- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03114917
Cognitive AppRoaches to coMbatting Suicidality (CARMS)
A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ashton under Lyne, United Kingdom
- Pennine Care NHS Foundation Trust
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Chorley, United Kingdom
- Lancashire Care NHS Foundation Trust
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Manchester, United Kingdom, M13 9WL
- Greater Manchester Mental Health NHS Trust
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Warrington, United Kingdom
- Northwest Boroughs Healthcare NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- dementia, or an organic brain disorder
- unable to complete assessments due to language barriers
- currently taking part in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CARMS therapy + TAU
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.
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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.
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No Intervention: TAU
Participants allocated to treatment as usual (TAU) will receive their usual care and treatment from mental health services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Suicidal ideation valid measure
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Baseline, 6 month and 12 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Suicide Probability Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Suicide risk valid measure
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Baseline, 6 month and 12 month follow up
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Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Assess an individual's thoughts, attitudes and intentions regarding suicide
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Baseline, 6 month and 12 month follow up
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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
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Clinical interview to ascertain frequency of suicidal thoughts, plans and acts across six months
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Baseline, 6 month and 12 month follow up
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Change from Baseline Frequency of Suicide Attempts at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Frequency of suicide attempts will be collected from medical records
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Baseline, 6 month and 12 month follow up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Difficulties in Emotional Regulation Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measures emotional dysregulation
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Baseline, 6 month and 12 month follow up
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Change from Baseline Social Problem-Solving Inventory score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measures individual's social problem-solving skills
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Baseline, 6 month and 12 month follow up
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Change from Baseline Social Support Appraisals Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measures individual's appraisals of social support
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Baseline, 6 month and 12 month follow up
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Change from Baseline Beck Hopelessness Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations
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Baseline, 6 month and 12 month follow up
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Change from Baseline Defeat and Entrapment scale scores at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measures how defeated and trapped individuals feel respectively
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Baseline, 6 month and 12 month follow up
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Change from Baseline Positive and Negative Syndrome Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Clinical interview to assess symptom severity of individual's experiencing Schizophrenia
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Baseline, 6 month and 12 month follow up
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Change from Baseline Psychotic Symptoms Ratings Scale (PSYRATS) score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Clinical interview to assess symptoms of psychosis
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Baseline, 6 month and 12 month follow up
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Change from Baseline Personal and Social Performance Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Clinical interview to assess personal and social functioning in individual's experiencing Schizophrenia
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Baseline, 6 month and 12 month follow up
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Change from Baseline Calgary Depression Scale score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Clinical interview to assess symptoms of depression in individual's experiencing Schizophrenia
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Baseline, 6 month and 12 month follow up
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Change from Baseline Frequency and Type of Substance Misuse as measured by the Timeline Follow Back at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Clinical interview to ascertain frequency and type of substance misuse over 3 months
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Baseline, 6 month and 12 month follow up
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Change from Baseline Drug use (self-reported) DAST score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Measure which identifies drug 'abuse'
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Baseline, 6 month and 12 month follow up
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Change from Baseline Alcohol use (self-reported) AUDIT score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Gold standard measure which identifies alcohol use
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Baseline, 6 month and 12 month follow up
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Change from Baseline Reasons for substance Use Scale - Alcohol and Drugs scores at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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Questionnaire measure which identifies individual's reasons for using alcohol and drugs respectively
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Baseline, 6 month and 12 month follow up
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Change from Baseline Sleep Condition Indicator score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measures insomnia
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Baseline, 6 month and 12 month follow up
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Current medication for mental health problems as prescribed at baseline assessment time point
Time Frame: Baseline
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Information regarding which anti-psychotic medication, if the medication is atypical, and the dosage will be collected from medical records
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Baseline
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Change from Baseline Working Alliance Inventory - short form score at 6 and 12 months
Time Frame: Baseline, 6 month and 12 month follow up
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The questionnaire measure the client-therapist therapeutic alliance from the participant's and the therapist's perspective
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Baseline, 6 month and 12 month follow up
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Change from Baseline EQ-5D score at 12 months
Time Frame: Baseline and 12 month follow up
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The questionnaire measures health outcomes
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Baseline and 12 month follow up
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Change from Baseline Client Service Use Receipt Inventory at 12 months
Time Frame: Baseline and 12 month follow up
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The questionnaire measures use of services
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Baseline and 12 month follow up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patricia Gooding, University of Manchester
- Principal Investigator: Gillian Haddock, University of Manchester
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/161/25
- 220 (Other Identifier: Greater Manchester Mental Health NHS Foundation Trust)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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