and feelings. The aim of this study is to assess whether CARMS is effective in reducing suicidal thoughts and behaviours in people experiencing psychosis and how well it works in practice in the NHS.

Who can participate?
Adults aged 18 and older who are diagnosed with psychosis, have felt suicidal in the past three months and who are under the care of a mental health services clinical team (i.e., community or inpatient mental health care teams) with a care coordinator.
(updated 12/07/2019, previously: Adults aged 18 and older who are diagnosed with psychosis and have felt suicidal in the past three months.)

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive their usual treatment. Those in the second group receive 24 weekly sessions of CARMs therapy as well as their usual treatment. This involves 50 minutes of treatments over six months that are recovery focused, structured and socio-cognitive based. The aim of this therapy is to modify negative thoughts and improve the feeling of defeat and hopelessness. Participants are assessed for their suicidal thoughts and behaviours, appraisals of social isolation, emotion regulation, problem solving, perceptions of being defeated, trapped and hopeless prior to treatment and six and 12 months after treatment.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their psychosis and suicidal symptoms. There are no notable risks, however talking about feelings may upset participants.

Where is the study run from?
This study is being run by the University of Manchester (UK) and takes place in four NHS Trusts in the UK.

When is the study starting and how long is it expected to run for?
January 2017 to September 2022

Who is funding the study?
The Efficacy and Mechanism Evaluation (EME) programme, an MRC and NIHR partnership
(updated 12/07/2019, previously: National Institute for Health Research (UK))

Who is the main contact?
Kamelia Harris, kamelia.harris@manchester.ac.uk
Dr Patricia Gooding, patricia.a.gooding@manchester.ac.uk
(updated 18/11/2020, previously: Miss Charlotte Huggett, charlotte.huggett@manchester.ac.uk)

Contact information

Ms Kamelia Harris
Public

Rawnsley Building
Hathersage Road
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Phone	+44 (0)161 271 0729
Email	kamelia.harris@manchester.ac.uk

Dr Patricia Gooding
Scientific

School of Health Sciences
Division of Psychology and Mental Health
Coupland Building 1
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 275 1971
Email	patricia.a.gooding@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Both; Design type: Treatment, Screening, Prevention, Psychological & Behavioural, Validation of investigation /therapeutic procedures
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A psychological intervention for suicide applied to patients with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)
Study acronym	CARMS v1
Study objectives	The aim of this study is to assess whether CARMS is effective in reducing suicidal thoughts and behaviours in people experiencing psychosis and how well it works in practice in the NHS.
Ethics approval(s)	North West – GM South, 02/05/2017, ref: 17/NW/0089
Health condition(s) or problem(s) studied	Psychosis
Intervention	Participants are randomly allocated to one of two arms: treatment as usual and treatment as usual plus CARMS (Cognitive AppRoaches to coMbatting Suicidality) Therapy. Treatment as usual arm (TAU): Participants allocated to TAU receive their usual care and treatment from mental health services. CARMs therapy plus TAU arm: Participants allocated to the CARMS therapy + TAU arm receive their usual care and treatment from mental health services along with CARMS therapy. The CARMS therapy comprises of 24 sessions, each up to 50 minutes long over a six month period. The investigators' psychological therapy is a recovery-focused, structured, time-limited, socio-cognitive intervention. It is based upon the investigators' recently developed treatment manual and pilot RCTs in the community and in prison. 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. Participants are assessed for their suicidal thoughts and behaviours, appraisals of social isolation, emotion regulation, problem solving, perceptions of being defeated, trapped and hopeless at baseline and six and 12 months after treatment.
Intervention type	Behavioural
Primary outcome measure(s)	Frequency of suicidal ideation is measured using the Adult Suicide Ideation Questionnaire score at baseline, six and 12 months.
Key secondary outcome measure(s)	1. Suicide risk is measured using the Suicide Probability Scale score at baseline, six and 12 months 2. Thoughts, attitudes and intentions regarding suicide is measured using the Beck Scale for Suicidal ideation score at baseline, six and 12 months 3. Frequency of suicidal thoughts, plans and acts are measured using a clinical interview at baseline, six and 12 months 4. Frequency of suicide attempts are measured using medical records at baseline, six and 12 months 5. Emotional dysregulation are measured using the Emotional Regulation Scale score at baseline, six and 12 months 6. Individual social problem-solving skills are measured using the Social Problem-Solving Inventory score at baseline, six and 12 months 7. Individual's appraisals of social support are measured using the Social Support Appraisals Scale score at baseline, six and 12 months 8. Hopelessness (feelings about the future, loss of motivation, and expectations) is measured using the Beck Hopelessness Scale score at baseline, six and 12 months 9. Feelings of defeat and feeling trapped are measured using the Defeat and Entrapment scale scores at baseline, six and 12 months 10. Symptom severity of individual's experiencing Schizophrenia is measured using the Positive and Negative Syndrome Scale score at baselines, six and 12 months 11. Psychosis symptoms are measured using the Psychotic Symptoms Ratings Scale (PSYRATS) score at baseline, six and 12 months 12. Personal and social functioning in individual's experiencing Schizophrenia is measured using the Personal and Social Performance Scale score at baseline, six and 12 months 13. Symptoms of depression in individual's experiencing Schizophrenia are measured using the Calgary Depression Scale score at baseline, six and 12 months 14. Frequency and type of substance misuse over 3 months are measured using clinical interviews at baseline, six and 12 months 15. Drug 'abuse' is measured using the drug use (self-reported) DAST score at baseline, six and 12 months 16. Alcohol use is measured using the alcohol use (self-reported) AUDIT score at baseline, six and 12 months 17. Individual's reasons for using alcohol and drugs respectively are measured using the Reasons for substance Use Scale - Alcohol and Drugs scores at baseline, six and 12 months 18. Insomnia is measured using the Sleep Condition Indicator (SCI) score at baseline, six and 12 months 19. Current medication for mental health problems (information regarding which anti-psychotic medication, if the medication is atypical, and the dosage will be collected from medical records) as prescribed at baseline 20. Client-therapist therapeutic alliance from the participant's and the therapist's perspective is measured using the Working Alliance Inventory - short form score at baseline, six and 12 months 21. Health outcomes are measured using the EQ-5D score at baseline and 12 months 22. Use of services are measured using the Client Service Use Receipt Inventory at baseline and 12 months
Completion date	30/09/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	250
Key inclusion criteria	Current inclusion criteria as of 05/05/2020: 1. ICD-10 diagnosis of psychosis 2. Suicidality in the past three months 3. In contact with mental health services and under the care of a mental health services clinical team (e.g., community or inpatient mental health care teams) with a care coordinator 4. Aged 18 or over 5. English-speaking (hence, not needing an interpreter) 6. 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 _____ Previous inclusion criteria: 1. ICD-10 diagnosis of psychosis 2. Suicidality in the past three months 3. In contact with mental health services and under the care of a mental health services clinical team (e.g., community mental health care teams) with a care coordinator 4. Aged 18 or over 5. English-speaking (hence, not needing an interpreter) 6. 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
Key exclusion criteria	Current inclusion criteria as of 05/05/2020: 1. Dementia, or an organic brain disorder 2. Unable to complete assessments due to language barriers 3. Currently taking part in a clinical trial _____ Previous exclusion criteria: 1. Dementia, or an organic brain disorder 2. Unable to complete assessments due to language barriers
Date of first enrolment	19/05/2017
Date of final enrolment	30/11/2020

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Manchester

Oxford Road
Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		16/01/2025	27/01/2025	Yes	No
Protocol article	protocol	16/06/2020	18/06/2020	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Qualitative study results	24/11/2023	27/11/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/01/2025: Publication reference added.
13/09/2023: The following changes were made:
1. IRAS number added.
2. ClinicalTrials.gov number added.
3. The Intention to publish date was changed from 30/09/2023 to 31/12/2023.
13/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 30/09/2022.
2. The intention to publish date was changed from 31/12/2022 to 30/09/2023.
3. The plain English summary was updated to reflect these changes.
20/09/2021: Internal review.
18/11/2020: The following changes were made to the trial record:
1. The study contacts were updated.
2. The plain English summary was updated to reflect these changes.
18/08/2020: Recruitment to this study is no longer paused. The recruitment end date was changed from 31/07/2020 to 30/11/2020.
18/06/2020: Publication reference added.
05/05/2020: The following changes were made to the trial record:
1. The target number of participants was changed from "Planned Sample Size: 280; UK Sample Size: 280" to "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".
2. The total target enrolment was changed from 280 to 250.
3. The inclusion criteria were changed.
4. The exclusion criteria were changed.
01/05/2020: Due to current public health guidance, recruitment for this study has been paused.
12/07/2019: The following changes were made to the trial record:
1. The trial website was added.
2. The plain English summary was updated.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
4. The funder name was changed from "National Institute for Health Research (NIHR)" to "Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership."
09/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 31/07/2020.
2. The overall end date was changed from 31/12/2020 to 31/12/2021.
3. The plain English summary was updated to reflect these changes.
03/04/2019: The condition has been changed from "Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders" to "Psychosis" following a request from the NIHR.
06/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.