Condition category
Mental and Behavioural Disorders
Date applied
05/06/2017
Date assigned
05/06/2017
Last edited
06/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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 June 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Charlotte Huggett
charlotte.huggett@manchester.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Charlotte Huggett

ORCID ID

http://orcid.org/0000-0002-7566-6224

Contact details

3rd Floor
Rawnsley Building
Hathersage Road
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
+44 161 276 3301
charlotte.huggett@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33661

Study information

Scientific title

A psychological intervention for suicide applied to patients with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)

Acronym

CARMS v1

Study hypothesis

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

North West – GM South, 02/05/2017, ref: 17/NW/0089

Study design

Randomised; Both; Design type: Treatment, Screening, Prevention, Psychological & Behavioural, Validation of investigation /therapeutic procedures

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders

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

Phase

Drug names

Primary outcome measures

Frequency of suicidal ideation is measured using the Adult Suicide Ideation Questionnaire score at baseline, six and 12 months.

Secondary outcome measures

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

Overall trial start date

01/01/2017

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 280; UK Sample Size: 280

Participant exclusion criteria

1. Dementia, or an organic brain disorder
2. Unable to complete assessments due to language barriers

Recruitment start date

19/05/2017

Recruitment end date

30/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

The University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial protocol will be submitted to BMC Psychiatry. The main outcome paper will be submitted to the NIHR open access journal of Efficacy and Mechanism Evaluation, and Lancet: Psychiatry. One staff and one service user qualitative results papers will be submitted to BJP and Qualitative Health Research, respectively. The paper regarding mediational pathways leading from appraisals of emotion regulation, social isolation and problem solving to suicide in those with psychosis, via perceptions of defeat, entrapment, and hopelessness will be submitted to Journal of Abnormal Psychology. The paper regarding the role of symptoms of psychosis in the above pathways to suicidality will be submitted to Psychological Medicine.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes