Clinical trial NCT03114917: Cognitive AppRoaches to coMbatting Suicidality
Official title: A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Suicide Prevention
Suicidality
Keywords: Suicide
Self-harm
Psychosis
Community
Suicide Prevention
CBT
CARMS
Randomised controlled trial
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Greater Manchester Mental Health NHS Foundation Trust
name: Lancaster University
First posted: 2017-04-14
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised-controlled trial with a qualitative component.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
Secondary outcomes:
measure: Change from Baseline Suicide Probability Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Frequency of Suicide Attempts at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
Other outcomes:
measure: Change from Baseline Difficulties in Emotional Regulation Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Social Problem-Solving Inventory score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Social Support Appraisals Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Beck Hopelessness Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Defeat and Entrapment scale scores at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Positive and Negative Syndrome Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Psychotic Symptoms Ratings Scale (PSYRATS) score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Personal and Social Performance Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Calgary Depression Scale score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Frequency and Type of Substance Misuse as measured by the Timeline Follow Back at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Drug use (self-reported) DAST score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Alcohol use (self-reported) AUDIT score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Reasons for substance Use Scale - Alcohol and Drugs scores at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline Sleep Condition Indicator score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Current medication for mental health problems as prescribed at baseline assessment time point
timeFrame: Baseline
measure: Change from Baseline Working Alliance Inventory - short form score at 6 and 12 months
timeFrame: Baseline, 6 month and 12 month follow up
measure: Change from Baseline EQ-5D score at 12 months
timeFrame: Baseline and 12 month follow up
measure: Change from Baseline Client Service Use Receipt Inventory at 12 months
timeFrame: Baseline and 12 month follow up
Locations:
city: Ashton under Lyne
country: United Kingdom
facility: Pennine Care NHS Foundation Trust
city: Chorley
country: United Kingdom
facility: Lancashire Care NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Trust
city: Warrington
country: United Kingdom
facility: Northwest Boroughs Healthcare NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Patricia Gooding
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Gillian Haddock
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.