CARMS v1: Cognitive approaches to combatting suicidality

Category Primary study
Registry of TrialsISRCTN registry
Year 2017
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. CONDITION: Specialty: Mental Health, Primary sub‐specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders ; Mental and Behavioural Disorders ; Psychosis PRIMARY OUTCOME: Frequency of suicidal ideation is measured using the Adult Suicide Ideation Questionnaire score at baseline, six and 12 months. 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 SECONDARY OUTCOME: 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
Epistemonikos ID: 4d50db6578b01c49d2355d53b1860985b27ed58f
First added on: Aug 23, 2024