PsychosisCARMSNCT03114917
Cognitive AppRoaches to coMbatting Suicidality
A study testing Cognitive AppRoaches to coMbatting Suicidality (CARMS) in people with Psychosis and Suicide Prevention, run by University of Manchester at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis, Suicide Prevention, Suicidality
- What is being tested?
- Cognitive AppRoaches to coMbatting Suicidality (CARMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 12 May 2017to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- dementia, or an organic brain disorder
- unable to complete assessments due to language barriers
- currently taking part in a clinical trial.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Pennine Care NHS Foundation Trust
Ashton-under-Lyne
Lancashire Care NHS Foundation Trust
Chorley
Greater Manchester Mental Health NHS Trust
Manchester, M13 9WL
Northwest Boroughs Healthcare NHS Foundation Trust
Warrington
About this study
Official title: A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
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.
Read the 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
- Being tested
- Cognitive AppRoaches to coMbatting Suicidality (CARMS)
- Keywords
- Suicide, Self-harm, Psychosis, Community, Suicide Prevention, CBT, CARMS, Randomised controlled trial
- Medical subject headings
- Psychotic Disorders, Suicide Prevention, Suicidal Ideation, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months
Suicidal ideation valid measure
Measured: Baseline, 6 month and 12 month follow up
Secondary outcomes (4)
Change from Baseline Suicide Probability Scale score at 6 and 12 months
Suicide risk valid measure
Measured: Baseline, 6 month and 12 month follow up
Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months
Assess an individual's thoughts, attitudes and intentions regarding suicide
Measured: Baseline, 6 month and 12 month follow up
Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months
Clinical interview to ascertain frequency of suicidal thoughts, plans and acts across six months
Measured: Baseline, 6 month and 12 month follow up
Change from Baseline Frequency of Suicide Attempts at 6 and 12 months
Frequency of suicide attempts will be collected from medical records
Measured: Baseline, 6 month and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start12 May 2017
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised-controlled trial with a qualitative component.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust, Lancaster University
- Responsible party
- Principal investigator, Patricia Gooding, University of Manchester
- Investigators
- Patricia Gooding, Principal investigator, University of ManchesterGillian Haddock, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114917
- Sponsor's protocol ID
- 13/161/25
- Other IDs
- 220
- Acronym
- CARMS
- Status last verified
- May 2023
- First submitted
- 29 Mar 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are undecided at present.
Publications
Gooding P, Harris K, Peters S, Haddock G. The dynamic interplay between anxiety-related, psychotic, and suicidal experiences: a qualitative study. BMC Psychiatry. 2025 Nov 19;25(1):1105. doi: 10.1186/s12888-025-07547-z.
PubMed 41257613Gooding 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.
PubMed 39827886Gooding 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.
PubMed 38001403Witt 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.
PubMed 33884617Gooding 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.
PubMed 32546129
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
- ClinicalTrials.gov ID
- NCT03114917
- Acronym / sponsor ID
- CARMS / 13/161/25
- Conditions
- Psychosis, Suicide Prevention, Suicidality
- Keywords
- Suicide, Self-harm, Psychosis, Community, Suicide Prevention, CBT, CARMS, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust, Lancaster University
- Study start
- 12 May 2017 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised-controlled trial with a qualitative component.
| Arm | Type | Receives |
|---|---|---|
| CARMS therapy + TAU | Experimental | Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS)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. |
| TAU | No intervention | –Participants allocated to treatment as usual (TAU) will receive their usual care and treatment from mental health services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- dementia, or an organic brain disorder
- unable to complete assessments due to language barriers
- currently taking part in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | CARMS therapy + TAU |
Primary outcome
Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months
Time frame: Baseline, 6 month and 12 month follow up
Suicidal ideation valid measure
4 secondary outcomes
Change from Baseline Suicide Probability Scale score at 6 and 12 months
Time frame: Baseline, 6 month and 12 month follow up
Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months
Time frame: Baseline, 6 month and 12 month follow up
Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months
Time frame: Baseline, 6 month and 12 month follow up
Change from Baseline Frequency of Suicide Attempts at 6 and 12 months
Time frame: Baseline, 6 month and 12 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 41257613Gooding P, Harris K, Peters S, Haddock G. The dynamic interplay between anxiety-related, psychotic, and suicidal experiences: a qualitative study. BMC Psychiatry. 2025 Nov 19;25(1):1105. doi: 10.1186/s12888-025-07547-z.
- Derived from this study: PubMed 39827886Gooding 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.
- Derived from this study: PubMed 38001403Gooding 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.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 32546129Gooding 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.
- Individual participant dataSharing planned: Undecided. The investigators are undecided at present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Gooding principal investigator
University of Manchester
Gillian Haddock principal investigator
University of Manchester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive AppRoaches to coMbatting Suicidality (CARMS) in people with Psychosis and Suicide Prevention, run by University of Manchester at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (time frame: Baseline, 6 month and 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114917, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.