CARMS v1: Cognitive approaches to combatting suicidality
| ISRCTN | ISRCTN17776666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17776666 |
| IRAS number | 201644 |
| ClinicalTrials.gov number | NCT03114917 |
| Secondary identifying numbers | CPMS 33661, IRAS 201644 |
- 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
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, 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
Public
Rawnsley Building
Hathersage Road
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 271 0729 |
|---|---|
| kamelia.harris@manchester.ac.uk |
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 |
|---|---|
| patricia.a.gooding@manchester.ac.uk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | North West – GM South, 02/05/2017, ref: 17/NW/0089 |
| Condition | 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 | 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 study start date | 01/01/2017 |
| Overall study end date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 19/05/2017 |
| Recruitment end date | 30/11/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PL
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 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? |
|---|---|---|---|---|---|
| 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 |
| Results article | 16/01/2025 | 27/01/2025 | Yes | No |
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.
