Cognitive AppRoaches to coMbatting Suicidality

Psychosis Clinical Trial

— CARMS  

Official title:

A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114917
• Other study ID #: 13/161/25
• Secondary ID: 220
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: January 27, 2022

Study information

• Verified date: May 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Suicidal Ideation
• Suicidality
• Suicide
• Suicide Prevention

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Pennine Care NHS Foundation Trust	Ashton under Lyne
United Kingdom	Lancashire Care NHS Foundation Trust	Chorley
United Kingdom	Greater Manchester Mental Health NHS Trust	Manchester
United Kingdom	Northwest Boroughs Healthcare NHS Foundation Trust	Warrington

Sponsors (3)

Lead Sponsor	Collaborator
University of Manchester	Greater Manchester Mental Health NHS Foundation Trust, Lancaster University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Difficulties in Emotional Regulation Scale score at 6 and 12 months	The questionnaire measures emotional dysregulation	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Social Problem-Solving Inventory score at 6 and 12 months	The questionnaire measures individual's social problem-solving skills	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Social Support Appraisals Scale score at 6 and 12 months	The questionnaire measures individual's appraisals of social support	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Beck Hopelessness Scale score at 6 and 12 months	The questionnaire measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Defeat and Entrapment scale scores at 6 and 12 months	The questionnaire measures how defeated and trapped individuals feel respectively	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Positive and Negative Syndrome Scale score at 6 and 12 months	Clinical interview to assess symptom severity of individual's experiencing Schizophrenia	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Psychotic Symptoms Ratings Scale (PSYRATS) score at 6 and 12 months	Clinical interview to assess symptoms of psychosis	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Personal and Social Performance Scale score at 6 and 12 months	Clinical interview to assess personal and social functioning in individual's experiencing Schizophrenia	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Calgary Depression Scale score at 6 and 12 months	Clinical interview to assess symptoms of depression in individual's experiencing Schizophrenia	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Frequency and Type of Substance Misuse as measured by the Timeline Follow Back at 6 and 12 months	Clinical interview to ascertain frequency and type of substance misuse over 3 months	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Drug use (self-reported) DAST score at 6 and 12 months	Measure which identifies drug 'abuse'	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Alcohol use (self-reported) AUDIT score at 6 and 12 months	Gold standard measure which identifies alcohol use	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Reasons for substance Use Scale - Alcohol and Drugs scores at 6 and 12 months	Questionnaire measure which identifies individual's reasons for using alcohol and drugs respectively	Baseline, 6 month and 12 month follow up
Other	Change from Baseline Sleep Condition Indicator score at 6 and 12 months	The questionnaire measures insomnia	Baseline, 6 month and 12 month follow up
Other	Current medication for mental health problems as prescribed at baseline assessment time point	Information regarding which anti-psychotic medication, if the medication is atypical, and the dosage will be collected from medical records	Baseline
Other	Change from Baseline Working Alliance Inventory - short form score at 6 and 12 months	The questionnaire measure the client-therapist therapeutic alliance from the participant's and the therapist's perspective	Baseline, 6 month and 12 month follow up
Other	Change from Baseline EQ-5D score at 12 months	The questionnaire measures health outcomes	Baseline and 12 month follow up
Other	Change from Baseline Client Service Use Receipt Inventory at 12 months	The questionnaire measures use of services	Baseline and 12 month follow up
Primary	Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months	Suicidal ideation valid measure	Baseline, 6 month and 12 month follow up
Secondary	Change from Baseline Suicide Probability Scale score at 6 and 12 months	Suicide risk valid measure	Baseline, 6 month and 12 month follow up
Secondary	Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months	Assess an individual's thoughts, attitudes and intentions regarding suicide	Baseline, 6 month and 12 month follow up
Secondary	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	Baseline, 6 month and 12 month follow up
Secondary	Change from Baseline Frequency of Suicide Attempts at 6 and 12 months	Frequency of suicide attempts will be collected from medical records	Baseline, 6 month and 12 month follow up